The Beef WISE Study: Beef's Role in Weight Improvement, Satisfaction, and Energy
Primary Purpose
Weight Loss
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Beef group
Non-beef group
Sponsored by

About this trial
This is an interventional treatment trial for Weight Loss focused on measuring weight loss, red meats, obesity, lean body mass, body composition, dietary protein
Eligibility Criteria
Inclusion Criteria:
- Males and females between 18 - 50 years old
- BMI of 27 or greater
- 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 weekly group class for the first 16 weeks of the study and willing to participate in 4 study visits over the 6 month study period
Exclusion Criteria:
- Pregnant or trying to become pregnant.
- Diagnosis of type 1 or type 2 diabetes
- Individuals following a vegetarian/vegan only diet
- Food allergies (to red meats or other common protein sources)
- Taking medications that could cause weight loss or weight gain (such as steroids, tricyclic antidepressants, chemotherapy, antipsychotics, prescribed or over the counter weight loss agents). Oral contraceptives can be used as long as subject agrees to not change use of these during the study. Vitamins and minerals which do not have a weight effect are allowed as long as use is continued without change during the study.
- Current Eating disorder (anorexia or bulimia)
- 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 high protein diet and/or 70 minutes of exercise daily would be inadvisable
- LDL cholesterol levels above 160 mg/dl or triglycerides above 400 mg/dl.
Untreated or unstable hypothyroidism. Thyroid medications must be stable for at least 3 months.
-
Sites / Locations
- University of Colorado Denver
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Beef group
Non-beef group
Arm Description
Subjects in this group are asked to consume 4 or more servings of beef per week and to exclude all other red meats from their diet for the 6 month study.
Subjects in this group are asked to avoid all red meats from their diet for the 6 month study.
Outcomes
Primary Outcome Measures
Change from baseline in % body weight at the end of a 16 week period and at the end of the 6 month period
Secondary Outcome Measures
Change from baseline in % body fat at the end of a 16 week period
Change from baseline in lipid panel results at end of 16 week period and end of 6 month period
Change from baseline in fasting blood glucose results at end of 16 week period and end of 6 month period.
Change from baseline in hemoglobin A1C results at end of 16 week period and end of 6 month period.
Differences in responses to study questionnaires between the two groups regarding satisfaction with the weight loss program.
Differences in responses to study questionnaires between the two groups regarding adherence to the weight loss program.
Full Information
NCT ID
NCT02627105
First Posted
December 3, 2015
Last Updated
November 6, 2018
Sponsor
University of Colorado, Denver
Collaborators
National Cattlemen's Beef Association
1. Study Identification
Unique Protocol Identification Number
NCT02627105
Brief Title
The Beef WISE Study: Beef's Role in Weight Improvement, Satisfaction, and Energy
Official Title
The Beef WISE Study: Beef's Role in Weight Improvement, Satisfaction, and Energy
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
November 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
National Cattlemen's Beef Association
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a 6 month long study to evaluate the inclusion or exclusion of beef within a weight loss program.
Detailed Description
This study will compare two protein sources: proteins to include beef as the sole source of red meat compared to proteins excluding red meat within the context of an effective higher-protein weight loss and maintenance program derived from the Colorado Diet.
All subjects will participate in a group-based program consisting of 16 weekly classes in 3-phases designed to produce weight loss and teach participants how to achieve a lifestyle to keep weight off permanently. All groups will be closed (same subjects, same leader) and will consist of 20 participants. Participants in both groups will receive instruction in cooking, recipes, and shopping instruction (using our grocery laboratory). This training will include strategies, tips and preparation techniques for preparing high protein meals according to their assigned groups. All subjects are given exercise plans and all subjects will receive memberships to the Anschutz Health and Wellness Center fitness center for the duration of the study.
After completion of the 16-week program, subjects will be asked to follow the program on their own for an additional 2 months.
This is a randomized study involving 120 study subjects (60 per arm). The investigators will compare the efficacy of inducing weight loss of two treatment arms derived from the Colorado Diet. Subjects will be randomly assigned to one of two study arms and instructed to follow the higher-protein diet by participating in weekly group classes for the first four months of the study. There will be 6 classes of 20 subjects each (three classes for each treatment group). Subjects will be followed in the study for 6 months. Subjects will be randomized into one of two treatment groups as follows:
Group 1(SOS+B): Subjects will participate in a State of Slim group class, receive a State of Slim book (describing the Colorado Diet), and will receive stipends to be used to help purchase protein food items allowed in the Colorado Diet as modified. The Colorado diet is a high protein (estimated 120-160g/day), low carb and low fat diet. Subjects will be directed and instructed to include beef as their sole source of red meat as a protein source during the study. Subjects will follow the diet protein guidelines, but will be directed and instructed to consume 4 or more servings of beef per week and instructed not to consume any other red meats. Other red meats to be avoided include pork, veal, lamb, buffalo and venison. Subjects will be advised to use the monetary stipends to purchase items from the lists of acceptable foods from the SOS book (to include beef products). Processed beef items will be allowed as identified by a list provided to the subjects.
Group 2 (SOS): Subjects will participate in a State of Slim class, receive the State of Slim book (describing the Colorado Diet), and will receive stipends to be used to help purchase protein food items allowed in the Colorado diet as modified. Subjects will be directed and instructed to exclude beef and instructed not to consume any other red meats. Other red meats to be avoided include pork, veal, lamb, buffalo, and venison.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Loss
Keywords
weight loss, red meats, obesity, lean body mass, body composition, dietary protein
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Beef group
Arm Type
Experimental
Arm Description
Subjects in this group are asked to consume 4 or more servings of beef per week and to exclude all other red meats from their diet for the 6 month study.
Arm Title
Non-beef group
Arm Type
Other
Arm Description
Subjects in this group are asked to avoid all red meats from their diet for the 6 month study.
Intervention Type
Behavioral
Intervention Name(s)
Beef group
Intervention Description
Subjects in the beef group will be asked to consume 4 or more servings of beef per week (and to avoid all other red meats) during the 6 month study.
Intervention Type
Behavioral
Intervention Name(s)
Non-beef group
Intervention Description
Subjects in the non-beef group will be asked to avoid all red meats during the 6 month study.
Primary Outcome Measure Information:
Title
Change from baseline in % body weight at the end of a 16 week period and at the end of the 6 month period
Time Frame
16 weeks and 6 months
Secondary Outcome Measure Information:
Title
Change from baseline in % body fat at the end of a 16 week period
Time Frame
16 weeks
Title
Change from baseline in lipid panel results at end of 16 week period and end of 6 month period
Time Frame
16 weeks and 6 months
Title
Change from baseline in fasting blood glucose results at end of 16 week period and end of 6 month period.
Time Frame
16 weeks and 6 months
Title
Change from baseline in hemoglobin A1C results at end of 16 week period and end of 6 month period.
Time Frame
16 weeks and 6 months
Title
Differences in responses to study questionnaires between the two groups regarding satisfaction with the weight loss program.
Time Frame
6 months
Title
Differences in responses to study questionnaires between the two groups regarding adherence to the weight loss program.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Males and females between 18 - 50 years old
BMI of 27 or greater
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 weekly group class for the first 16 weeks of the study and willing to participate in 4 study visits over the 6 month study period
Exclusion Criteria:
Pregnant or trying to become pregnant.
Diagnosis of type 1 or type 2 diabetes
Individuals following a vegetarian/vegan only diet
Food allergies (to red meats or other common protein sources)
Taking medications that could cause weight loss or weight gain (such as steroids, tricyclic antidepressants, chemotherapy, antipsychotics, prescribed or over the counter weight loss agents). Oral contraceptives can be used as long as subject agrees to not change use of these during the study. Vitamins and minerals which do not have a weight effect are allowed as long as use is continued without change during the study.
Current Eating disorder (anorexia or bulimia)
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 high protein diet and/or 70 minutes of exercise daily would be inadvisable
LDL cholesterol levels above 160 mg/dl or triglycerides above 400 mg/dl.
Untreated or unstable hypothyroidism. Thyroid medications must be stable for at least 3 months.
-
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
University of Colorado Denver
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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The Beef WISE Study: Beef's Role in Weight Improvement, Satisfaction, and Energy
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