The Effects of Formula Diet on Body Weight, Body Composition, and Biomarkers for Disease Compared to a Standard Diet (FORMULA)
Body Weight Changes
About this trial
This is an interventional treatment trial for Body Weight Changes
Eligibility 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)
Sites / Locations
- Pennington Biomedical Research Center
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
MicroDiet
Healthy Diet
Participants randomized to the MicroDiet group (1200 kcal/day) will be instructed by a Registered Dietitian to consume (one shake and 3 cookies; 240 kcal) for two meals each day for Months 1 through 3. They will be provided with meal plans for the meal that they do not replace with MicroDiet. During Months 4 through 6, participants in the MicroDiet group will be instructed to replace one meal per day with MD (the energy content of the meal plan will still be 1200 kcal/day). Participants will also be encouraged to eat or drink MD for snacks. The rest of the diet will consist of healthy foods, as outlined above. To help participants adhere to the MicroDiet regimen, they will meet with a registered dietitian for one hour at Week 0 and 30 minutes at Weeks 2 and 4, and every month thereafter.
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. The Healthy Diet will consist of the same foods that are used in the meal plans for the MicroDiet group. The Healthy Diet group will be instructed not to use meal replacements such as shakes (e.g., Slim Fast®), nutrition bars (e.g., Balance Bar®), or portion-controlled meals (e.g., Healthy Choice entrees).