Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Collaborator:
Sunny Health Co., Ltd.
Information provided by:
Pennington Biomedical Research Center
ClinicalTrials.gov Identifier:
NCT00138645
First received: August 29, 2005
Last updated: April 21, 2009
Last verified: April 2009
  Purpose

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.


Condition Intervention Phase
Body Weight Changes
Behavioral: Formula Diet
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: The Effects of Formula Diet on Body Weight, Body Composition, and Biomarkers for Disease Compared to a Standard Diet

Resource links provided by NLM:


Further study details as provided by Pennington Biomedical Research Center:

Primary Outcome Measures:
  • Body Weight Loss (kg and Percent) at Months 3 and 6 [ Time Frame: April 2005 to May 2006 ] [ Designated as safety issue: No ]
  • Percent Change in Body Weight (Completers). [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Body Composition at Months 3 and 6 [ Time Frame: April 2005 to May 2006 ] [ Designated as safety issue: No ]
  • Disease Biomarkers (Cholesterol, Triglycerides, Etc.) at Months 3 and 6 [ Time Frame: April 2005 to May 2006 ] [ Designated as safety issue: No ]
  • Subjective Ratings of Appetite at Week 2 and Months 1, 2, 3, 4, 5, and 6 [ Time Frame: April 2005 to May 2006 ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: April 2005
Study Completion Date: May 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Forumula Diet
Behavioral: Formula Diet
Formula diet vs. dietary counseling.
Active Comparator: 2
Nutrition counseling.
Behavioral: Formula Diet
Formula diet vs. dietary counseling.

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00138645

Locations
United States, Louisiana
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808
Sponsors and Collaborators
Pennington Biomedical Research Center
Sunny Health Co., Ltd.
Investigators
Principal Investigator: Corby K. Martin, Ph.D. Pennington Biomedical Research Center
  More Information

No publications provided

Responsible Party: Corby Martin, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT00138645     History of Changes
Other Study ID Numbers: Formula diet, Formula Diet
Study First Received: August 29, 2005
Results First Received: April 21, 2009
Last Updated: April 21, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Body Weight
Body Weight Changes
Signs and Symptoms

ClinicalTrials.gov processed this record on November 20, 2014