Use of a Soy-based Meal Replacement Weight Loss Intervention to Impact Ectopic Fat
Public ClinicalTrials.gov record NCT01298817. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01298817
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 24 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 60 Years to 79 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 28, 2011
- Primary completion
- Nov 30, 2012
- Completion
- Nov 30, 2012
- Last update posted
- Aug 14, 2018
2011 – 2012
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Wake Forest University | Winston-Salem | North Carolina | 27157 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01298817, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 14, 2018 · Synced Sep 7, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01298817 live on ClinicalTrials.gov.