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

This study has been completed.

Sponsors and Collaborators: Pennington Biomedical Research Center
Sunny Health Co., Ltd.
Information provided by: Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT00138645

Purpose

It is hypothesized that 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.
Condition Intervention Phase
Body Weight Change
 Behavior: Formula Diet
Phase IV

MedlinePlus consumer health information 

Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study

Further Study Details: 
Primary Outcomes: Body weight loss (kg and percent) at Months 3 and 6.
Secondary Outcomes: Change in body composition at Months 3 and 6.; Disease biomarkers (cholesterol, triglycerides, etc.) at Months 3 and 6.; Subjective ratings of appetite at week 2 and months 1, 2, 3, 4, 5, and 6.
Expected Total Enrollment:  60

Study start: April 2005

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

Ages Eligible for Study:  18 Years   -   65 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

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, you meet one of the following criteria:

    1. You 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.
    2. You 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 (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, or 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).

Location Information


Louisiana
      Pennington Biomedical Research Center, Baton Rouge,  Louisiana,  70808,  United States

Study chairs or principal investigators

Corby K. Martin, Ph.D.,  Principal Investigator,  Pennington Biomedical Research Center   

More Information

Study ID Numbers:  Formula diet
Last Updated:  August 29, 2005
Record first received:  August 29, 2005
ClinicalTrials.gov Identifier:  NCT00138645
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-08-30



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