Clinical trial NCT01298817: Use of a Soy-based Meal Replacement Weight Loss Intervention to Impact Ectopic Fat
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abdominal Obesity
Keywords: Obesity
Aging
Soy
Weight Loss
Ectopic Fat
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2011-02-18
Enrollment: 24
Sex: ALL
Minimum age (years): 60
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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.)

Primary outcomes:
measure: Protocol Compliance
timeFrame: Baseline, weekly (1 time per week for 11 weeks), and at 12 week follow-up
Secondary outcomes:
measure: Change in Body Composition
timeFrame: Baseline and at the 12-week follow up
measure: Change in Cardiometabolic Health
timeFrame: Baseline and at the 12-week follow up
measure: Change in Physical Function
timeFrame: Baseline and at the 12 week follow up
measure: Number of participants with adverse events as a measure of safety and tolerability
timeFrame: Baseline, weekly (1 time per week for 11 weeks), and at 12 week follow-up
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University
state: North Carolina
Study officials:
affiliation: Wake Forest University
name: Mara Vitolins, DrPH
role: PRINCIPAL_INVESTIGATOR
References: