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

Not Applicable

Completed

• Conditions: Abdominal Obesity

• Registration Number: NCT01298817
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

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:

1. 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.

2. 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).

3. 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).

4. To document any adverse events associated with the soy-based meal replacement.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-02-17
• Study First Submitted QC: 2011-02-17
• Study First Posted: 2011-02-18
• Study Start: 2011-03
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-13
• Last Update Posted: 2018-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Protocol Compliance	Baseline, weekly (1 time per week for 11 weeks), and at 12 week follow-up	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 Outcome Measures

Name	Time	Method
Number of participants with adverse events as a measure of safety and tolerability	Baseline, weekly (1 time per week for 11 weeks), and at 12 week follow-up	To document any adverse events associated with the soy-based meal replacement.
Change in Cardiometabolic Health	Baseline and at the 12-week follow up	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).
Change in Physical Function	Baseline and at the 12 week follow up	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).
Change in Body Composition	Baseline and at the 12-week follow up	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.

Trial Locations

Locations (1)

Wake Forest University; 🇺🇸 Winston-Salem, North Carolina, United States