Clinical trial NCT00502658: Dietary Supplements and Personal Energy Tracking Device to Promote and Maintain Healthy Weight
Official title: Evaluation of Dietary Supplements (Shakes and Supplements) and Personal Energy Tracking Device to Promote and Maintain Healthy Weight
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Obesity
Keywords: Overweight
Obese
Dietary Supplements
Shakes
Nutrition
Overweight and Obese Adults (BMI 25-35)
Lead sponsor: Pharmanex
Sponsor class: INDUSTRY
First posted: 2007-07-17
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.


Eligibility 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

Primary outcomes:
measure: Body weight changes
timeFrame: Several measurements over 12 weeks
Secondary outcomes:
measure: Biophotonic scanner score, blood chemistry and metabolic profiles, adverse events, subjects' supplement preference, quality of life measurements
timeFrame: Several measurements over 12 weeks
Other outcomes:
Locations:
city: Provo
country: United States
facility: Pharmanex
state: Utah
Study officials:
affiliation: Pharmanex
name: Doug Burke, PhD
role: PRINCIPAL_INVESTIGATOR
References: