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

Primary Purpose

Body Weight Changes

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
MicroDiet
Healthy Diet
Sponsored by
Pennington Biomedical Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Body Weight Changes

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Arm Type

Experimental

Active Comparator

Arm Label

MicroDiet

Healthy Diet

Arm Description

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).

Outcomes

Primary Outcome Measures

Body Weight Loss (kg and Percent) at Months 3 and 6
Percent Change in Body Weight (Completers).
Percent change in body weight from baseline to week 24(completers).

Secondary Outcome Measures

Change in Body Composition at Months 3 and 6
Disease Biomarkers (Cholesterol, Triglycerides, Etc.) at Months 3 and 6
Subjective Ratings of Appetite at Week 2 and Months 1, 2, 3, 4, 5, and 6

Full Information

First Posted
August 29, 2005
Last Updated
January 15, 2016
Sponsor
Pennington Biomedical Research Center
Collaborators
Sunny Health Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT00138645
Brief Title
The Effects of Formula Diet on Body Weight, Body Composition, and Biomarkers for Disease Compared to a Standard Diet
Acronym
FORMULA
Official Title
The Effects of Formula Diet on Body Weight, Body Composition, and Biomarkers for Disease Compared to a Standard Diet
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
May 2006 (Actual)
Study Completion Date
May 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pennington Biomedical Research Center
Collaborators
Sunny Health Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Body Weight Changes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MicroDiet
Arm Type
Experimental
Arm Description
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.
Arm Title
Healthy Diet
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
MicroDiet
Intervention Description
MicroDiet
Intervention Type
Behavioral
Intervention Name(s)
Healthy Diet
Intervention Description
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
Primary Outcome Measure Information:
Title
Body Weight Loss (kg and Percent) at Months 3 and 6
Time Frame
April 2005 to May 2006
Title
Percent Change in Body Weight (Completers).
Description
Percent change in body weight from baseline to week 24(completers).
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Change in Body Composition at Months 3 and 6
Time Frame
April 2005 to May 2006
Title
Disease Biomarkers (Cholesterol, Triglycerides, Etc.) at Months 3 and 6
Time Frame
April 2005 to May 2006
Title
Subjective Ratings of Appetite at Week 2 and Months 1, 2, 3, 4, 5, and 6
Time Frame
April 2005 to May 2006

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Corby K. Martin, Ph.D.
Organizational Affiliation
Pennington Biomedical Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pennington Biomedical Research Center
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States

12. IPD Sharing Statement

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

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