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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00502658
• Other study ID #: 007-001, WIRB 20070167
• Status: Completed
• Phase: N/A
• First received: July 12, 2007
• Last updated: March 26, 2008
• Start date: July 2007
• Est. completion date: December 2007

Study information

• Verified date: March 2008
• Source: Pharmanex
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Behavioral:
• Dietary supplement containing vitamins, minerals, and herbs

• Shakes with nutrients and herbs

• Control dietary supplement

• Isocaloric, isonitrogenous control shakes without herbs

• Personal energy tracking tool

Locations

Country	Name	City	State
United States	Pharmanex	Provo	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Pharmanex

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body weight changes		Several measurements over 12 weeks
Secondary	Biophotonic scanner score, blood chemistry and metabolic profiles, adverse events, subjects' supplement preference, quality of life measurements		Several measurements over 12 weeks