Effects of Fluid Milk in Attenuating Hyperglycemia and Hypertriglyceridemia After Meal
Primary Purpose
Oral Glucose Tolerance Test, High Fat Tolerance Test
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
non-fat milk
carbohydrate control beverage
caloric control beverage
Sponsored by
About this trial
This is an interventional treatment trial for Oral Glucose Tolerance Test focused on measuring endothelial dependent vasodilation, blood flow, blood glucose, triglycerides, non-fat milk, dairy
Eligibility Criteria
Inclusion Criteria:
- Apparently health, sedentary. All subjects will have a BMI of 25-35 kg/m2.
Exclusion Criteria:
- Candidates who are taking cardiovascular-acting drugs will not be eligible for participation. Subjects with significant intima-media thickening, plaque formation, characteristics of atherosclerosis, metabolic diseases, gastrointestinal disorders, and/or renal disease will be excluded from the study. Additional exclusion criteria will be cow milk allergy or lactose intolerance, pregnancy or lactation, and alcohol abuse.
Sites / Locations
- Cardiovascular Aging Research Laboratory
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Oral glucose tolerance test
High fat tolerance test
Arm Description
100 g of glucose in a fruit punch flavored 8 oz drink
single high fat load determined by body weight.
Outcomes
Primary Outcome Measures
blood glucose
plasma triglyceride
Secondary Outcome Measures
femoral artery blood flow
brachial artery flow-mediated dilation
Full Information
NCT ID
NCT02894112
First Posted
August 30, 2016
Last Updated
September 2, 2016
Sponsor
University of Texas at Austin
Collaborators
Dairy Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT02894112
Brief Title
Effects of Fluid Milk in Attenuating Hyperglycemia and Hypertriglyceridemia After Meal
Official Title
Effects of Fluid Milk in Attenuating Hyperglycemia and Hypertriglyceridemia After Meal
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas at Austin
Collaborators
Dairy Research Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Epidemiological studies indicate that risk of type 2 diabetes is lower when milk is consumed in the regular diet. Milk products are unique in that they produce high insulin response despite their low glycemic index. The general aim of the proposed study is to determine the effect of fluid milk on attenuating the postprandial surge in plasma glucose and triglyceride after meals and its associated physiological mechanisms. The investigators hypothesize that the consumption of one or two servings of non-fat milk added to a standard oral glucose tolerance test (OGTT) solution or the high fat tolerance test meal will attenuate postprandial hyperglycemia and triglyceridemia. The investigators hypothesize that the postulated improvement in postprandial metabolic response due to the consumption of fluid milk will be associated with increased postprandial insulin secretion as well as insulin-mediated endothelial vasodilation and whole-limb perfusion.
Detailed Description
A double blind randomized placebo-controlled crossover experimental design with six treatments will be used. A total of 30 young (20-40 year old) healthy men and women will serve as subjects. Following 2 days of physical activity and dietary control, subjects will consume a standard OGTT load or high fat tolerance load on the morning of Day 3. The solution used in the meals will be mixed with one or two servings of non-fat milk or placebo (either carbohydrate matched or total calorie matched). Before and after the test meals are consumed, blood samples will be obtained for later analysis of glucose, triglycerides, insulin, and inflammatory cytokines and brachial artery flow-mediated dilation and femoral artery vascular conductance will be measured. The present research project should provide new and clinically useful insight into the role of conventional dairy products on metabolic homeostasis. If the working hypotheses are supported, the information could be used as an initial/preliminary basis for recommendations for the consumption of fluid milk in the prevention of metabolic diseases.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Glucose Tolerance Test, High Fat Tolerance Test
Keywords
endothelial dependent vasodilation, blood flow, blood glucose, triglycerides, non-fat milk, dairy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Oral glucose tolerance test
Arm Type
Experimental
Arm Description
100 g of glucose in a fruit punch flavored 8 oz drink
Arm Title
High fat tolerance test
Arm Type
Experimental
Arm Description
single high fat load determined by body weight.
Intervention Type
Dietary Supplement
Intervention Name(s)
non-fat milk
Intervention Description
1 serving of non-fat fluid milk
Intervention Type
Dietary Supplement
Intervention Name(s)
carbohydrate control beverage
Intervention Description
1 serving of carbohydrate control beverage (Carbohydrate powder + water)
Intervention Type
Dietary Supplement
Intervention Name(s)
caloric control beverage
Intervention Description
1 serving of caloric control beverage (carbohydrate powder + protein powder + water)
Primary Outcome Measure Information:
Title
blood glucose
Time Frame
2 hour postprandially
Title
plasma triglyceride
Time Frame
4 hour postprandially
Secondary Outcome Measure Information:
Title
femoral artery blood flow
Time Frame
2-4 hour postprandially
Title
brachial artery flow-mediated dilation
Time Frame
2-4 hour postprandially
Other Pre-specified Outcome Measures:
Title
insulin
Time Frame
2-4 hour postprandially
Title
glucagon
Time Frame
2-4 hour postprandially
Title
GIP
Time Frame
2-4 hour postprandially
Title
GLP
Time Frame
2-4 hour postprandially
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Apparently health, sedentary. All subjects will have a BMI of 25-35 kg/m2.
Exclusion Criteria:
Candidates who are taking cardiovascular-acting drugs will not be eligible for participation. Subjects with significant intima-media thickening, plaque formation, characteristics of atherosclerosis, metabolic diseases, gastrointestinal disorders, and/or renal disease will be excluded from the study. Additional exclusion criteria will be cow milk allergy or lactose intolerance, pregnancy or lactation, and alcohol abuse.
Facility Information:
Facility Name
Cardiovascular Aging Research Laboratory
City
Austin
State/Province
Texas
ZIP/Postal Code
78702
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Effects of Fluid Milk in Attenuating Hyperglycemia and Hypertriglyceridemia After Meal
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