Status:
COMPLETED
Effect of Soy Protein and Colorado Diet on Weight Loss and Maintenance
Lead Sponsor:
University of Colorado, Denver
Collaborating Sponsors:
DuPont Nutrition and Health
Conditions:
Overweight
Obesity
Eligibility:
All Genders
18-55 years
Phase:
NA
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 cont...
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 compl...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 10 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 29 2016
Estimated Enrollment :
71 Patients enrolled
Trial Details
Trial ID
NCT03248804
Start Date
March 10 2015
End Date
October 29 2016
Last Update
November 7 2018
Active Locations (1)
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1
University of Colorado Denver, Anschutz Health and Wellness Center
Aurora, Colorado, United States, 80045