Effects of Fluid Milk in Attenuating Hyperglycemia and Hypertriglyceridemia After Meal

Oral Glucose Tolerance Test Clinical Trial

Official title:

Effects of Fluid Milk in Attenuating Hyperglycemia and Hypertriglyceridemia After Meal

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02894112
• Other study ID #: 1198
• 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

Related Conditions & MeSH terms

• High Fat Tolerance Test
• Hyperglycemia
• Hypertriglyceridemia
• Oral Glucose Tolerance Test

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