Effects of Fluid Milk in Attenuating Hyperglycemia and Hypertriglyceridemia After Meal

September 2, 2016 updated by: Miriam Pearman-Leary, University of Texas at Austin
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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Texas
      • Austin, Texas, United States, 78702
        • Cardiovascular Aging Research Laboratory

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Oral glucose tolerance test
100 g of glucose in a fruit punch flavored 8 oz drink
1 serving of non-fat fluid milk
1 serving of carbohydrate control beverage (Carbohydrate powder + water)
1 serving of caloric control beverage (carbohydrate powder + protein powder + water)
EXPERIMENTAL: High fat tolerance test
single high fat load determined by body weight.
1 serving of non-fat fluid milk
1 serving of carbohydrate control beverage (Carbohydrate powder + water)
1 serving of caloric control beverage (carbohydrate powder + protein powder + water)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
blood glucose
Time Frame: 2 hour postprandially
2 hour postprandially
plasma triglyceride
Time Frame: 4 hour postprandially
4 hour postprandially

Secondary Outcome Measures

Outcome Measure
Time Frame
femoral artery blood flow
Time Frame: 2-4 hour postprandially
2-4 hour postprandially
brachial artery flow-mediated dilation
Time Frame: 2-4 hour postprandially
2-4 hour postprandially

Other Outcome Measures

Outcome Measure
Time Frame
insulin
Time Frame: 2-4 hour postprandially
2-4 hour postprandially
glucagon
Time Frame: 2-4 hour postprandially
2-4 hour postprandially
GIP
Time Frame: 2-4 hour postprandially
2-4 hour postprandially
GLP
Time Frame: 2-4 hour postprandially
2-4 hour postprandially

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (ACTUAL)

December 1, 2015

Study Completion (ACTUAL)

December 1, 2015

Study Registration Dates

First Submitted

August 30, 2016

First Submitted That Met QC Criteria

September 2, 2016

First Posted (ESTIMATE)

September 9, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

September 9, 2016

Last Update Submitted That Met QC Criteria

September 2, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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