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

Sponsor

DuPont Nutrition and Health (Industry)

Overall Status

Completed

CT.gov ID

NCT02380963

Collaborator

University of Colorado, Denver (Other)

Enrollment

Location

Arms

Duration (Months)

3.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Overweight Obesity Weight Loss	Dietary Supplement: Colorado Diet with soy protein foods. Behavioral: Colorado Diet with monetary payments	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

72 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Feb 1, 2015

Actual Primary Completion Date :

Oct 1, 2016

Actual Study Completion Date :

Nov 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Colorado Diet with soy protein	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)
Active Comparator: Colorado Diet	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.

Arm

Intervention/Treatment

Experimental: Colorado Diet with soy protein

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)

Active Comparator: Colorado Diet

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.

Outcome Measures

Primary Outcome Measures

Body weight & body composition [0, 2, 4, 8, 12 mths]
Changes in skeletal muscle mass and fat mass will be measured using dual-energy X-ray absorptiometry (DXA)

Secondary Outcome Measures

Blood lipid and lipoproteins [0, 2, 4, 8, 12 mths]
Changes in lipids and lipoproteins will be measured using the Vertical Auto Profile (VAP) Test
C-reactive protein [0, 2, 4, 8, 12 mths]
Changes in inflammatory status will be assessed by measuring circulating c-reactive protein
Level of Fitness [0, 12 mths]
Changes in the level of fitness will be measured by a 3 minute step test, grip strength, and flexibility testing.
Quality of Life [0, 4, 8, 12 mths]
Changes in the quality of life will be measured via Wellness Assessment Questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

BMI between 27-40
Weight stable (have not lost or gained more than 10 pounds in the last 3 months)
Generally healthy
Able to exercise 70 minutes per day at moderate intensity
Willing and able to participate in a State of Slim group class for the first 16 weeks of the study and willing to participate in 5 study visits over the 12 month study period.

Exclusion Criteria:

Pregnant or trying to become pregnant.
Diagnosis of type 1 or type 2 diabetes
Individuals following a vegetarian only diet
Food allergies (to soy, dairy, wheat/gluten, or peanut)
Taking medications that could cause weight loss or weight gain or alter plasma lipids (such as steroids, tricyclic antidepressants, chemotherapy, antipsychotics, prescribed or OTC weight loss agents, statins, fibrates, niacin, etc). Oral contraceptives can be used as long as subject agrees to not change use of these during the study.
Known renal disease
Clinical hypothyroidism
Current alcohol or drug abuse or dependence (Subjects who have quit smoking in the last 6 months will be excluded. Smokers whose smoking habits have been stable for the last 6 months and which remain stable during the study can be included).
Any medical condition for which following a diet and/or 70 minutes of exercise daily would be inadvisable
LDL cholesterol levels above 190 mg/dl or triglycerides above 400 mg/dl.