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

November 6, 2018 updated by: University of Colorado, Denver

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

71

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Denver, Anschutz Health and Wellness Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Males and females ages 18 - 55 years
  2. BMI between 27-40
  3. Weight stable (have not lost or gained more than 10 pounds in the last 3 months)
  4. Generally healthy
  5. Able to exercise 70 minutes per day at moderate intensity
  6. 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:

  1. Pregnant or trying to become pregnant.
  2. Diagnosis of type 1 or type 2 diabetes
  3. Individuals following a vegetarian only diet
  4. Food allergies (to soy, dairy, wheat/gluten, eggs, or peanuts)
  5. 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.
  6. Known renal disease
  7. hypothyroidism
  8. 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).
  9. Any medical condition for which following a diet and/or 70 minutes of exercise daily would be inadvisable
  10. LDL cholesterol levels above 190 mg/dl or triglycerides above 400 mg/dl.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Collaborators

DuPont Nutrition and Health

Investigators

  • Principal Investigator: James O Hill, PhD, University of Colorado, Denver

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 10, 2015

Primary Completion (Actual)

October 29, 2016

Study Completion (Actual)

October 29, 2016

Study Registration Dates

First Submitted

August 9, 2017

First Submitted That Met QC Criteria

August 11, 2017

First Posted (Actual)

August 14, 2017

Study Record Updates

Last Update Posted (Actual)

November 7, 2018

Last Update Submitted That Met QC Criteria

November 6, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-1666

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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