The Effects of Formula Diet on Body Weight, Body Composition, and Biomarkers for Disease Compared to a Standard Diet
Condition: Body Weight Changes
MeSH terms: Body Weight; Body Weight Changes
Intervention: MicroDiet; Healthy Diet
Intervention description: MicroDiet; 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
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

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.
    

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)