Calorie Restriction and Changes in Body Composition, Disease, Function, and Quality of Life in Older Adults

Study Overview
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Brief Summary
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The investigators want to determine if the benefits of weight loss outweigh the potential risk in a group of older adults. The investigators will test the hypothesis that changes in diet composition alone or in conjunction with weight loss will have a significant effect on fat stores, and as a result, improve cardiometabolic risk factors and functional status in adults 65 and older.

Official Title
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Calorie Restriction and Changes in Body Composition, Disease, Function, and Quality of Life in Older Adults

Conditions
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Obesity, Diabetes, Hypertension, Hyperlipidemia

Intervention / Treatment
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* Behavioral: Exercise
* Behavioral: Reduced Calorie Diet
* Behavioral: Weight Maintenance Diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: at least 65 years of age BMI 27 - 42 kg/m2 - at increased health risk (taking at least 1 medication for hypertension, hyperlipidemia, or type 2 diabetes) Exclusion Criteria: difficulties chewing or swallowing food digestive diseases that may affect the ability to follow a high fiber diet cognitive impairment depression recent weight change (+/- 10 lbs in the last 12 months) poorly controlled blood pressure history of non-skin cancer in last 5 years cardiovascular disease event in past 6 months or severe pulmonary disease or renal failure major liver dysfunction current smoker or quit less than months prior history of prior surgical procedures for weight control or liposuction use of estrogen or testosterone replacement therapy current use of insulin or sulfonylurea agents current use of corticosteroids > 5 days/month on average current use of medications for treatment of psychosis or manic-depressive illness use of weight-loss medications in previous 3 months dependence on others for food procurement or preparation ischemic changes on exercise treadmill test

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Weight Loss<br>Participants receive Exercise and Reduced Calorie Diet Interventions | Behavioral: Exercise<br>* Participants will participate in supervised exercise sessions<br>Behavioral: Reduced Calorie Diet<br>* Participants will follow a reduced calorie diet<br>|
| Active Comparator: Control<br>Participants receive Exercise Intervention | Behavioral: Exercise<br>* Participants will participate in supervised exercise sessions<br>|
| Active Comparator: Weight Maintenance<br>Participants receive Exercise and a Weight Maintenance Diet Interventions | Behavioral: Exercise<br>* Participants will participate in supervised exercise sessions<br>Behavioral: Weight Maintenance Diet<br>* Participants will follow a weight maintenance diet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Abdominal Fat Mass | Visceral adipose tissue (cm3) by MRI. Change is calculated as value at baseline minus value at 1 year | Baseline to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiometabolic Risk Factors | We are reporting change in blood glucose. Change is calculated as value at baseline minus value at 1 year | Baseline to 1 year | 
| Weight Change/Maintenance | The change in body weight at follow up of 1 year. Change is calculated as value at baseline minus value at 1 year | Baseline to 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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glucose, insulin, lipids, C-reactive protein, adiponectin, leptin, TNF alpha, IL-6, Quality of Life, functional status