Effects of a Nutritional Supplement Combination on Body Weight Management

NCT01725958 | Completed Phase 4 DMC

• 1 other identifier: NSE 12-PHX-08-NU-02
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Safety/Effacy

Outcome Measures

Primary Outcomes (1)

• -Evaluate the changes in body composition as determined by percent body fat using the Bod Pod

  90 Days

Secondary Outcomes (1)

• Evaluate the changes in body weight

  90 days

Study Arms (1)

Dietary Supplement

EXPERIMENTAL

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.

Dietary Supplement: Nutritional supplement and protein shakes

Interventions

Nutritional supplement and protein shakes DIETARY_SUPPLEMENT

Dietary Supplement

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Females and Males aged 25-65 years
• Signed informed consent
• BMI between 25 and 40 kg/m2
• 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
• 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
• Ability to speak and understand English
• Willing to fast the morning of visit where blood samples are taken

You may not qualify if:

• Self-reported chronic condition that may affect subject safety (e.g., diabetes, cardiovascular disease) or significantly impact product effectiveness (e.g., chronic fatigue)
• Pregnancy/suspected pregnancy, breastfeeding or planning to become pregnant during the course of the study.
• Use of Antihypertensive medication for less than 4 months or unregulated clinically blood pressure.
• Having undergone gastroplasty or bariatric surgery in the past 10 years.
• Taking medication (e.g., thyroid medication), must be stable for at least four months.
• Allergies to any ingredients contained in the Nutritional Supplement.
• Medical treatment for insomnia or depression within 30-days prior to the screening visit.
• Tobacco (e.g. cigarettes, chewing tobacco, pipe, nicotine patches) use within 30-days prior to the screening visit.
• Planned surgical procedure during the course of the study.
• 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.
• Currently taking any medication or supplement for the use of weight loss must be discontinued prior to Visit 1 Baseline Day 0.
• Currently participating in a weight loss program or participated in a weight loss program in the past 6 months.

Sponsors & Collaborators

• Pharmanex: lead
• Nu Skin Enterprises: collaborator

Study Sites (1)

Aspen Clinical Research

Orem, Utah, 84058, United States

Location

MeSH Terms

Interventions

Dietary Supplements

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Steve Poole, BS

  Pharmanex

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2012
• First Posted: November 14, 2012
• Study Start: September 1, 2012
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: October 29, 2014

Record last verified: 2012-11

Locations

US (1)