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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03248804
• Other study ID #: 14-1666
• Status: Completed
• Phase: N/A
• Start date: March 10, 2015
• Est. completion date: October 29, 2016

Study information

• Verified date: November 2018
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: October 29, 2016
• Est. primary completion date: October 29, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Body Weight
• Obesity
• Overweight
• Weight Loss

Intervention

Behavioral:
• Soy group

• Non-soy group

Locations

Country	Name	City	State
United States	University of Colorado Denver, Anschutz Health and Wellness Center	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	DuPont Nutrition and Health

Country where clinical trial is conducted

United States, 

References & Publications (24)

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* Note: There are 24 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in % body weight at the end of a 16 week period		at month 4
Primary	Change from baseline in body fat at the end of 16 week period		at month 4
Primary	Change from baseline in % body weight at the end of a 52 week period		at month 12
Primary	Change from baseline in body fat at the end of a 52 week period		at month 12
Primary	Change from baseline in lipid panel results at end of 16 week period (total cholesterol)		at month 4
Primary	Change from baseline in lipid panel results at end of 52 week period (total cholesterol)		at month 12
Primary	Change from baseline in lipid panel results at end of 16 week period (LDL)		at month 4
Primary	Change from baseline in lipid panel results at end of 52 week period (LDLl)		at month 12
Primary	Change from baseline in lipid panel results at end of 16 week period (HDL)		at month 4
Primary	Change from baseline in lipid panel results at end of 52 week period (HDL)		at month 12
Primary	Change from baseline in lipid panel results at end of 16 week period (triglycerides)		at month 4
Primary	Change from baseline in lipid panel results at end of 52 week period (triglycerides)		at month 12