The Effects of Formula Diet on Body Weight, Body Composition, and Biomarkers for Disease Compared to a Standard Diet
| Status: | Completed |
|---|---|
| Conditions: | Obesity Weight Loss |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 4/21/2016 |
| Start Date: | April 2005 |
| End Date: | May 2006 |
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.
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.
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.
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.
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)
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