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

Primary Purpose

Overweight, Obesity, Weight Loss

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Soy group

Non-soy group

About this trial

This is an interventional treatment trial for Overweight focused on measuring Obesity, Weight Loss, body composition, dietary protein

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

University of Colorado Denver, Anschutz Health and Wellness Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Soy Group

Non-soy Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change from baseline in % body weight at the end of a 16 week period

Change from baseline in body fat at the end of 16 week period

Change from baseline in % body weight at the end of a 52 week period

Change from baseline in body fat at the end of a 52 week period

Change from baseline in lipid panel results at end of 16 week period (total cholesterol)

Change from baseline in lipid panel results at end of 52 week period (total cholesterol)

Change from baseline in lipid panel results at end of 16 week period (LDL)

Change from baseline in lipid panel results at end of 52 week period (LDLl)

Change from baseline in lipid panel results at end of 16 week period (HDL)

Change from baseline in lipid panel results at end of 52 week period (HDL)

Change from baseline in lipid panel results at end of 16 week period (triglycerides)

Change from baseline in lipid panel results at end of 52 week period (triglycerides)

Secondary Outcome Measures

Full Information

NCT ID

NCT03248804

First Posted

August 9, 2017

Last Updated

November 6, 2018

Sponsor

University of Colorado, Denver

Collaborators

DuPont Nutrition and Health

1. Study Identification

Unique Protocol Identification Number

NCT03248804

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2018

Overall Recruitment Status

Completed

Study Start Date

March 10, 2015 (Actual)

Primary Completion Date

October 29, 2016 (Actual)

Study Completion Date

October 29, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Colorado, Denver

Collaborators

DuPont Nutrition and Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Overweight, Obesity, Weight Loss

Keywords

Obesity, Weight Loss, body composition, dietary protein

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

None (Open Label)

Allocation

Randomized

Enrollment

71 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Soy Group

Arm Type

Experimental

Arm Description

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

Arm Title

Non-soy Group

Arm Type

Other

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

Soy group

Intervention Type

Behavioral

Intervention Name(s)

Non-soy group

Primary Outcome Measure Information:

Title

Change from baseline in % body weight at the end of a 16 week period

Time Frame

at month 4

Title

Change from baseline in body fat at the end of 16 week period

Time Frame

at month 4

Title

Change from baseline in % body weight at the end of a 52 week period

Time Frame

at month 12

Title

Change from baseline in body fat at the end of a 52 week period

Time Frame

at month 12

Title

Change from baseline in lipid panel results at end of 16 week period (total cholesterol)

Time Frame

at month 4

Title

Change from baseline in lipid panel results at end of 52 week period (total cholesterol)

Time Frame

at month 12

Title

Change from baseline in lipid panel results at end of 16 week period (LDL)

Time Frame

at month 4

Title

Change from baseline in lipid panel results at end of 52 week period (LDLl)

Time Frame

at month 12

Title

Change from baseline in lipid panel results at end of 16 week period (HDL)

Time Frame

at month 4

Title

Change from baseline in lipid panel results at end of 52 week period (HDL)

Time Frame

at month 12

Title

Change from baseline in lipid panel results at end of 16 week period (triglycerides)

Time Frame

at month 4

Title

Change from baseline in lipid panel results at end of 52 week period (triglycerides)

Time Frame

at month 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

James O Hill, PhD

Organizational Affiliation

University of Colorado, Denver

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Colorado Denver, Anschutz Health and Wellness Center

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing Plan Description

Banked blood samples may be shared with other researchers (with subject consent)

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

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