NCT02380963

Effect of Soy Protein and Colorado Diet on Weight Loss and Maintenance

The Effect of Incorporating Soy Protein Foods in the Colorado Diet for Weight Loss and Maintenance

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: DuPont Nutrition and Health · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Overweight
• Obesity
• Weight Loss

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Colorado Diet with soy protein foods.	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)
BEHAVIORAL	Colorado Diet with monetary payments	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.

Timeline

• Start date: 2015-02-01
• Primary completion: 2016-10-01
• Completion: 2016-11-01
• First posted: 2015-03-05
• Last updated: 2019-10-04

Locations

1 site across 1 country: United States