NCT00502658

Dietary Supplements and Personal Energy Tracking Device to Promote and Maintain Healthy Weight

Evaluation of Dietary Supplements (Shakes and Supplements) and Personal Energy Tracking Device to Promote and Maintain Healthy Weight

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Pharmanex · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Overweight
• Obesity

Interventions

Type	Name	Description
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

Timeline

• Start date: 2007-07-01
• Primary completion: 2007-12-01
• Completion: 2007-12-01
• First posted: 2007-07-17
• Last updated: 2008-03-28

Locations

1 site across 1 country: United States