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

NCT01298817 | Completed DMC

• 1 other identifier: IRB00015659
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Conditions

Abdominal Obesity

Keywords

Obesity; Aging; Soy; Weight Loss; Ectopic Fat

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in Body Composition

  Baseline and at the 12-week follow up

• Change in Cardiometabolic Health

  Baseline and at the 12-week follow up

• Change in Physical Function

  Baseline and at the 12 week follow up

• 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

Study Arms (2)

Soy, Prepared Meals

EXPERIMENTAL

Soy-based meal replacement weight loss group with additional meals provided

Dietary Supplement: Medifast meal replacement products

Non soy prepared meals

ACTIVE COMPARATOR

Non-soy based meal replacement weight loss group with additional meals provided

Dietary Supplement: Medifast meal replacement products

Interventions

Medifast meal replacement products DIETARY_SUPPLEMENT

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.

Also known as: Soy

Soy, Prepared Meals

Eligibility Criteria

• Age: 60 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest University

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Obesity, Abdominal; Obesity; Weight Loss

Interventions

Whey

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Intervention Hierarchy (Ancestors)

Milk; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Dairy Products; Food; Food and Beverages

Study Officials

• Mara Vitolins, DrPH

  Wake Forest University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2011
• First Posted: February 18, 2011
• Study Start: March 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: August 15, 2018

Record last verified: 2018-08

Locations

US (1)