The Effects of Formula Diet on Body Weight, Body Composition, and Biomarkers for Disease Compared to a Standard Diet

Body Weight Changes Clinical Trial

— FORMULA  

Official title:

The Effects of Formula Diet on Body Weight, Body Composition, and Biomarkers for Disease Compared to a Standard Diet

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00138645
• Other study ID #: PBRC 25004
• Status: Completed
• Phase: Phase 4
• First received: August 29, 2005
• Last updated: January 15, 2016
• Start date: April 2005
• Est. completion date: May 2006

Study information

• Verified date: January 2016
• Source: Pennington Biomedical Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 2006
• Est. primary completion date: May 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Body Weight
• Body Weight Changes

Intervention

Behavioral:
• MicroDiet
MicroDiet
• Healthy Diet
Participants randomized to the Healthy Diet group will be prescribed a traditional food-based diet that contains the same number of kilocalories (1200/day) as the MicroDiet but will be instructed not to use meal replacements

Locations

Country	Name	City	State
United States	Pennington Biomedical Research Center	Baton Rouge	Louisiana

Sponsors (2)

Lead Sponsor	Collaborator
Pennington Biomedical Research Center	Sunny Health Co., Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body Weight Loss (kg and Percent) at Months 3 and 6		April 2005 to May 2006	No
Primary	Percent Change in Body Weight (Completers).	Percent change in body weight from baseline to week 24(completers).	24 weeks	No
Secondary	Change in Body Composition at Months 3 and 6		April 2005 to May 2006	No
Secondary	Disease Biomarkers (Cholesterol, Triglycerides, Etc.) at Months 3 and 6		April 2005 to May 2006	No
Secondary	Subjective Ratings of Appetite at Week 2 and Months 1, 2, 3, 4, 5, and 6		April 2005 to May 2006	No