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| Name | Class |
|---|---|
| Ideal Protein | UNKNOWN |
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This study will examine whether, compared to a standard, low-fat, calorie-restricted diet intervention, the clinic-supported Ideal Protein weight loss method will result in greater weight loss and improvement in cardiometabolic risk factors over 3 months among obese adults with cardiovascular disease (CVD) risk factors.
Restricting total calorie intake is emphasized in the 2013 American Heart Association/ American College of Cardiology/ The Obesity Society Guideline (AHA/ACC/TOS) for the Management of Overweight and Obesity in Adults for its effectiveness at reducing body weight and decreasing cardiometabolic risk factors. An implication of this focus on total quantity of calories consumed is that macronutrient composition of dietary intake and its effects on the hormonal milieu that regulates adipose accumulation in the human body do not play a significant role in weight loss. Such recommendations and the results of limited previous studies have led to the advice that all weight loss diets regardless of macronutrient composition will produce the same degree of weight loss if adherence to the diet is similar. In contrast, our previous studies have shown that despite comparable adherence to dietary goals, participants losing weight on a moderately carbohydrate-restricted, adequate protein regimen have improved cardiometabolic indicators as compared to those restricting fat. The RENEWAL trial will provide unique data on the efficacy of the Ideal Protein method (moderate carbohydrate restriction and adequate protein) for weight loss and improvement in cardiometabolic risk factors. The interventions will include a significant proportion of African-Americans, a group with very high rates of obesity which is often under-represented in trials examining the effects of weight loss diets. Findings from this trial may offer new evidence for the recommendation of specific macronutrient and behavioral approaches to the reduction of cardiometabolic risk factors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ideal Protein Weight Loss Protocol | Experimental | This arm will follow the Ideal Protein method as documented in the Ideal Protein Clinic Manual and in the Ideal Protein Coaches Manual. |
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| Standard Weight Loss | Active Comparator | This arm utilizes evidence-based, low fat, low calorie strategies that have been shown to be effective for long-term weight loss and weight loss maintenance. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ideal Protein Weight Loss Method | Behavioral | An initial visit will take place in which each participant assigned to the experimental group will complete a health profile questionnaire.The Ideal Protein method will be explained and the participant will be weighed, measured and given diet related informational materials. A staff member will assist the participant with the selection of foods and snacks to ensure adequate quantity for the week. Weekly follow-up visits of 15 minutes duration will be implemented with a telephone follow-up occurring during the first 4 days after the initial appointment. For 12 weeks Ideal Protein foods that are of the appropriate composition and quantity will be provided at weekly or twice monthly intervals as included in the diet. Dietary supplements will be provided (multivitamin, calcium/magnesium, potassium, omega-3, and Ideal Salt substitute). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in weight | Change in weight at follow-up | Baseline and three months |
| Measure | Description | Time Frame |
|---|---|---|
| Body Composition | Change in waist and hip circumference | Baseline and three months |
| Body Composition | Change in lean and fat mass | Baseline and three months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bogalusa Heart Study Clinic | Bogalusa | Louisiana | 70427 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35664249 | Result | Fernandez CA, Potts K, Bazzano LA. Effect of ideal protein versus low-fat diet for weight loss: A randomized controlled trial. Obes Sci Pract. 2021 Oct 15;8(3):299-307. doi: 10.1002/osp4.567. eCollection 2022 Jun. |
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| ID | Term |
|---|---|
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Participants (n=192) with BMI ≥30 and ≤49 will be randomized to one of two parallel study arms: Group A: Ideal Protein Weight Loss Intervention; Group B: Standard Low-Fat, Low-Calorie, Guideline-based Weight Loss Intervention. Participants will undergo baseline testing, and if eligible, will be randomly assigned to study group, undergo three months of their assigned study intervention, and clinical testing at baseline, 6, and 12 weeks.
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Throughout the study every effort will be made to ensure objective and blinded assessments of outcomes. Although participants will be told of their treatment assignment they will not be provided details about the intervention techniques of the other treatment groups. Focus will instead be maintained on the group to which they are assigned. Staff who obtain and record participant assessments at the clinical assessments will not be informed of the participant's treatment assignment and will not participate in the delivery of the study interventions.
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| Standard Weight Loss | Behavioral | This arm utilizes evidence-based strategies that have been shown to be effective for long-term weight loss and weight loss maintenance (including behavioral techniques, diet modification, and social support) consistent with the 2013 AHA/ACC/TOS Guideline for the Management of Overweight and Obesity in Adults. Participants in this arm will have an initial one hour consultation with a trained interventionist, where the fat goal and calorie restriction goal are explained. For 12 weeks low-fat reduced calorie foods that are of appropriate composition and quantity will be provided at weekly or twice monthly intervals as included in the diet. Dietary supplements will be provided (multivitamin, calcium/magnesium, potassium, omega-3, and Ideal Salt substitute). |
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| Lipid parameters | Change in lipid parameters | Baseline and three months |
| Fasting glucose | Change in fasting glucose | Baseline and three months |
| Continuously measured glucose | Change in continuously measured glucose | Baseline and three months |
| Systolic Blood Pressure | Change in systolic blood pressure | Baseline and three months |
| Diastolic Blood Pressure | Change in systolic blood pressure | Baseline and three months |
| Appetite | Change in appetite as measured by self-report questionnaires | Baseline and three months |
| Satiety | Change in satiety as measured by self-report questionnaires | Baseline and three months |