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| Name | Class |
|---|---|
| University of Colorado, Denver | OTHER |
Dietary protein is a key element of most effective weight loss regimens. This study will investigate the effects of consuming soy protein on body composition and cardiometabolic health within the context of an effective weight loss and maintenance program called the Colorado Diet.
This is a randomized study comparing the efficacy of inducing weight loss of two treatment arms all based on the Colorado Diet. Subjects will be randomly assigned to one of two study arms and instructed to follow the Colorado Diet by participating in weekly State of Slim group classes. Subjects will be followed in the study for one year. The Colorado Diet consists of 3 phases: phase 1 (week 1-2), phase 2 (weeks 3 - 8), and phase 3 (weeks 9 - 16). The maintenance phase lasts from months 5 - 12. Body weight will be monitored at each study visit and body composition will be determined using DXA. Blood lipid and lipoprotein concentrations, health & wellness questionnaires, and fitness measures will also be assessed throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Colorado Diet with soy protein | Experimental |
| |
| Colorado Diet | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colorado Diet with soy protein foods. | Dietary Supplement | Phase 1 (week 1-2): Participants will be given soy protein powder and asked to consume 3 protein shakes per day. Phase 2 (week 3-8): Participants will be given both protein powder and soy patties designed to be similar to other phase 2 acceptable foods and will be asked to consume 2 soy protein shakes and 1 soy patty per day. Phase 3 (week 9-16): Participants will be given protein powder, soy patties, and protein bars designed to be similar to other phase 3 acceptable foods and will be asked to consume 1 soy protein shake, 1 soy patty and 1 soy protein bar per day. Maintenance Phase (month 5-12): Participants will continue to receive study food products (protein powder, patties and protein bars) |
| Measure | Description | Time Frame |
|---|---|---|
| Body weight & body composition | Changes in skeletal muscle mass and fat mass will be measured using dual-energy X-ray absorptiometry (DXA) | 0, 2, 4, 8, 12 mths |
| Measure | Description | Time Frame |
|---|---|---|
| Blood lipid and lipoproteins | Changes in lipids and lipoproteins will be measured using the Vertical Auto Profile (VAP) Test | 0, 2, 4, 8, 12 mths |
| C-reactive protein | Changes in inflammatory status will be assessed by measuring circulating c-reactive protein |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James O Hill, PhD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anschutz Health and Wellness Center, University of Colorado | Aurora | Colorado | 80045 | United States |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| D015431 | Weight Loss |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| Colorado Diet with monetary payments | Behavioral | Phase 1 (week 1-2): Participants will be given monetary stipend and asked to consume 3 non-soy protein shakes per day. Phase 2 (week 3-8): Participants will be given monetary stipends and asked to consume 2 non-soy protein shakes per day. Phase 3 (week 9-16): Participants will be given monetary stipend and asked to consume 1 non-soy protein shake and 1 non-soy protein bar per day. Maintenance Phase (month 5-12): Participants will continue to receive monetary stipend. |
|
| 0, 2, 4, 8, 12 mths |
| Level of Fitness | Changes in the level of fitness will be measured by a 3 minute step test, grip strength, and flexibility testing. | 0, 12 mths |
| Quality of Life | Changes in the quality of life will be measured via Wellness Assessment Questionnaire | 0, 4, 8, 12 mths |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |