Body Weight Changes
Conditions
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 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.
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.
Interventions
BEHAVIORALMicroDiet
MicroDiet
BEHAVIORALHealthy 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
Sponsors
Sunny Health Co., Ltd.
Pennington Biomedical Research Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body Weight Loss (kg and Percent) at Months 3 and 6 | April 2005 to May 2006 | — |
| Percent Change in Body Weight (Completers). | 24 weeks | Percent change in body weight from baseline to week 24(completers). |
Secondary
| Measure | Time frame |
|---|---|
| Change in Body Composition at Months 3 and 6 | April 2005 to May 2006 |
| Disease Biomarkers (Cholesterol, Triglycerides, Etc.) at Months 3 and 6 | April 2005 to May 2006 |
| Subjective Ratings of Appetite at Week 2 and Months 1, 2, 3, 4, 5, and 6 | April 2005 to May 2006 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| MicroDiet MicroDiet | 30 |
| Healthy Diet Healthy Diet | 30 |
| Total | 60 |
Baseline characteristics
| Characteristic | Healthy Diet | MicroDiet | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 30 Participants | 30 Participants | 60 Participants |
| Age, Continuous | 43 years STANDARD_DEVIATION 11.4 | 40 years STANDARD_DEVIATION 11.4 | 42 years STANDARD_DEVIATION 11.4 |
| Region of Enrollment United States | 30 participants | 30 participants | 60 participants |
| Sex: Female, Male Female | 25 Participants | 26 Participants | 51 Participants |
| Sex: Female, Male Male | 5 Participants | 4 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
Primary
Body Weight Loss (kg and Percent) at Months 3 and 6
Time frame: April 2005 to May 2006
Primary
Percent Change in Body Weight (Completers).
Percent change in body weight from baseline to week 24(completers).
Time frame: 24 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| MicroDiet | Percent Change in Body Weight (Completers). | 7.3 change in percent:baseline body weight | Standard Error 1.3 |
| Healthy Diet | Percent Change in Body Weight (Completers). | 7.0 change in percent:baseline body weight | Standard Error 1.3 |
Secondary
Change in Body Composition at Months 3 and 6
Time frame: April 2005 to May 2006
Secondary
Disease Biomarkers (Cholesterol, Triglycerides, Etc.) at Months 3 and 6
Time frame: April 2005 to May 2006
Secondary
Subjective Ratings of Appetite at Week 2 and Months 1, 2, 3, 4, 5, and 6
Time frame: April 2005 to May 2006