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

Sponsor

Pharmanex (Industry)

Overall Status

Completed

CT.gov ID

NCT00502658

Collaborator

(none)

120

Enrollment

Location

Duration (Months)

23.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
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	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single

Official Title:

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

Study Start Date :

Jul 1, 2007

Actual Primary Completion Date :

Dec 1, 2007

Actual Study Completion Date :

Dec 1, 2007

Outcome Measures

Primary Outcome Measures

Body weight changes [Several measurements over 12 weeks]

Secondary Outcome Measures

Biophotonic scanner score, blood chemistry and metabolic profiles, adverse events, subjects' supplement preference, quality of life measurements [Several measurements over 12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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