MedTrace Logo

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

NCT02380963 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2019-10-04

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • University of Colorado, Denver

    collaborator OTHER

  • DuPont Nutrition and Health

    lead INDUSTRY

Principal Investigators

  • James O Hill, PhD · University of Colorado, Denver

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2016-10-31
Completion
2016-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02380963 on ClinicalTrials.gov