Effects of a Nutritional Supplement Combination on Body Weight Management

Completed · Phase 4

Conditions studied: Safety/Effacy

In brief

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

Key facts

Study ID

NCT01725958

Run by

Pharmanex

People needed

60

Starts

2012-09-01

Expected to finish

2014-10-01

Last updated by the study team

2014-10-29

Who can join

Age: 25 and older, up to 65. Sex: any. Healthy volunteers: accepted.

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.

Where it is running

• Aspen Clinical Research — Orem, Utah, United States

Full record on ClinicalTrials.gov

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