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

Completed · Not applicable

Conditions studied: Overweight, Obesity, Weight Loss

In brief

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.

Key facts

Study ID

NCT03248804

Run by

University of Colorado, Denver

People needed

71

Starts

2015-03-10

Expected to finish

2016-10-29

Last updated by the study team

2018-11-07

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.