A Study to Evaluate the Effect of a Study Product on Quality of Life and Mood

Safety and Efficacy Profile of the Eurycomalongifoliawaterextract (Physta®)+Multivitamin Study Product

A phase II randomized, placebo controlled study evaluating the efficacy of Eurycomalongifoliawater extract (Physta®)+Multivitamin on quality of life and mood on 86 healthy adults over a 24 week supplementation period.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Mood
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Eurycomalongifoliawater extract (Physta®); Dietary supplement: Multivitamin

• Study Type: Interventional
• Enrollment (Actual): 86
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy subjects ≥ 25 and ≤ 65 years of age.
• Body mass index (BMI) ≥ 18 and ≤30 kg/m2.
• Subjects must be employed in a job/position that has some degree of responsibility such that they experience a mid-level of stress at work.
• Subjects with a score of ≤ 18 in the Tension subscale and a score of ≤ 14 in the Fatigue subscale of the POMS Questionnaire.
• Judged by the Investigator to be in general good health on the basis of medical history.
• Females of child-bearing potential must agree to use appropriate birth control methods during the study.
• Understands the study procedures and signs forms providing informed consent to participate in the study and authorization for release of relevant protected health information to the study investigator
• Understands the study procedures and signs forms providing informed consent to participate in the study and authorization for release of relevant protected health information to the study investigator

Exclusion Criteria:

• Subjects with any history of immune system disorder or auto-immune disorder including but not limited to the following:

  *AIDS, HIV, Ankylosing Spondylitis, Chronic Fatigue Syndrome, CREST syndrome, Crohn's disease, Dermatomyositis, Fibromyalgia, Grave's disease, Hashimoto's Thyroiditis, Lupus, Multiple Sclerosis, Myasthenia Gravis, Pernicious Anemia, PolyarteritisNodosa, Primary Biliary Cirrhosis, Psoriasis, Reynaud's Syndrome, Rhematoid Arthritis, Sarcoidosis, Scleroderma, Sjogren's Syndrome, Temporal Arthritis, Ulcerative Colitis, and Vitiligo

• Use of any immunosuppressive drugs in the last 12 months (including steroids or biologics)
• Any significant GI condition that would severely interfere with the evaluation of the study product including but not limited to inflammatory bowel disease (Ulcerative Colitis or Chron's), history of frequent diarrhea, history of surgery for weight loss (including gastric bypass or lapband), history of perforation of the stomach or intestines, gastroparesis, clinically important lactose intolerance
• Any active infection, or infection in the last month requiring antibiotics, antiviral medication, or hospitalization History or presence of cancer in the prior two years, except for non-melanoma skin cancer.
• Subjects with a history of seizure
• Recent history of (within 12 months) or strong potential for alcohol or substance abuse.
• Participation in a clinical study with exposure to any non-registered drug product within 30 days prior.
• Subject who are using herbal products containing androgenic/anxiolytic activity within 30 days (one month washout is allowed)
• Individual has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk. Including subjects who are Bed or wheelchair-bound
• Untreated or unstable Hypothyroidism
• Subjects with active eating disorder including anorexia nervosa, bulimia, and/or obsessive compulsive eating disorders
• Central Neurological disorders including but not limited to Spinal cord injuries, multiple sclerosis, Parkinson's disease
• Pregnant, lactating, planning to become pregnant or unwilling to use adequate contraception during the duration of the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Dietary supplement: Placebo
Experimental: Eurycomalongifoliawater extract (Physta®) +Multivitamin	Dietary supplement: Eurycomalongifoliawater extract (Physta®); Dietary supplement: Multivitamin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The change in quality of life after 24 weeks of supplementation with study product, measured using the SF-12 Quality of Life Questionnaire	24 Week
The change in mood after 24 weeks of supplementation with study product, measured using the POMS Questionnaire	24 week

Secondary Outcome Measures

Outcome Measure	Time Frame
The change in stress after 24 weeks of supplementation with study product, measured using the Multi-Modal Stress Questionnaire	24 weeks
The change in fasting AM Cortisol levels after 24 weeks of supplementation with study product.	24 weeks

Other Outcome Measures

Outcome Measure	Time Frame
The change in CBC levels after 24 weeks of supplementation with study product	24 weeks
The change in CMP results after 24 weeks of supplementation with study product	24 weeks
The change in urinalysis results after 24 weeks of supplementation with study product	24 weeks
The number of adverse events reported after 24 weeks of supplementation with study product	24 weeks
The change in lipid panel results after 24 weeks of supplementation with study product	24 weeks
The change in total testosterone results after 24 weeks of supplementation with study product	24 weeks
The change in free testosterone results after 24 weeks of supplementation with study product	24 weeks

Collaborators and Investigators

• Sponsor: KGK Science Inc.
• Collaborators: Biotropics Malaysia Berhad
• Investigators: Study Director: TengkuShahrirTengku Adnan, Biotropics Malaysia Berhad

Publications and helpful links

General Publications

• George A, Udani J, Abidin NZ, Yusof A. Efficacy and safety of Eurycoma longifolia (Physta(R)) water extract plus multivitamins on quality of life, mood and stress: a randomized placebo-controlled and parallel study. Food Nutr Res. 2018 Oct 16;62. doi: 10.29219/fnr.v62.1374. eCollection 2018.

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: August 10, 2016
• First Submitted That Met QC Criteria: August 12, 2016
• First Posted (Estimate): August 15, 2016

Study Record Updates

• Last Update Posted (Actual): February 27, 2019
• Last Update Submitted That Met QC Criteria: February 25, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Quality of Life; Mood; Multivitamin; Eurycomalongifoliawater extract
• Other Study ID Numbers: BIOT2600