Use of a Soy-based Meal Replacement Weight Loss Intervention to Impact Ectopic Fat

Study Overview
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Brief Summary
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The main objectives of this study are to collect pilot data to assess feasibility (accrual, retention, compliance), to estimate the variability of outcome measures, and to obtain preliminary estimates of treatment efficacy based on group differences in body composition (decreases in ectopic fat stores while maintaining lean mass), cardio-metabolic risk factors including glucoregulatory function (glucose, insulin), inflammation (C-reactive protein, IL-6), blood pressure and lipids (HDL, LDL, TC, TG), and measures of physical function and muscle strength. While this is just a pilot study, randomization will be used so that the investigators can obtain a realistic estimate of accrual (which is often less in a randomized trial) and an unbiased estimate of treatment efficacy. The investigators will accomplish these objectives by conducting a 2-arm, 3-month randomized, clinical trial in 24 older (60-79), abdominally obese (BMI ≥30 kg/m2 and waist circumference ≥ 102 cm and ≥ 88 cm in men and women, respectively) men and women. Participants will be randomized to a soy-based or animal-based, 3-month, hypocaloric dietary intervention to achieve our specific aims: Primary Aim: To determine our ability to recruit and retain older, obese adults to a 3 month soy-based meal replacement weight loss intervention and assess the study participant's ability to adhere to the intervention protocol (weight, compliance logs, serum isoflavones). Secondary Aims: To estimate the variability of and obtain preliminary estimates of the effect of the soy-based meal replacement on measures of body composition, including abdominal (total, subcutaneous and visceral fat), liver, and pericardial fat; anthropometrics (body weight, waist/hip circumference); and whole body fat and lean mass. To estimate the variability of and obtain preliminary estimates of the effect of the soy-based meal replacement on biomarkers of cardiometabolic risk including glucoregulatory function (glucose, insulin), inflammation (C-reactive protein, IL-6), blood pressure and lipids (HDL, LDL, TC, TG). To estimate the variability of and obtain preliminary estimates of the effect of the soy-based meal replacement on physical function (short physical performance battery, 400-m walk) and muscle strength (grip and knee extensor strength) and size (CT thigh muscle). To document any adverse events associated with the soy-based meal replacement.

Official Title
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Use of a Soy-based Meal Replacement Weight Loss Intervention to Impact Ectopic Fat and Associated Cardio-metabolic Risk in Obese, Older Adults: A Feasibility Study

Conditions
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Abdominal Obesity

Intervention / Treatment
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* Dietary Supplement: Medifast meal replacement products
* Dietary Supplement: Medifast meal replacement products


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age = 60-79 years old BMI ≥ 27 kg/m2 Waist Circumference= men ≥ 102 cm; women ≥ 88 cm Non-impaired cognitive function (MMSE > 21) Willing to provide informed consent No contraindications for participation in weight loss Able to provide own transportation to study visits and intervention Willing to consume meal replacement products (i.e. no soy/dairy allergies, product found to be palatable) Not involved in any other research study Exclusion Criteria: Weight loss or gain (±5%) in past 6 months Body mass > 136 kg (DXA limit) Regular smoker (> 1 cigarette/day) within past year History of alcohol or substance abuse or dependence within the past 2 years (DSM IV criteria) Insulin-dependent or uncontrolled diabetes (FPG ≥ 126 mg/dL) Self-reported hepatitis Abnormal kidney function (creatinine > 2.0) Abnormal liver blood test (AST, ALT, total bilirubin- greater than twice the upper limit of normal; albumin - less than 2.0) Unstable angina MI, PCI or cardiac surgery < 3 month ago Uncontrolled blood pressure (> 160/90 mmHg) Chronic pulmonary disease (> mild or recent exacerbations) Thyroid disease Known significant hematological disease (including HBG < 11) Active known cancer requiring treatment in past year (except non-melanoma skin cancers) Life expectancy < 2 years Regular use of any medications that could influence study variables (growth/steroid hormones, including estrogen replacements, thiazolidinediones, statins, regular anti-inflammatory medications, weight loss medications, etc.)

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Soy, Prepared Meals<br>Soy-based meal replacement weight loss group with additional meals provided | Dietary Supplement: Medifast meal replacement products<br>* A total of 4 meal replacement (MR)products per participant per day will be used. Approximately 2/3rd of the Medifast® MR product line is soy protein-based (i.e. at least 7 g of total protein coming from soy) with the remaining 1/3rd of items deriving total protein content from animal sources (whey and egg). The soy used in Medifast products is Solae SUPRO® water-washed soy protein isolate. Depending on seasonal variations, soy MR products contain approximately 1.5-3.0 milligrams of soy isoflavones for every 1 gram of soy protein. Thus, participants in the soy treatment arm will consume at least 28 g/soy protein and 42-108 mg/isoflavones per day.<br>* Other names: Soy;|
| Active Comparator: Non soy prepared meals<br>Non-soy based meal replacement weight loss group with additional meals provided | Dietary Supplement: Medifast meal replacement products<br>* A total of 4 meal replacement (MR)products per participant per day will be used. Approximately 2/3rd of the Medifast® MR product line is soy protein-based (i.e. at least 7 g of total protein coming from soy) with the remaining 1/3rd of items deriving total protein content from animal sources (whey and egg). This group will receive the non soy supplements.<br>* Other names: whey;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Protocol Compliance | To determine our ability to recruit and retain older, obese adults to a 3 month soy-based meal replacement weight loss intervention and assess the study participant's ability to adhere to the intervention protocol (weight, compliance logs, serum isoflavones). | Baseline, weekly (1 time per week for 11 weeks), and at 12 week follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Body Composition | To estimate the variability of and obtain preliminary estimates of the effect of the soy-based meal replacement on measures of body composition, including abdominal (total, subcutaneous and visceral fat), liver, and pericardial fat; anthropometrics (body weight, waist/hip circumference); and whole body fat and lean mass. | Baseline and at the 12-week follow up | 
| Change in Cardiometabolic Health | To estimate the variability of and obtain preliminary estimates of the effect of the soy-based meal replacement on biomarkers of cardiometabolic risk including glucoregulatory function (glucose, insulin), inflammation (C-reactive protein, IL-6), blood pressure and lipids (HDL, LDL, TC, TG). | Baseline and at the 12-week follow up | 
| Change in Physical Function | To estimate the variability of and obtain preliminary estimates of the effect of the soy-based meal replacement on physical function (short physical performance battery, 400-m walk) and muscle strength (grip and knee extensor strength) and size (CT thigh muscle). | Baseline and at the 12 week follow up | 
| Number of participants with adverse events as a measure of safety and tolerability | To document any adverse events associated with the soy-based meal replacement. | Baseline, weekly (1 time per week for 11 weeks), and at 12 week follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Aging, Soy, Weight Loss, Ectopic Fat