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

NCT00502658 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2008-03-28

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Pharmanex

    lead INDUSTRY

Principal Investigators

  • Doug Burke, PhD · Pharmanex

Study Design

Allocation
RANDOMIZED
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2007-12-31
Completion
2007-12-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00502658 on ClinicalTrials.gov