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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Soy, Prepared Meals | Experimental | Soy-based meal replacement weight loss group with additional meals provided |
|
| Non soy prepared meals | Active Comparator | Non-soy based meal replacement weight loss group with additional meals provided |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mara Vitolins, DrPH | Wake Forest University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University | Winston-Salem | North Carolina | 27157 | United States |
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| ID | Term |
|---|---|
| D056128 | Obesity, Abdominal |
| D009765 | Obesity |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000067796 | Whey |
| ID | Term |
|---|---|
| D008892 | Milk |
| D001628 | Beverages |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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|
|
| 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). This group will receive the non soy supplements. |
|
|
| 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 |
| 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 |
| 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 |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |
| D003611 |
| Dairy Products |
| D005502 | Food |
| D019602 | Food and Beverages |