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: NCT02380963
• Other study ID #: 1152341
• Status: Completed
• Phase: N/A
• Start date: February 2015
• Est. completion date: November 2016

Study information

• Verified date: October 2019
• Source: DuPont Nutrition and Health
• 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: November 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Body Weight
• Obesity
• Overweight
• Weight Loss

Intervention

Dietary Supplement:
• Colorado Diet with soy protein foods.
Phase 1 (week 1-2): Participants will be given soy protein powder and asked to consume 3 protein shakes per day. Phase 2 (week 3-8): Participants will be given both protein powder and soy patties designed to be similar to other phase 2 acceptable foods and will be asked to consume 2 soy protein shakes and 1 soy patty per day. Phase 3 (week 9-16): Participants will be given protein powder, soy patties, and protein bars designed to be similar to other phase 3 acceptable foods and will be asked to consume 1 soy protein shake, 1 soy patty and 1 soy protein bar per day. Maintenance Phase (month 5-12): Participants will continue to receive study food products (protein powder, patties and protein bars)

Behavioral:
• Colorado Diet with monetary payments
Phase 1 (week 1-2): Participants will be given monetary stipend and asked to consume 3 non-soy protein shakes per day. Phase 2 (week 3-8): Participants will be given monetary stipends and asked to consume 2 non-soy protein shakes per day. Phase 3 (week 9-16): Participants will be given monetary stipend and asked to consume 1 non-soy protein shake and 1 non-soy protein bar per day. Maintenance Phase (month 5-12): Participants will continue to receive monetary stipend.

Locations

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

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body weight & body composition	Changes in skeletal muscle mass and fat mass will be measured using dual-energy X-ray absorptiometry (DXA)	0, 2, 4, 8, 12 mths
Secondary	Blood lipid and lipoproteins	Changes in lipids and lipoproteins will be measured using the Vertical Auto Profile (VAP) Test	0, 2, 4, 8, 12 mths
Secondary	C-reactive protein	Changes in inflammatory status will be assessed by measuring circulating c-reactive protein	0, 2, 4, 8, 12 mths
Secondary	Level of Fitness	Changes in the level of fitness will be measured by a 3 minute step test, grip strength, and flexibility testing.	0, 12 mths
Secondary	Quality of Life	Changes in the quality of life will be measured via Wellness Assessment Questionnaire	0, 4, 8, 12 mths