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

The Effect of Incorporating Soy Protein Foods in the Colorado Diet for Weight Loss and Maintenance

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Overweight; Weight Loss
• Intervention / Treatment: Dietary supplement: Colorado Diet with soy protein foods.; Behavioral: Colorado Diet with monetary payments

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Anschutz Health and Wellness Center, University of Colorado

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Colorado Diet with soy protein	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)
Active Comparator: Colorado Diet	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
C-reactive protein	Changes in inflammatory status will be assessed by measuring circulating c-reactive protein	0, 2, 4, 8, 12 mths
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
Quality of Life	Changes in the quality of life will be measured via Wellness Assessment Questionnaire	0, 4, 8, 12 mths

Collaborators and Investigators

• Sponsor: DuPont Nutrition and Health
• Collaborators: University of Colorado, Denver
• Investigators: Principal Investigator: James O Hill, PhD, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): November 1, 2016

Study Registration Dates

• First Submitted: February 23, 2015
• First Submitted That Met QC Criteria: March 1, 2015
• First Posted (Estimate): March 5, 2015

Study Record Updates

• Last Update Posted (Actual): October 4, 2019
• Last Update Submitted That Met QC Criteria: October 3, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Obesity; Soy; Cardiovascular Disease; Weight Loss; Muscle; Colorado Diet
• Additional Relevant MeSH Terms: Body Weight Changes; Weight Loss; Overweight; Body Weight
• Other Study ID Numbers: 1152341