Effects of Fluid Milk in Attenuating Hyperglycemia and Hypertriglyceridemia After Meal

NCT ID: NCT02894112

Last Updated: 2016-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2015-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Oral Glucose Tolerance Test High Fat Tolerance Test

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Oral glucose tolerance test

100 g of glucose in a fruit punch flavored 8 oz drink

Group Type EXPERIMENTAL

non-fat milk

Intervention Type DIETARY_SUPPLEMENT

1 serving of non-fat fluid milk

carbohydrate control beverage

Intervention Type DIETARY_SUPPLEMENT

1 serving of carbohydrate control beverage (Carbohydrate powder + water)

caloric control beverage

Intervention Type DIETARY_SUPPLEMENT

1 serving of caloric control beverage (carbohydrate powder + protein powder + water)

High fat tolerance test

single high fat load determined by body weight.

Group Type EXPERIMENTAL

non-fat milk

Intervention Type DIETARY_SUPPLEMENT

1 serving of non-fat fluid milk

carbohydrate control beverage

Intervention Type DIETARY_SUPPLEMENT

1 serving of carbohydrate control beverage (Carbohydrate powder + water)

caloric control beverage

Intervention Type DIETARY_SUPPLEMENT

1 serving of caloric control beverage (carbohydrate powder + protein powder + water)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

non-fat milk

1 serving of non-fat fluid milk

Intervention Type DIETARY_SUPPLEMENT

carbohydrate control beverage

1 serving of carbohydrate control beverage (Carbohydrate powder + water)

Intervention Type DIETARY_SUPPLEMENT

caloric control beverage

1 serving of caloric control beverage (carbohydrate powder + protein powder + water)

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Apparently health, sedentary. All subjects will have a BMI of 25-35 kg/m2.
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Dairy Research Institute

OTHER

Sponsor Role collaborator

University of Texas at Austin

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Miriam Pearman-Leary

Doctoral Candidate

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Cardiovascular Aging Research Laboratory

Austin, Texas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1198

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Soda and Milk Study
NCT02094768 COMPLETED NA
Effect of Lactose on Blood Lipids
NCT04924530 COMPLETED NA