Obesity, Overweight
Conditions
Keywords
Overweight, Obese, Dietary Supplements, Shakes, Nutrition, Overweight and Obese Adults (BMI 25-35)
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.
Interventions
BEHAVIORALDietary supplement containing vitamins, minerals, and herbs
BEHAVIORALShakes with nutrients and herbs
BEHAVIORALControl dietary supplement
BEHAVIORALIsocaloric, isonitrogenous control shakes without herbs
BEHAVIORALPersonal energy tracking tool
Sponsors
Pharmanex
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Body weight changes | Several measurements over 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Biophotonic scanner score, blood chemistry and metabolic profiles, adverse events, subjects' supplement preference, quality of life measurements | Several measurements over 12 weeks |
Countries
United States
Outcome results
None listed