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

NCT00502658 | Completed

• 1 other identifier: 007-001, WIRB 20070167
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight; Obesity

Keywords

Overweight; Obese; Dietary Supplements; Shakes; Nutrition; Overweight and Obese Adults (BMI 25-35)

Outcome Measures

Primary Outcomes (1)

• Body weight changes

  Several measurements over 12 weeks

Secondary Outcomes (1)

• Biophotonic scanner score, blood chemistry and metabolic profiles, adverse events, subjects' supplement preference, quality of life measurements

  Several measurements over 12 weeks

Interventions

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 BEHAVIORAL

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Between the ages of 18-65 years of age.
• Body Mass Index (BMI) between 25-35
• Willing to stop taking any nutritional supplements

You may not qualify if:

• 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

Sponsors & Collaborators

• Pharmanex: lead

Study Sites (1)

Pharmanex

Provo, Utah, 84601, United States

Location

MeSH Terms

Conditions

Overweight; Obesity; Tremor

Interventions

Minerals; Nutrients

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Dyskinesias; Neurologic Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Inorganic Chemicals; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Doug Burke, PhD

  Pharmanex

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 12, 2007
• First Posted: July 17, 2007
• Study Start: July 1, 2007
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: March 28, 2008

Record last verified: 2008-03

Locations

US (1)