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

This study has been completed.
Sponsor:
Information provided by:
Pharmanex
ClinicalTrials.gov Identifier:
NCT00502658
First received: July 12, 2007
Last updated: March 26, 2008
Last verified: March 2008
  Purpose

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 Intervention
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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Official Title: Evaluation of Dietary Supplements (Shakes and Supplements) and Personal Energy Tracking Device to Promote and Maintain Healthy Weight

Resource links provided by NLM:


Further study details as provided by Pharmanex:

Primary Outcome Measures:
  • Body weight changes [ Time Frame: 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 [ Time Frame: Several measurements over 12 weeks ]

Estimated Enrollment: 120
Study Start Date: July 2007
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00502658

Locations
United States, Utah
Pharmanex
Provo, Utah, United States, 84601
Sponsors and Collaborators
Pharmanex
Investigators
Principal Investigator: Doug Burke, PhD Pharmanex
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00502658     History of Changes
Other Study ID Numbers: 007-001, WIRB 20070167
Study First Received: July 12, 2007
Last Updated: March 26, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Pharmanex:
Overweight
Obese
Dietary Supplements
Shakes
Nutrition
Overweight and Obese Adults (BMI 25-35)

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on September 22, 2014