Clinical trial NCT00138645: The Effects of Formula Diet on Body Weight, Body Composition, and Biomarkers for Disease Compared to a Standard Diet
Official title: The Effects of Formula Diet on Body Weight, Body Composition, and Biomarkers for Disease Compared to a Standard Diet
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Body Weight Changes
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
Collaborators: name: Sunny Health Co., Ltd.
First posted: 2005-08-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: It is hypothesized that the use of a partial supplement diet, which includes the use of meal replacements, will result in significantly greater weight loss after three and six months compared to an isocaloric diet that does not include supplements. It is also hypothesized that the partial supplement diet will result in larger improvements in body composition, disease biomarkers, and health parameters (blood pressure, lipids) compared to the non-supplement diet. Finally, it is hypothesized that subjective ratings of satiety will be significantly higher, and ratings of hunger lower, in the group consuming a partial supplement diet.

Detailed description: In recent decades, the prevalence of overweight and obesity has increased dramatically in developed countries. Obesity is associated with diseases such as diabetes, cardiovascular disease, hypertension, and certain cancers. Modest amounts of weight loss (e.g., 5% to 10% of initial body weight) significantly improve health and improve disease status. Recent evidence suggests that the use of supplements or meal replacements promotes greater weight loss than isocaloric food-based diets. In addition, diets that are high in protein are associated with greater ratings of satiety and reduced food intake, as well as greater weight loss, compared to lower protein diets.

The purpose of the proposed study is to test the effect of a partial supplement diet on body weight, body composition, and biomarkers for disease compared to an isocaloric diet that consists of a traditional food-based meal plan. Overweight and obese (BMI 25 to 35) participants will participate in this six-month study. The primary outcome variable is body weight loss and the secondary outcome variables include body composition, blood pressure, lipids, and subjective ratings of satiety.

Eligibility criteria: Inclusion Criteria:

* Male or female gender; of all ethnic backgrounds.
* Healthy person who has not been diagnosed with diabetes, cardiovascular illness, renal, hepatic or other chronic diseases
* \> 17 years and \< 66 years of age
* Body mass index (BMI; kg/m2) between 25 and 35
* For females with the potential to bear children, they meet one of the following criteria:

  * They are willing to use an acceptable method of birth control (e.g., oral contraceptive tablets, implanted contraceptive hormones, Depo-Provera® contraceptive injections, intrauterine devices, prophylactic condoms with spermicide, contraceptive diaphragms with spermicide, cervical caps with spermicide), or are in a monogamous relationship with a partner who has had a vasectomy.
  * They are sexually abstinent and intend to continue this practice, at least for the duration of the study.

Exclusion Criteria:

* \> 65 years and \< 18 years of age
* Regular use of medications other than birth control, vitamins or hormone replacement therapy
* Diabetes mellitus (fasting blood sugar \[FBS\] \> 126); persons with impaired glucose tolerance (FBS 100-125) may be admitted to the study.
* Use of tobacco products
* Depression or mental illness requiring treatment or medication within the last six months
* For women, pregnancy, breast feeding, postpartum \< 6 months, planning a pregnancy during the study, or are not using an acceptable method of contraception
* Use of medications or herbal supplements that affect appetite or body weight for the previous three months
* Patients requiring restriction of protein intake
* Impaired kidney function (creatinine \> 1.5) or liver function (liver enzymes \> 3 times the upper limits of normal)

Primary outcomes:
measure: Body Weight Loss (kg and Percent) at Months 3 and 6
timeFrame: April 2005 to May 2006
measure: Percent Change in Body Weight (Completers).
timeFrame: 24 weeks
Secondary outcomes:
measure: Change in Body Composition at Months 3 and 6
timeFrame: April 2005 to May 2006
measure: Disease Biomarkers (Cholesterol, Triglycerides, Etc.) at Months 3 and 6
timeFrame: April 2005 to May 2006
measure: Subjective Ratings of Appetite at Week 2 and Months 1, 2, 3, 4, 5, and 6
timeFrame: April 2005 to May 2006
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
affiliation: Pennington Biomedical Research Center
name: Corby K. Martin, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: