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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
72
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)
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.
Anschutz Health and Wellness Center, University of Colorado
Aurora, Colorado, United States
Body weight & body composition
Changes in skeletal muscle mass and fat mass will be measured using dual-energy X-ray absorptiometry (DXA)
Time frame: 0, 2, 4, 8, 12 mths
Blood lipid and lipoproteins
Changes in lipids and lipoproteins will be measured using the Vertical Auto Profile (VAP) Test
Time frame: 0, 2, 4, 8, 12 mths
C-reactive protein
Changes in inflammatory status will be assessed by measuring circulating c-reactive protein
Time frame: 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.
Time frame: 0, 12 mths
Quality of Life
Changes in the quality of life will be measured via Wellness Assessment Questionnaire
Time frame: 0, 4, 8, 12 mths
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