Clinical trial NCT03248804: 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
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Obesity
Weight Loss
Keywords: Obesity
Weight Loss
body composition
dietary protein
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: DuPont Nutrition and Health
First posted: 2017-08-14
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects are assigned either to the soy group or the non-soy group.
Primary purpose: TREATMENT

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline in % body weight at the end of a 16 week period
timeFrame: at month 4
measure: Change from baseline in body fat at the end of 16 week period
timeFrame: at month 4
measure: Change from baseline in % body weight at the end of a 52 week period
timeFrame: at month 12
measure: Change from baseline in body fat at the end of a 52 week period
timeFrame: at month 12
measure: Change from baseline in lipid panel results at end of 16 week period (total cholesterol)
timeFrame: at month 4
measure: Change from baseline in lipid panel results at end of 52 week period (total cholesterol)
timeFrame: at month 12
measure: Change from baseline in lipid panel results at end of 16 week period (LDL)
timeFrame: at month 4
measure: Change from baseline in lipid panel results at end of 52 week period (LDLl)
timeFrame: at month 12
measure: Change from baseline in lipid panel results at end of 16 week period (HDL)
timeFrame: at month 4
measure: Change from baseline in lipid panel results at end of 52 week period (HDL)
timeFrame: at month 12
measure: Change from baseline in lipid panel results at end of 16 week period (triglycerides)
timeFrame: at month 4
measure: Change from baseline in lipid panel results at end of 52 week period (triglycerides)
timeFrame: at month 12
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Denver, Anschutz Health and Wellness Center
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: James O Hill, PhD
role: PRINCIPAL_INVESTIGATOR
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