Oral Glucose Tolerance TestNCT02894112
Effects of Fluid Milk in Attenuating Hyperglycemia and Hypertriglyceridemia After Meal
A study testing non-fat milk in people with Oral Glucose Tolerance Test and High Fat Tolerance Test, run by University of Texas at Austin at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Glucose Tolerance Test, High Fat Tolerance Test
- What is being tested?
- non-fat milk
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Apparently health, sedentary. All subjects will have a BMI of 25-35 kg/m2.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cardiovascular Aging Research Laboratory
Austin, Texas, 78702
About this study
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.
Read the 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.
- Being tested
- non-fat milk, carbohydrate control beverage, caloric control beverage
- Keywords
- endothelial dependent vasodilation, blood flow, blood glucose, triglycerides, non-fat milk, dairy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-fat milkDietary supplement
1 serving of non-fat fluid milk
carbohydrate control beverageDietary supplement
1 serving of carbohydrate control beverage (Carbohydrate powder + water)
caloric control beverageDietary supplement
1 serving of caloric control beverage (carbohydrate powder + protein powder + water)
| Study group | Role | What they receive |
|---|---|---|
| Oral glucose tolerance test | Experimental | 100 g of glucose in a fruit punch flavored 8 oz drink Receives: Dietary Supplement: non-fat milk; Dietary Supplement: carbohydrate control beverage; Dietary Supplement: caloric control beverage |
| High fat tolerance test | Experimental | single high fat load determined by body weight. Receives: Dietary Supplement: non-fat milk; Dietary Supplement: carbohydrate control beverage; Dietary Supplement: caloric control beverage |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood glucose
Measured: 2 hour postprandially
plasma triglyceride
Measured: 4 hour postprandially
Secondary outcomes (2)
femoral artery blood flow
Measured: 2-4 hour postprandially
brachial artery flow-mediated dilation
Measured: 2-4 hour postprandially
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2016 (estimated)
- Study startApr 2013
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Glucose Tolerance TestStudies of the same condition, open and under way.
- More trials run by University of Texas at AustinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Collaborators
- Dairy Research Institute
- Responsible party
- Principal investigator, Miriam Pearman-Leary, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02894112
- Sponsor's protocol ID
- 1198
- Status last verified
- Sep 2016
- First submitted
- 30 Aug 2016
- Last updated
- 9 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Fluid Milk in Attenuating Hyperglycemia and Hypertriglyceridemia After Meal
- ClinicalTrials.gov ID
- NCT02894112
- Acronym / sponsor ID
- 1198
- Keywords
- endothelial dependent vasodilation, blood flow, blood glucose, triglycerides, non-fat milk, dairy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Collaborators
- Dairy Research Institute
- Study start
- Apr 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 9 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral glucose tolerance test | Experimental | Dietary Supplement: non-fat milk, Dietary Supplement: carbohydrate control beverage, Dietary Supplement: caloric control beverage100 g of glucose in a fruit punch flavored 8 oz drink |
| High fat tolerance test | Experimental | Dietary Supplement: non-fat milk, Dietary Supplement: carbohydrate control beverage, Dietary Supplement: caloric control beveragesingle high fat load determined by body weight. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Apparently health, sedentary. All subjects will have a BMI of 25-35 kg/m2.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| non-fat milk1 serving of non-fat fluid milk | Dietary supplement | High fat tolerance test, Oral glucose tolerance test |
| carbohydrate control beverage1 serving of carbohydrate control beverage (Carbohydrate powder + water) | Dietary supplement | High fat tolerance test, Oral glucose tolerance test |
| caloric control beverage1 serving of caloric control beverage (carbohydrate powder + protein powder + water) | Dietary supplement | High fat tolerance test, Oral glucose tolerance test |
Primary outcome
blood glucose
Time frame: 2 hour postprandially
plasma triglyceride
Time frame: 4 hour postprandially
2 secondary outcomes
femoral artery blood flow
Time frame: 2-4 hour postprandially
brachial artery flow-mediated dilation
Time frame: 2-4 hour postprandially
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing non-fat milk in people with Oral Glucose Tolerance Test and High Fat Tolerance Test, run by University of Texas at Austin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blood glucose (time frame: 2 hour postprandially). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2016.