The Effects of Formula Diet on Body Weight, Body Composition, and Biomarkers for Disease Compared to a Standard Diet

NCT00138645 | Completed Phase 4 Results

• 1 other identifier: PBRC 25004
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Body Weight Changes

Outcome Measures

Primary Outcomes (2)

• Body Weight Loss (kg and Percent) at Months 3 and 6

  April 2005 to May 2006

• Percent Change in Body Weight (Completers).

  Percent change in body weight from baseline to week 24(completers).

  24 weeks

Secondary Outcomes (3)

• 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

Study Arms (2)

MicroDiet

EXPERIMENTAL

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.

Behavioral: MicroDiet

Healthy Diet

ACTIVE COMPARATOR

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).

Behavioral: Healthy Diet

Interventions

MicroDiet BEHAVIORAL

MicroDiet

MicroDiet

Healthy Diet BEHAVIORAL

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

Healthy Diet

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \> 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)

Sponsors & Collaborators

• Pennington Biomedical Research Center: lead
• Sunny Health Co., Ltd.: collaborator

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

MeSH Terms

Conditions

Body Weight Changes

Interventions

Diet, Healthy

Condition Hierarchy (Ancestors)

Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Results Point of Contact

• Title: Corby K. Martin, Ph.D.; Assistant Professor
• Organization: Pennington Biomedical Research Center

martinck@pbrc.edu

225-763-2585

Study Officials

• Corby K. Martin, Ph.D.

  Pennington Biomedical Research Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 29, 2005
• First Posted: August 30, 2005
• Study Start: April 1, 2005
• Primary Completion: May 1, 2006
• Study Completion: May 1, 2006
• Last Updated: February 8, 2016
• Results First Posted: June 10, 2009

Record last verified: 2016-01

Locations

US (1)