This trial is active, not recruiting.

Condition safety/effacy
Treatment nutritional supplement and protein shakes
Phase phase 4
Sponsor Pharmanex
Collaborator Nu Skin Enterprises
Start date September 2012
End date December 2012
Trial size 60 participants
Trial identifier NCT01725958, NSE 12-PHX-08-NU-02


Title: A Phase IV, Open-label, Single-Center Study on the Effects of a Nutritional Supplement Combination on Body Weight Management over a 90-day period

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Treatment Regimen -The Nutritional Supplement will be given for approximately 90 days in the form of 7 capsules and a powder to mix into liquids or foods for the first 15 days of program. Subjects will also drink a protein shake.
nutritional supplement and protein shakes

Primary Outcomes

-Evaluate the changes in body composition as determined by percent body fat using the Bod Pod
time frame: 90 Days

Secondary Outcomes

Evaluate the changes in body weight
time frame: 90 days

Eligibility Criteria

Male or female participants from 25 years up to 65 years old.

Inclusion Criteria: 1. Females and Males aged 25-65 years 2. Signed informed consent 3. BMI between 25 and 40 kg/m2 4. A resting normotensive blood pressure is defined as a systolic blood pressure between 90-145 mmHg and a diastolic blood pressure of 50 90 mmHg 5. Use of effective method of contraception by females of childbearing [potential and agreement to continue to practice an acceptable method of contraception for the duration of their participation in the study]. Acceptable methods of contraception include oral, injectable, or implantable contraceptives; intrauterine devices, diaphragm plus spermicide; abstinence (must agree to use double-barrier method if they become sexually active), transdermal patch, or any double barrier method including a vasectomized sexual partner. Women who have had a hysterectomy or tubal ligation at least 6 months prior to Visit 1 or who have been post-menopausal 6. Ability to speak and understand English 7. Willing to fast the morning of visit where blood samples are taken Exclusion Criteria: 1. Self-reported chronic condition that may affect subject safety (e.g., diabetes, cardiovascular disease) or significantly impact product effectiveness (e.g., chronic fatigue) 2. Pregnancy/suspected pregnancy, breastfeeding or planning to become pregnant during the course of the study. 3. Use of Antihypertensive medication for less than 4 months or unregulated clinically blood pressure. 4. Having undergone gastroplasty or bariatric surgery in the past 10 years. 5. Taking medication (e.g., thyroid medication), must be stable for at least four months. 6. Allergies to any ingredients contained in the Nutritional Supplement. 7. Medical treatment for insomnia or depression within 30-days prior to the screening visit. 8. Tobacco (e.g. cigarettes, chewing tobacco, pipe, nicotine patches) use within 30-days prior to the screening visit. 9. Planned surgical procedure during the course of the study. 10. Currently participating in another study or have done so within 30 days prior to the screening visit or is likely to enroll in another clinical or nutritional study. 11. Currently taking any medication or supplement for the use of weight loss must be discontinued prior to Visit 1 Baseline Day 0. 12. Currently participating in a weight loss program or participated in a weight loss program in the past 6 months.

Additional Information

Official title A Phase IV, Open-label, Parallel Group, Single-Center Study on the Effects of a Nutritional Supplement Combination on Body Weight Management Over a 90-day Period
Description Safety assessment: Safety will be assessed by changes in blood chemistries/hematology, and adverse events, of nutritional supplement emergent AEs (TEAEs), classified by severity grade, relatedness to the nutritional supplement. Efficacy Assessment: The objectives of this study are to evaluate the efficacy (changes in body composition and measurements as well as influence on appetite and quality of life changes) of the nutritional supplement administered repeatedly throughout the study. Study Subject Population: Healthy adult men and women are eligible for participation upon fulfillment of the inclusion/exclusion criteria.
Trial information was received from ClinicalTrials.gov and was last updated in November 2012.
Information provided to ClinicalTrials.gov by Pharmanex.