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NCT Number: NCT00502658

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

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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pharmanex

Provo, Utah, 84601, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Body weight changes

    Time frame: 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

    Time frame: Several measurements over 12 weeks

Sponsors and collaborators

Lead sponsor

Pharmanex

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Jul 17, 2007
Registry last updated
Mar 28, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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