Dietary Supplements and Personal Energy Tracking Device to Promote and Maintain Healthy Weight
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.
|Overweight Obesity||Behavioral: 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|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
|Official Title:||Evaluation of Dietary Supplements (Shakes and Supplements) and Personal Energy Tracking Device to Promote and Maintain Healthy Weight|
- Body weight changes [ Time Frame: Several measurements over 12 weeks ]
- Biophotonic scanner score, blood chemistry and metabolic profiles, adverse events, subjects' supplement preference, quality of life measurements [ Time Frame: Several measurements over 12 weeks ]
|Study Start Date:||July 2007|
|Study Completion Date:||December 2007|
|Primary Completion Date:||December 2007 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00502658
|United States, Utah|
|Provo, Utah, United States, 84601|
|Principal Investigator:||Doug Burke, PhD||Pharmanex|