- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02894112
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
Status
Completed
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.
Sponsor
Collaborators
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1198
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.
Clinical Trials on Oral Glucose Tolerance Test
-
University of Missouri-ColumbiaMassachusetts Institute of TechnologyCompletedOral Glucose Tolerance Test
-
Göteborg UniversityÖrebro University, SwedenCompletedBlood Glucose | Lipid Metabolism | Oral Glucose Tolerance Test | Carbohydrate MetabolismSweden
-
University of British ColumbiaCompletedFocus of Study: Oral Tolerance Test With Glucose, Lactose, SucroseCanada
-
Hospital Universitario Dr. Jose E. GonzalezCompletedLow Birth Weight | Oral Glucose Tolerance TestMexico
-
Purdue UniversityAjinomoto USA, INC.CompletedOral Glucose ToleranceUnited States
-
University of CopenhagenCompleted
-
Clinica Universidad de Navarra, Universidad de...Instituto de Salud Carlos IIICompletedInsulin Resistance | Body Composition | Cardiovascular Risk Factor | Obesity, Abdominal | Visceral Obesity | Carbohydrate Intolerance | Beta-cell Function | Oral Glucose Tolerance Test
-
Changhai HospitalRecruitingDiabetes Mellitus | Chronic Pancreatitis | Oral Glucose Tolerance Test | Pancreatogenic Type 3C Diabetes MellitusChina
-
University of OuluCompletedGlucose ToleranceFinland
-
San Diego State UniversityRecruiting
Clinical Trials on non-fat milk
-
University of Illinois at Urbana-ChampaignRecruiting
-
Ohio State UniversityCompletedMetabolic Syndrome | Non-alcoholic Fatty LiverUnited States
-
Ohio State UniversityCompletedPrediabetesUnited States
-
University of ConnecticutCompletedGut Microbiome | Serum CholesterolUnited States
-
University of ConnecticutCompletedObesity | Cardiovascular Disease | Metabolic SyndromeUnited States
-
Instituto Nacional de Salud Publica, MexicoCompletedCardiovascular DiseasesMexico
-
NIZO Food ResearchFrieslandCampinaCompletedProtein Digestion KineticsNetherlands
-
Ministry of Food and Drug Safety, KoreaCompleted
-
University of CopenhagenThe Danish Dairy Research Foundation, Denmark; The Danish Council for Strategic...CompletedCoronary Heart Disease | Type-2 DiabetesDenmark
-
The Hospital for Sick ChildrenUnity Health TorontoRecruiting