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

DuPont

Status: Completed

Conditions: Weight Loss; Overweight; Obesity

Treatments: Dietary Supplement: Colorado Diet with soy protein foods.; Behavioral: Colorado Diet with monetary payments

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02380963

1152341

Details and patient eligibility

About

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.

Full description

This is a randomized study comparing 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 State of Slim group classes. Subjects will be followed in the study for one year. The Colorado Diet consists of 3 phases: phase 1 (week 1-2), phase 2 (weeks 3 - 8), and phase 3 (weeks 9 - 16). The maintenance phase lasts from months 5 - 12. Body weight will be monitored at each study visit and body composition will be determined using DXA. Blood lipid and lipoprotein concentrations, health & wellness questionnaires, and fitness measures will also be assessed throughout the study.

Enrollment: 72 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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, or peanut)
• Taking medications that could cause weight loss or weight gain or alter plasma lipids (such as steroids, tricyclic antidepressants, chemotherapy, antipsychotics, prescribed or OTC 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.
• Known renal disease
• Clinical 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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72 participants in 2 patient groups

Colorado Diet with soy protein

Experimental group

Treatment:

Dietary Supplement: Colorado Diet with soy protein foods.

Colorado Diet

Active Comparator group

Treatment:

Behavioral: Colorado Diet with monetary payments