Back to resultsEffect of Soy Protein and Colorado Diet on Weight Loss and Maintenance
Primary Purpose
Overweight, Obesity, Weight Loss
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Colorado Diet with soy protein foods.
Colorado Diet with monetary payments
Sponsored by
About this trial
This is an interventional treatment trial for Overweight focused on measuring Soy, Obesity, Weight Loss, Muscle, Cardiovascular Disease, Colorado Diet
Eligibility Criteria
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.
Sites / Locations
- Anschutz Health and Wellness Center, University of Colorado
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Colorado Diet with soy protein
Colorado Diet
Arm Description
Outcomes
Primary Outcome Measures
Body weight & body composition
Changes in skeletal muscle mass and fat mass will be measured using dual-energy X-ray absorptiometry (DXA)
Secondary Outcome Measures
Blood lipid and lipoproteins
Changes in lipids and lipoproteins will be measured using the Vertical Auto Profile (VAP) Test
C-reactive protein
Changes in inflammatory status will be assessed by measuring circulating c-reactive protein
Level of Fitness
Changes in the level of fitness will be measured by a 3 minute step test, grip strength, and flexibility testing.
Quality of Life
Changes in the quality of life will be measured via Wellness Assessment Questionnaire
Full Information
NCT ID
NCT02380963
First Posted
February 23, 2015
Last Updated
October 3, 2019
Sponsor
DuPont Nutrition and Health
Collaborators
University of Colorado, Denver
1. Study Identification
Unique Protocol Identification Number
NCT02380963
Brief Title
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
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
November 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
DuPont Nutrition and Health
Collaborators
University of Colorado, Denver
4. Oversight
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity, Weight Loss
Keywords
Soy, Obesity, Weight Loss, Muscle, Cardiovascular Disease, Colorado Diet
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Colorado Diet with soy protein
Arm Type
Experimental
Arm Title
Colorado Diet
Arm Type
Active Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Colorado Diet with soy protein foods.
Intervention Description
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)
Intervention Type
Behavioral
Intervention Name(s)
Colorado Diet with monetary payments
Intervention Description
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.
Primary Outcome Measure Information:
Title
Body weight & body composition
Description
Changes in skeletal muscle mass and fat mass will be measured using dual-energy X-ray absorptiometry (DXA)
Time Frame
0, 2, 4, 8, 12 mths
Secondary Outcome Measure Information:
Title
Blood lipid and lipoproteins
Description
Changes in lipids and lipoproteins will be measured using the Vertical Auto Profile (VAP) Test
Time Frame
0, 2, 4, 8, 12 mths
Title
C-reactive protein
Description
Changes in inflammatory status will be assessed by measuring circulating c-reactive protein
Time Frame
0, 2, 4, 8, 12 mths
Title
Level of Fitness
Description
Changes in the level of fitness will be measured by a 3 minute step test, grip strength, and flexibility testing.
Time Frame
0, 12 mths
Title
Quality of Life
Description
Changes in the quality of life will be measured via Wellness Assessment Questionnaire
Time Frame
0, 4, 8, 12 mths
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James O Hill, PhD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
Anschutz Health and Wellness Center, University of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effect of Soy Protein and Colorado Diet on Weight Loss and Maintenance
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