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

NCT02380963 | Completed

• 1 other identifier: 1152341
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight; Obesity; Weight Loss

Keywords

Soy; Obesity; Weight Loss; Muscle; Cardiovascular Disease; Colorado Diet

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Blood lipid and lipoproteins

  0, 2, 4, 8, 12 mths

• C-reactive protein

  0, 2, 4, 8, 12 mths

• Level of Fitness

  0, 12 mths

• Quality of Life

  0, 4, 8, 12 mths

Study Arms (2)

Colorado Diet with soy protein

EXPERIMENTAL

Dietary Supplement: Colorado Diet with soy protein foods.

Colorado Diet

ACTIVE COMPARATOR

Behavioral: Colorado Diet with monetary payments

Interventions

Colorado Diet with soy protein foods. DIETARY_SUPPLEMENT

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)

Colorado Diet with soy protein

Colorado Diet with monetary payments BEHAVIORAL

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.

Colorado Diet

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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, 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.

Sponsors & Collaborators

• DuPont Nutrition and Health: lead
• University of Colorado, Denver: collaborator

Study Sites (1)

Anschutz Health and Wellness Center, University of Colorado

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Overweight; Obesity; Weight Loss; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Officials

• James O Hill, PhD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2015
• First Posted: March 5, 2015
• Study Start: February 1, 2015
• Primary Completion: October 1, 2016
• Study Completion: November 1, 2016
• Last Updated: October 4, 2019

Record last verified: 2019-10

Locations

US (1)