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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02894112
Other study ID # 1198
Secondary ID
Status Completed
Phase N/A
First received August 30, 2016
Last updated September 2, 2016
Start date April 2013
Est. completion date December 2015

Study information

Verified date September 2016
Source University of Texas at Austin
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date December 2015
Est. primary completion date December 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 20 Years to 40 Years
Eligibility 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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Intervention

Dietary Supplement:
non-fat milk
1 serving of non-fat fluid milk
carbohydrate control beverage
1 serving of carbohydrate control beverage (Carbohydrate powder + water)
caloric control beverage
1 serving of caloric control beverage (carbohydrate powder + protein powder + water)

Locations

Country Name City State
United States Cardiovascular Aging Research Laboratory Austin Texas

Sponsors (2)

Lead Sponsor Collaborator
University of Texas at Austin Dairy Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other insulin 2-4 hour postprandially Yes
Other glucagon 2-4 hour postprandially Yes
Other GIP 2-4 hour postprandially Yes
Other GLP 2-4 hour postprandially Yes
Primary blood glucose 2 hour postprandially Yes
Primary plasma triglyceride 4 hour postprandially Yes
Secondary femoral artery blood flow 2-4 hour postprandially No
Secondary brachial artery flow-mediated dilation 2-4 hour postprandially No
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