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

Sponsor

University of Colorado, Denver (Other)

Overall Status

Completed

CT.gov ID

NCT03248804

Collaborator

DuPont Nutrition and Health (Industry)

Enrollment

Location

Arms

19.7

Actual Duration (Months)

3.6

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	Behavioral: Soy group Behavioral: Non-soy group	N/A

Detailed Description

This is a randomized study involving 60 study subjects (30 per arm). Investigators plan to enroll 72 subjects (36 per arm) in order to allow for any potential drop outs with the goal of 60 study completers. Investigators will compare 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 Colorado Diet group classes (State of Slim class). There will be 4 classes of 18 subjects each (two classes for each treatment group). Subjects will be followed in the study for 12 months. Subjects will be randomized into one of two treatment groups as follows:

Group 1 will participate in a State of Slim group class, receive a State of Slim book (describing the Colorado Diet), and will then purchase food items allowed in the Colorado Diet from the lists of acceptable foods in the State of Slim book.
Group 2 will participate in a State of Slim class, receive the State of Slim book, and be provided soy protein foods to be consumed as part of the Colorado Diet (subjects will receive up to 3 foods with approximately 20g of soy protein each, per day).

Study Design

Study Type:

Interventional

Actual Enrollment :

71 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Subjects are assigned either to the soy group or the non-soy group.Subjects are assigned either to the soy group or the non-soy group.

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.

Actual Study Start Date :

Mar 10, 2015

Actual Primary Completion Date :

Oct 29, 2016

Actual Study Completion Date :

Oct 29, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Soy Group Subjects in the soy group were asked to participate in the Colorado Diet program and to consume 3 soy food items per day.	Behavioral: Soy group
Other: Non-soy Group Subjects in the non-soy group were asked to participate in the Colorado Diet program and to avoid soy food products.	Behavioral: Non-soy group

Arm

Intervention/Treatment

Experimental: Soy Group

Subjects in the soy group were asked to participate in the Colorado Diet program and to consume 3 soy food items per day.

Behavioral: Soy group

Other: Non-soy Group

Subjects in the non-soy group were asked to participate in the Colorado Diet program and to avoid soy food products.

Behavioral: Non-soy group

Outcome Measures

Primary Outcome Measures

Change from baseline in % body weight at the end of a 16 week period [at month 4]
Change from baseline in body fat at the end of 16 week period [at month 4]
Change from baseline in % body weight at the end of a 52 week period [at month 12]
Change from baseline in body fat at the end of a 52 week period [at month 12]
Change from baseline in lipid panel results at end of 16 week period (total cholesterol) [at month 4]
Change from baseline in lipid panel results at end of 52 week period (total cholesterol) [at month 12]
Change from baseline in lipid panel results at end of 16 week period (LDL) [at month 4]
Change from baseline in lipid panel results at end of 52 week period (LDLl) [at month 12]
Change from baseline in lipid panel results at end of 16 week period (HDL) [at month 4]
Change from baseline in lipid panel results at end of 52 week period (HDL) [at month 12]
Change from baseline in lipid panel results at end of 16 week period (triglycerides) [at month 4]
Change from baseline in lipid panel results at end of 52 week period (triglycerides) [at month 12]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Males and females ages 18 - 55 years
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, eggs, or peanuts)
Taking medications that could cause weight loss or weight gain or alter plasma lipids (such as steroids, tricyclic antidepressants, chemotherapy, antipsychotics, prescribed or over-the-counter 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. Multivitamins containing niacin can be used as long as subject agrees to not change use of these during the study.
Known renal disease
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.