Dietary Supplements and Personal Energy Tracking Device to Promote and Maintain Healthy Weight
Information source: Pharmanex
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Overweight; Obesity
Intervention: Dietary supplement containing vitamins, minerals, and herbs (Behavioral); Shakes with nutrients and herbs (Behavioral); Control dietary supplement (Behavioral); Isocaloric, isonitrogenous control shakes without herbs (Behavioral); Personal energy tracking tool (Behavioral)
Phase: N/A
Status: Completed
Sponsored by: Pharmanex Official(s) and/or principal investigator(s): Doug Burke, PhD, Principal Investigator, Affiliation: Pharmanex
Summary
Excessive body weight is becoming a concern around the world, for example over half of the
American adult population is overweight or obese. The purpose of this study is to determine
whether dietary supplements and shakes containing a combination of nutrients/ingredients
individually shown in research studies to reduce hunger, enhance metabolism, reduce the
body's ability to 'store' fat, and enhance energy, promote healthy body weight and
composition over 12 weeks. A further study objective is to determine whether the inclusion
of a personal, easy to use, energy tracking device for the measurement of daily energy
intake and expenditure also helps with the promotion of healthy body weight and body
composition.
In this prospective, blinded study 120 volunteers who meet the entrance criteria including a
BMI 25-35 kg/m2 and sign the informed consent form to participate in a 12 week long study
will be recruited. All subjects will consume a multi-vitamin, mineral and fish oil
supplement. Subjects will be randomly assigned to a control or experimental group and
stratified by BMI 25-30 and >30-35 kg/m2, age, and gender with an equal number of subjects
in each strata across groups. A subset of subjects will also wear a personal energy
tracking device. Subjects will be instructed how to incorporate the shakes and supplements
into their current diet and encouraged to incorporate fruits, vegetables, whole grains, and
other healthy foods into their current meals and to exercise at least 30 minutes five days
per week.
Clinical Details
Official title: Evaluation of Dietary Supplements (Shakes and Supplements) and Personal Energy Tracking Device to Promote and Maintain Healthy Weight
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind
Primary outcome: Body weight changes
Secondary outcome: Biophotonic scanner score, blood chemistry and metabolic profiles, adverse events, subjects' supplement preference, quality of life measurements
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Between the ages of 18-65 years of age.
- Body Mass Index (BMI) between 25-35
- Willing to stop taking any nutritional supplements
Exclusion Criteria:
- Currently taking weight loss medication or supplements
- Currently smoke
- Taking any prescription medications
- Experienced at least a 10 pound weight loss over the past 2 months.
- History of serious heart problems (i. e. heart attack, angina, bypass surgery).
- Diagnosed with diabetes (insulin or non-insulin dependent)
- Known history of gastrointestinal diseases (i. e. Crohn's disease, chronic diarrhea,
Inflammatory Bowel Disease)
- Undergone surgical procedure for weight loss (i. e. gastroplasty, gastric by-pass,
gastrectomy, stomach stapling, gastric banding, etc).
- History of stroke or seizure activity
- Medical conditions known to affect serum lipids
- History of uncontrolled hypertension or with a current measured blood pressure with
diastolic above 90 or systolic above 140 mm Hg
- A total serum cholesterol above 240 mg/dL
- Known HIV infection
- Known history of depression and currently taking anti-depression medications
- Treated for cancer in the last 5 years
- Known allergies to supplements
- Known history of eating disorder (i. e. bulimia, anorexia nervosa)
- Known severe swallowing disorders
- For females, known to be pregnant or breast-feeding or trying to become pregnant
- Participating in another clinical (medical or nutritional) study or likely to be
enrolled in another medical or nutritional protocol during this study
Locations and Contacts
Pharmanex, Provo, Utah 84601, United States
Additional Information
Starting date: July 2007
Last updated: March 26, 2008
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