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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| Herbalife International of America, Inc. | INDUSTRY |
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This study will examine whether a higher protein meal replacement diet (consisting of 1 gram of protein per pound lean body mass) is more effective in causing weight loss compared to a standard meal replacement protein diet (consisting of ½ gram of protein per pound of lean body mass). The study will assign approximately 100 subjects (50 each) to the following arms 1) higher meal replacement diet program 2) standard meal replacement diet program. All participants will meet with a registered dietitian to provide nutrition education and behavior modification, including general exercise recommendations. As part of your participation, you must be willing to undergo a measurement of body fat, and blood tests, and be willing to use Herbalife Meal replacements as part of your diet for the duration of the study (one year).
There is concern that excess protein intake may be damaging to liver, renal function, and bone health. This study was designed to compare the effects of a high protein (HP) and an isocaloric meal standard protein (SP) weight loss plan on liver function, renal function and bone metabolism.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dietary Intervention and Higher protein meal replacement | Active Comparator | A higher protein meal replacement diet based on 1 gram of protein per pound of lean body mass |
|
| Dietary Intervention and Standard Protein Meal Replacement | Active Comparator | Standard protein meal replacement diet based on ½ gram of protein per pound of lean body mass |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Herbalife Meal Replacements | Dietary Supplement | Higher protein meal replacement diet based on 1 gram of protein per pound of lean body mass will improve weight loss in comparison to a standard protein meal replacement diet based on ½ gram of protein per pound of lean body mass |
| Measure | Description | Time Frame |
|---|---|---|
| The primary efficacy endpoint is the change in weight. | Baseline, 3, 6 and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary endpoints are changes in fasting plasma glucose levels associated with weight loss, insulin, blood pressure, lipid levels and body fat. | Baseline and 12 months |
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Inclusion Criteria:
h. Must have stable smoking habits (or be non-smokers) for at least 6 months prior to screening and agree not to intend to change such habits during the course of the study.
i. Subjects requiring the regular use of any prescription medication may be admitted to the study providing the dose is stable.
j. Ethical
Subject must sign the Institutional Review Board-approved written informed consent prior to he initiation of any study specific procedures or randomization. A subject will be excluded for any condition that might compromise the ability to give truly informed consent for participation in the study.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zhaoping Li, MD, PhD | University of California, Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Los Angeles | Los Angeles | California | 90095 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21194471 | Derived | Li Z, Treyzon L, Chen S, Yan E, Thames G, Carpenter CL. Protein-enriched meal replacements do not adversely affect liver, kidney or bone density: an outpatient randomized controlled trial. Nutr J. 2010 Dec 31;9:72. doi: 10.1186/1475-2891-9-72. |
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| ID | Term |
|---|---|
| D015431 | Weight Loss |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Herbalife Meal Replacements | Dietary Supplement | Higher protein meal replacement diet based on 1 gram of protein per pound of lean body mass will improve weight loss in comparison to a standard protein meal replacement diet based on ½ gram of protein per pound of lean body mass. |
|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |