A Single-blind, Randomised Home-use Study, In 50 Healthy Male And .
PCR CORP REPORT: NUTUSE1M13th December 2016A SINGLE-BLIND, RANDOMISED HOME-USE STUDY, IN 50 HEALTHY MALE AND FEMALEVOLUNTEERS, WITH SELF-ASSESSED ANXIETY, TO EVALUATE THE EFFICACY OF ONENUTRITIONAL SUPPLEMENT COMPARED TO PLACEBO, AS MEASURED BY SELF-PERCEPTIONQUESTIONNAIRE (SPQ).Prepared for:Prepared by:Nutreance401 Riversville RoadGreenwichCT. 06831USAPCR Corp.8 Richmond RoadDukes ParkChelmsfordEssex, CM2 6UADraft Report: 14th October 2016Draft Report v2: 20th October 2016Draft Report v3: 25th October 2016Final Report: 26th October 2016Final Report v2: 13th December 2016Final v2Page 1 of 30
PCR CORP REPORT: NUTUSE1M13th December 2016A SINGLE-BLIND, RANDOMISED HOME-USE STUDY, IN 50 HEALTHY MALE AND FEMALEVOLUNTEERS, WITH SELF-ASSESSED ANXIETY, TO EVALUATE THE EFFICACY OF ONENUTRITIONAL SUPPLEMENT COMPARED TO PLACEBO, AS MEASURED BY SELF-PERCEPTIONQUESTIONNAIRE (SPQ).PCR CORP REPORT NO: NUTUSE1MI declare that the following report constitutes a true and faithful account of the proceduresadopted and the results obtained in the performance of this study. The aspects of the studyconducted by PCR Corp. were performed, where relevant, in accordance with theprinciples of Good Clinical Research Practice.Barrie Drewitt(Principal Investigator).13th December 2016Date .Jo Broyd(Project Manager).Bbeuioa13th December 2016Date .QUALITY ASSURANCE STATEMENTThis report has been audited and is considered to be an accurate description of themethods used and an accurate presentation of the data obtained during the conduct ofthe study.Reece Statham(Quality Assurance Manager)shih.13th December 2016Date .Final v2Page 2 of 30
PCR CORP REPORT: NUTUSE1M13th December 2016CONTENTS1SUMMARY .42KEY STUDY PERSONNEL AND RESPONSIBILITIES .53INTRODUCTION AND OBJECTIVES .64STUDY DESIGN .65SELECTION OF SUBJECTS .66TEST ARTICLES .77STUDY PROCEDURE .78STUDY ETHICS .89RESULTS .9APPENDIX 1: SUBJECT CONSENT FORM .13APPENDIX 2: SUBJECT INFORMATION SHEET – NUTUSE1M .16APPENDIX 3: PRE-TREATMENT QUESTIONNAIRE .17APPENDIX 4: TEST ARTICLES INCI LISTINGS .19APPENDIX 5: RANDOMISATION .20APPENDIX 6: SUBJECT DIARY .21APPENDIX 7: SELF-PERCEPTION QUESTIONNAIRE .23APPENDIX 8: SELF-PERCEPTION QUESTIONNAIRE INDIVIDUAL RESPONSES – TEST SUPPLEMENT .25APPENDIX 9: SELF-PERCEPTION QUESTIONNAIRE INDIVIDUAL – PLACEBO .28Final v2Page 3 of 30
PCR CORP REPORT: NUTUSE1M113th December 2016SUMMARYTitle:A single-blind, randomised home-use study, in 50 healthy maleand female volunteers, with self-assessed anxiety, to evaluatethe efficacy of one nutritional supplement compared toplacebo, as measured by Self-Perception Questionnaire (SPQ).Study design:Single blind, randomized home-use study.Test Articles:One active nutritional supplement and one placebo (Labelled):1. Nutritional Supplement A2. Nutritional Supplement BNumber of subjects: Fifty (50)Type of subjects:Healthy male and female volunteers, aged over 18 years, withself-assessed anxiety.Method:Subjects attended the test centre at baseline (Day 1) tocomplete the informed consent form (ICF). Subjects were issuedtheir supplement, diary and instructions. They were instructed onhow to take their supplement, complete their diary over the next30 Days, including the 2 Self-Perception Questionnaire (SPQ)questions daily, which are on their diary. At the end of the study(Day 30) subjects returned to the test centre to complete anonline Self-Perception Questionnaire (SPQ).Conclusion:As can be seen from the data the product performed highlyfavourably under Clearcast guidelines, over the 30 day testingperiod shown by Top 2 responses (Strongly Agree Agree) being 80% (regarded as highly favourable). The Sponsor’s productalso performed statistically significantly better than the Placeboproduct for all comparable questions. With 100% of subjectsnoticing an improvement in their level of anxiety and 68% ofsubjects feeling calmer after only 30 minutes.Duration of study:Study Started: w/c 5th September 2016Study Ended: w/e 7th October 2016Location:PCR Corp.8 Richmond RoadDukes ParkChelmsfordEssex CM2 6UAUnited KingdomFinal v2Page 4 of 30
PCR CORP REPORT: NUTUSE1M213th December 2016KEY STUDY PERSONNEL AND RESPONSIBILITIESKey personnelPrincipal Investigator (PI)Barrie DrewittPCR CorpPrinceton Forrestal Center307 College Road EastPrinceton, NJ 08540Tel: 609-455-1112Project Supervisor (PS)Andrew KingPCR Corp8 Richmond RoadDukes ParkChelmsfordEssex CM2 6UAUnited KingdomTel: 44 (0) 1245 934050Project Manager (PM)Jo BroydPCR Corp8 Richmond RoadDukes ParkChelmsfordEssex CM2 6UAUnited KingdomTel: 44 (0) 1245 934050Project Co-ordinator (PC)Dan WattersNutreance401 Riversville RoadGreenwichCT. 06831General responsibilitiesThe Principal Investigator (PI) will beresponsibleforensuringsufficientresources are available to conduct thestudy according to Good ClinicalPractice (GCP), for the study design,compiling the results and writing theclinical report.The Project Supervisor (PS) will beresponsible for the conduct of the studyon a daily basis.The Project Manager (PM) will beinvolved with the study design,compiling the results and writing theclinical report.The Project Co-ordinator (PC) will be theprimary point of contact on behalf of theSponsor of this project and will representthe Sponsor (Nutreance) of this study.Tel: 1 (800) 749-7776Email: support@nutreance.comFinal v2Page 5 of 30
PCR CORP REPORT: NUTUSE1M313th December 2016INTRODUCTION AND OBJECTIVESThe objective of this study was to evaluate the perceived efficacy of a nutritionalsupplement versus a placebo following continued home-use for four weeks viacompletion of a self-perception questionnaire (SPQ) at the end of the study. With theaim of supporting the following targeted claims proposed by sponsor:X% of subjects noticed an improvement in their level of anxietyX% of subjects felt calmer after only 30 minutesPlease note that it was the responsibility of the sponsor to determine the testing andstudy designs required for submission to entities such as the Home Shopping Network,QVC, etc.4STUDY DESIGNSingle-blind, randomised home-use study.5SELECTION OF SUBJECTS5.1ScreeningA sufficient number of subjects were screened into the study to allow for fifty subjectsto enter the active phase. Subjects satisfied the following inclusion and exclusioncriteria, and the subjects accepted the prohibitions and restrictions and gave writteninformed consent (Appendix 1 & 2).The suitability of potential subjects was confirmed before their acceptance onto thestudy by review of a study specific pre-treatment questionnaire (Appendix 3).5.25.3Inclusion criteriaa)Healthy male and female volunteers, aged over 18 years of age, with selfassessed anxiety.b)Subjects have completed a written informed consent.Exclusion criteriaFinal v2a)Subject is currently on prescription anti-anxiety medication or antidepressants.b)Subject is pregnant, nursing, or planning to become pregnant;c)A current skin disease of any type (e.g. eczema, psoriasis) apart from mildfacial acne.d)History of malignant disease.e)Significant past medical history of hepatic, renal, cardiac, pulmonary,digestive, haematological, neurological, locomotor or psychiatric disease.f)History of asthma requiring regular medication.g)Known sensitivity to the test article, similar materials or their constituents.h)Current participation in a clinical trial or follow-up.Page 6 of 30
PCR CORP REPORT: NUTUSE1M5.4613th December 2016Prohibitions and Requirementsa)Subjects agree to use the trial product assigned as instructed, instead oftheir usual brand for the duration of the study.b)Subjects who are vegetarian and vegan to be made aware of the gelatincontent in the pacebo capsule.TEST ARTICLESTo the best of the Sponsor’s knowledge and based on the information available, PCRCorp considered the test article to be safe for use in man.The following test article was supplied by the Sponsor labelled as follows:1. Supplement A2. Supplement BThe test articles and placebo were decanted into plain packaging plastic bags byPCR Corp. The Sponsor has provided ingredient listings for the test article (seeAppendix 4).It was the responsibility of the Sponsor to determine, for each batch of the test article,the identity, strength, purity, composition and other characteristics whichappropriately define the test article, before its use in the study. The determination ofits stability and documentation of methods of synthesis or derivation were also theSponsor's responsibility.It was the responsibility of the Sponsor that the test article meets all necessary transportregulations, particularly those regulations involving the carriage of hazardous goodsand the import/export of goods or equipment, and that any costs including tax/dutywere fully met by the Sponsor prior to receipt of the test article at PCR Corp. No liabilitywith regard to safe receipt or costs involved in the carriage of goods or equipment toany PCR Corp site was accepted.On study completion any remaining unused test articles were disposed of, unlessotherwise requested by the Sponsor, after issuance of the final report or 28 days afterstudy completion, whichever came first. Sponsors requesting the return of productswere liable for any costs incurred.7STUDY PROCEDUREa)Study OutlineSubjects attended the test centre at baseline (Day 1) to complete the informedconsent form (ICF). Subjects were issued with the test product (according toRandomisation; Appendix 5), diary (Appendix 6) and instructions for how to use theproduct at home for the next 4 weeks. Subjects completed 2 Self-PerceptionQuestionnaire (SPQ) questions daily, which were on their diary card. At the end of thestudy (Day 30) subjects returned to the test centre to complete an online SelfPerception Questionnaire (SPQ).b)Test Article UseThe test articles were used at home throughout the duration of the study. Accordingto the usage instructions (Appendix 2).Final v2Page 7 of 30
PCR CORP REPORT: NUTUSE1Mc)13th December 2016Self-Perception Questionnaire (SPQ)At the end of the study subjects completed an online SPQ (Appendix 7) on how thetest product improved their anxiety.8STUDY ETHICS8.1Declaration of HelsinkiThe study conformed to the requirements of the 1964 Declaration of Helsinki and itssubsequent amendments (World Medical Association; 2013).8.2Subject consentSubjects were informed of the nature, purpose and known risk of the study bothorally and in writing and gave their written informed consent to participate in thestudy prior to any study procedures being performed (Appendix 1). Subjects wereadvised that they were free to withdraw from the study at any time without beingobliged to give a reason. They were compensated for their time.8.3Indemnity ProvisionThe Sponsor was responsible, without regard to legal liability, and indemnified PCRCorp or any of their respective officers or employees in the event of claims forcompensation from subjects suffering injury or other deterioration in health orwell-being as a result of participation in this study, except and insofar as such claimsarise as a result of any negligent act or omission on the part of PCR Corp employeesor any persons undertaking or involved in the study by arrangement with PCR Corp.Final v2Page 8 of 30
PCR CORP REPORT: NUTUSE1M913th December 2016RESULTS9.1Location and dates of the studyThe study was performed at PCR Corp, between 5th September 2016 and 4th October2016.9.2SubjectsFifty (50) male and female subjects were enrolled onto the study and fifty (50) subjectscompleted the study.9.3Adverse events, adverse reactions and subjects not completing the studyNo Adverse Events were reported.9.4ConclusionsAs can be seen from the data the product performed highly favourably underClearcast guidelines, over the 30 day testing period shown by Top 2 responses(Strongly Agree Agree) being 80% (regarded as highly favourable). The Sponsor’sproduct also performed statistically significantly better than the Placebo product forall comparable questions. With 100% of subjects noticing an improvement intheir level of anxiety and 68% of subjects felt calmer after only 30 minutes.Bar Graphs over page show the percentage of subjects that gave the top tworesponses (Strongly Agrees Agrees) for the Active Supplement.Final v2Page 9 of 30
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PCR CORP REPORT: NUTUSE1M13th December 2016Table 1: Summary of % Responses for the Product agreeDisagreeStronglyDisagreeAfter taking this product I noticed animprovement in my level of anxiety.2872000After taking this product I felt calmerafter only 30 minutes.8602840After taking this product I felt calmer.2868400After taking this product I was able tosleep better.888400After taking this product I felt morerelaxed.2868400After taking this product I felt less worried.12682000After taking this product I felt I hadbetter concentration2476000After taking this product, my breathingwas more relaxed16681240After taking this product I had a morerestful sleep1280800After taking this product I felt I had moreenergy3264400After taking the product I felt more alertduring the day2476000After taking the product I felt I was ableto face my normal anxiety triggers8761240After taking the product I felt more atease with my daily routine2476000After taking the product I felt lessirritable2868400The supplement was easy to include inmy daily routine4852000The supplement was easy to swallow3664000I would recommend this product to afriend or family member.5644000Table 2: Statistical Analysis – Paired TTest of Treatment vs PlaceboQuestion No.12345678A vs B1.28E-03 2.52E-02 1.74E-04 1.10E-04 1.07E-03 1.19E-03 9.73E-04 2.21E-04Question No.910111213141516171819 20A vs B2.00E-04 2.41E-03 5.58E-05 9.73E-04 2.64E-04 1.22E-04 3.17E-02 2.00E-02 N/A 1.76E-04 N/A N/AP 0.05 shows that the subject’s perception of treatment product was statisticallysignificantly better than the subject’s perception of the placebo product.Final v2Page 12 of 30
PCR CORP REPORT: NUTUSE1M13th December 2016APPENDIX 1: SUBJECT CONSENT FORMStudy Code: NUTUSE1MSubject #:INTRODUCTIONYou are being asked for your consent to participate in a research study. Prior to giving yourconsent, it is important that you take the time to read and understand what participation willinvolve. This consent form may contain technical language which you may not understand. Ifyou do not understand any of this consent form, please ask the clinical staff any questions youmay have.You will be provided with a signed copy of this consent form and any other necessary writteninformation prior to the start of the study.OBJECTIVEThe objective of this research study is to determine the efficacy of one test article at reducinganxiety.TEST ARTICLESThe test article is a nutritional supplement. The test article used will be through normal everydayuse following usage instructions provided.STUDY PROCEDURESYou will be one of approximately 50 subjects enrolled onto this study. Your participation in thisstudy will last approximately four weeks (30 Days) and will include two visits to the testing facility.Visit 1 (Study day 1 – approximately 30 minutes): Prior to acceptance on the study, you will bescreened for eligibility to participate on the study and on confirmed eligibility consented toparticipate. Following verification of your acceptance and your written consent, you will beissued with the test product (with usage instructions and diary) to use at home for the next fourweeks. You will need to answer the 2 questions of your diary card every day.Visits 2 (Study day 30 – approximately 15 minutes): You will attend the study centre to completean online questionnaire, return any unused test product and receive compensation.RISKSTo the best of our knowledge, these products are not expected to induce an allergic reaction.While the potential for irritation or other reactions during this study are minimal, it is possible fora reaction to occur. Expected reactions for these test articles categories are mild in nature andmay include the following: redness, itching, peeling or blistering. In addition to the risksdescribed, there may be other risks that are currently unforeseeable.No significant adverse reactions are expected to occur. However, if you develop an adversereaction or complication as a result of your participation in this study, medical treatment willbe provided by clinical staff nurses at PCR CORP or you will be referred for appropriatetreatment at no cost to you, as long as you have followed the study instructions. Provisions ofsuch medical care is not an admission of legal responsibility. You will be followed by PCR CORPuntil the adverse reaction has resolved. No additional compensation will be available to you.Neither the sponsoring company nor the investigating company will be held responsible forany future medical expenses.Final v2Page 13 of 30
PCR CORP REPORT: NUTUSE1M13th December 2016APPENDIX 1 – CONTINUEDBENEFITSWhile it is likely that you will not receive any direct benefit from your participation in the study,the study results may have the potential to increase scientific knowledge about nutritionalsupplements and may allow for new and improved products to be marketed.CONFIDENTIALITYInformation concerning you that is obtained in connection with this study will be keptconfidential by PCR CORP, except that the sponsoring company whose product is beingtested will receive a copy of the study records. The records will be uniquely coded to protectyour and your child’s identity. In addition, third party regulatory authorities, including the U.S.Food and Drug Administration (FDA), may inspect the records of the study. In all cases, yourconfidentiality will be maintained and your identity will remain private.Your signature on the Informed Consent provides your permission for these agencies to viewyour personal information and the study data.NEW FINDINGSAny new information that is discovered during the study and which may influence yourwillingness to continue in the study will be made available to you.MEDICAL TREATMENTIn the event of an emergency, dial 999. If you receive any medical care during the course ofthe study, inform medical personnel that your participating in a research study. Please contactPCR CORP staff as soon as possible to inform them of your condition.WHO TO CONTACTIf you have any questions about this study or in the case of an emergency, contact Andy Kingon 01245 934050 during normal business hours.VOLUNTARY PARTICIPATION/WITHDRAWALYour participation in this research study is strictly voluntary. You may refuse to participate ormay discontinue participation at any time during the study without penalty or loss of benefitsto which you are otherwise entitled. However, you must contact the test facility and inform aclinical staff member of your decision to withdraw from the study.If you agree to participate in the study, you are also agreeing to provide PCR CORP withaccurate information and to follow study instructions as given to you. If you fail to follow studyinstructions, you may be asked to discontinue participation.Your participation in the study may be discontinued at any time without your consent by PCRCORP, regulatory agencies, or the sponsoring company for reasons of but not limited to asevere side effect and accompanying illness, or if you do not follow study instructions.COMPENSATIONIf you agree to your participation in this study, you will be paid XX upon completion of thestudy.Final v2Page 14 of 30
PCR CORP REPORT: NUTUSE1M13th December 2016APPENDIX 1 – CONTINUEDNON-DISCLOSUREAs a condition to your participation in the study you are asked not to discuss any informationregarding the products that you are testing, your experiences with the products, or youropinion of the products, nor share the products that you are testing with anyone outside of thetesting facility. By your signature on the Consent you are agreeing to abide by this conditionof participation.CONSENT TO PARTICIPATEI know that my participation in this study is voluntary and that I have the right to refuse toparticipate. I know that I may withdraw from the study at any time without penalty or loss ofbenefits to which I am otherwise entitled. If, at the discretion of the Investigator, it is best todiscontinue my participation for reasons other than a failure to obey the directions of the study,I will be paid in full or for the portion of the study we have completed once the study is over.CONSENTI have read all of the pages of this consent form and have been given an opportunity to askquestions about this study. Answers to such questions (if any) were satisfactory. I am at leasteighteen years old and without reservation give my consent to serve as a subject in this study.By signing this form, I have not given up any of my legal rights as a research subject. I will receivea copy of this signed consent document.You are making a decision whether or not to participate. Your signature indicates that youhave decided to participate, having read the information provided above.Subject’s Name Printed: FirstMiddle InitialLastSubject’s SignatureDateSignature of Person Conducting Consent DiscussionDateSubject NumberFinal v2Page 15 of 30
PCR CORP REPORT: NUTUSE1M13th December 2016APPENDIX 2: SUBJECT INFORMATION SHEET – NUTUSE1MStudy Code: NUTUSE1MYou have agreed to your participation in a research study. By agreeing to participate,you are also agreeing to the following prohibitions and restrictions:Subjects agree to use the trial product assigned as instructed, instead of theirusual brand for the duration of the study.The study schedule is as follows:Monday5th SeptTuesday – Sunday (Week 1)6th – 11th SeptVisit 1 –Use product at home, as instructed.Completioninformedconsent.ofAnswer 2 questions on diary card.Issue products,instructions anddiaryMonday – Sunday (Week 2)12th – 18th SeptUse product at home, as instructed.Answer 2 questions on diary card.Monday – Sunday (Week 3)19th – 25th SeptUse product at home, as instructed.Answer 2 questions on diary card.Monday – Monday (Week 4)26th – 3rd OctUse product at home, as instructed.Answer 2 questions on diary card.Tuesday4th OctVisit 2 –Study End SPQ CompletionProduct ReturnCompensationPlease follow the usage instructions below:Directions: Take 2 capsules in the morning, per day for 30 days which can be takenwith or without food. Please DO NOT open the capsules.*You must come in for all visits; no misses will be allowed. If you are unable to come infor a visit, your participation will be discontinued. Upon completion of this study on 4thOctober 2016, you will receive XX for your participation.If you have any questions about this study or in the case of a suspected allergicreaction, call Andy King on 01245 934050 during normal business hours.Final v2Page 16 of 30
PCR CORP REPORT: NUTUSE1M13th December 2016APPENDIX 3: PRE-TREATMENT QUESTIONNAIREFOR OFFICE USE ONLYSUBJECT’S INITIALSMALE/FEMALEAGESUBJECTNUMBERStudy Code: NUTUSE1MSTRICTLY CONFIDENTIALInclusion Criteria1.Healthy male and female volunteers, aged over 18 years,with self-assessed anxiety.2.Subject has completed a written informed consent.Exclusion Criteria1.Subject is pregnant, nursing, or planning to becomepregnant2.A current skin disease of any type at the test site (e.g.eczema, psoriasis)3.History of malignant disease4.Significant past medical history of hepatic, renal, cardiac,pulmonary, digestive, haematological, neurological,locomotor or psychiatric disease, which in the opinion ofthe Investigator would compromise the safety of thesubject;5.History of asthma requiring regular medication.6.Known sensitivity to the test article, similar materials or theirconstituents.7.Current participation in a clinical trial or follow-up.Prohibitions and Restrictions1.Final v2YesNoYesNoYesNoSubjects agree to use the trial product assigned asinstructed, instead of their usual brand for the duration ofthe study.Page 17 of 30
PCR CORP REPORT: NUTUSE1M13th December 2016APPENDIX 3 – CONTINUEDHave you ever had any skin problems related to the use of any of the following types of material?MaterialYesNoWhen? – Which products?– What happens?NutritionalSupplementsOtherPersonal CareProducts–please specifyQuestionnaire checked and confirmed by:SignatureFinal v2DatePage 18 of 30
PCR CORP REPORT: NUTUSE1M13th December 2016APPENDIX 4: TEST ARTICLES INCI LISTINGSActive SupplementIngredients:350 mg total of Redicalm proprietary blend: L-Theanine, Ashwagandha Powder,Lemon Balm Powder, Passion Flower Powder, 5 HTP.Other ingredients: Vegetable capsule (capsule shell), Rice Flour, MagnesiumStearate.Placebo SupplementIngredients:Gelatin capsule (capsule shell).Final v2Page 19 of 30
PCR CORP REPORT: NUTUSE1M13th December 2016APPENDIX 5: RANDOMISATIONFinal 46A21B47A22A48A23B49A24B50A25B51A26B52BPage 20 of 30
PCR CORP REPORT: NUTUSE1M13th December 2016APPENDIX 6: SUBJECT DIARYPlease take the test product supplied to you as instructed, 2 CAPSULES ONCE A DAY.Please answer the 2 questions in the table every day, following the answer key below.If you have any problems with the product please call the office at 01245 934050 during business hours,9:00am to 5:00pm.PLEASE USE BLACK INKDid you take 2 capsules?Check 7282930Final v2DateIf NO, explainwhyQ1 - AftertakingthisproductInoticedanimprovementin my level ofanxiety.Q2 - Aftertaking thisproductIfelt calmerafter only esNoYesNoPlease bring back the productand daily.Page 21 of 30
PCR CORP REPORT: NUTUSE1M13th December 2016Answer Key for the 2 questions:Strongly Disagree 1Disagree 2Neither Agree or Disagree 3Agree 4Strongly Agree 5Comments:Final v2Page 22 of 30
PCR CORP REPORT: NUTUSE1M13th December 2016APPENDIX 7: SELF-PERCEPTION QUESTIONNAIRENUTUSE1M: Self-Perception Questionnaire (Post-Treatment)Subject detailsInitials .Age .Q1 After taking this product I noticed animprovement in my level of anxiety.Q6 After taking this product I felt less worried.Strongly disagree .Disagree Disagree Neither agree nor disagree Neither agree nor disagree Agree .Agree .Strongly agree .Strongly disagree .Strongly agree .Q2 After taking this product I felt calmer after only 30minutes.Q7 After taking this product I felt I had betterconcentrationStrongly disagree .Strongly disagree .Disagree Disagree Neither agree nor disagree Neither agree nor disagree Agree .Agree .Strongly agree .Strongly agree .Q3 After taking this product I felt calmer.Strongly disagree .Q8 After taking this product, my breathing wasmore relaxedDisagree Strongly disagree .Neither agree nor disagree Disagree Agree .Neither agree nor disagree Strongly agree .Agree .Strongly agree .Q4 After taking this product I was able to sleep better.Strongly disagree .Q9 After taking this product I had a more restfulsleepDisagree Strongly disagree .Neither agree nor disagree Disagree Agree .Neither agree nor disagree Strongly agree
the efficacy of one nutritional supplement compared to placebo, as measured by Self-Perception Questionnaire (SPQ). Study design: Single blind, randomized home-use study. Test Articles: One active nutritional supplement and one placebo (Labelled): 1. Nutritional Supplement A 2. Nutritional Supplement B Number of subjects: Fifty (50)
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