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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mara Z. Vitolins, Wake Forest University
ClinicalTrials.gov Identifier:
NCT01298817
First received: February 17, 2011
Last updated: December 10, 2012
Last verified: December 2012
  Purpose

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.

Condition Intervention
Abdominal Obesity
Dietary Supplement: Medifast meal replacement products

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Wake Forest School of Medicine:

Primary Outcome Measures:
  • Protocol Compliance [ Time Frame: Baseline, weekly (1 time per week for 11 weeks), and at 12 week follow-up ] [ Designated as safety issue: No ]
    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:
  • Change in Body Composition [ Time Frame: Baseline and at the 12-week follow up ] [ Designated as safety issue: No ]
    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.

  • Change in Cardiometabolic Health [ Time Frame: Baseline and at the 12-week follow up ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and at the 12 week follow up ] [ Designated as safety issue: No ]
    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).

  • Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: Baseline, weekly (1 time per week for 11 weeks), and at 12 week follow-up ] [ Designated as safety issue: Yes ]
    To document any adverse events associated with the soy-based meal replacement.


Enrollment: 24
Study Start Date: March 2011
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Soy, Prepared Meals
Soy-based meal replacement weight loss group with additional meals provided
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.
Other Name: Soy
Active Comparator: Non soy prepared meals
Non-soy based meal replacement weight loss group with additional meals provided
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). This group will receive the non soy supplements.
Other Name: whey

  Eligibility

Ages Eligible for Study:   60 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01298817

Locations
United States, North Carolina
Wake Forest University
Winston Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest School of Medicine
Investigators
Principal Investigator: Mara Vitolins, DrPH Wake Forest School of Medicine
  More Information

No publications provided

Responsible Party: Mara Z. Vitolins, Associate Professor, Wake Forest University
ClinicalTrials.gov Identifier: NCT01298817     History of Changes
Other Study ID Numbers: Pepper Grant
Study First Received: February 17, 2011
Last Updated: December 10, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Wake Forest School of Medicine:
Obesity
Aging
Soy
Weight Loss
Ectopic Fat

Additional relevant MeSH terms:
Obesity
Weight Loss
Obesity, Abdominal
Cardiac Complexes, Premature
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Body Weight Changes
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 24, 2014