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

Abdominal Obesity Clinical Trial

— SILVER  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01298817
• Other study ID #: IRB00015659
• Status: Completed
• Phase: N/A
• Start date: March 2011
• Est. completion date: December 2012

Study information

• Verified date: August 2018
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 79 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Abdominal Obesity
• Obesity, Abdominal
• Weight Loss

Intervention

Dietary Supplement:
• Medifast meal replacement products
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.
• Medifast meal replacement products
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.

Locations

Country	Name	City	State
United States	Wake Forest University	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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