Status:
COMPLETED
The Effects of Formula Diet on Body Weight, Body Composition, and Biomarkers for Disease Compared to a Standard Diet
Lead Sponsor:
Pennington Biomedical Research Center
Collaborating Sponsors:
Sunny Health Co., Ltd.
Conditions:
Body Weight Changes
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
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 is...
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, hypertensio...
Eligibility Criteria
Inclusion
- 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
- \> 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)
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2006
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00138645
Start Date
April 1 2005
End Date
May 1 2006
Last Update
February 8 2016
Active Locations (1)
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1
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808