PrediabetesNCT02482675

Regulation of Postprandial Nitric Oxide Bioavailability and Vascular Function By Dairy Milk

A study testing Glucose, Glucose with Non-fat Milk and Glucose with Whey Protein Isolate in people with Prediabetes, run by Ohio State University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Prediabetes
What is being tested?: Glucose, Glucose with Non-fat Milk and Glucose with Whey Protein Isolate
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 23 participants
Where: 1 siteUnited States
Study dates: Jun 2015to Feb 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 to 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

hemoglobin A1c 5.7-6.4%
non-dietary supplement user
no medications affecting vasodilation, inflammation, or energy metabolism
no CVD
nonsmokers
individuals having blood pressure <140/90 mmHg and total cholesterol <240 mg/dL

Who cannot join

unstable weight (±2 kg)
vegetarian or dairy allergy
alcohol intake >3 drinks/day or >10 drinks/week
≥7 hours/week of aerobic activity

Trial locations and contacts

1 site in 1 country.

United States1 site

The Ohio State University
Columbus, Ohio, 43210

Other trials in United States

About this study

Cardiovascular disease (CVD) is the leading cause of death in the United States. Short-term increases in blood sugar, or postprandial hyperglycemia (PPH), affect blood vessel function and increase the risk of CVD. Greater intakes of dairy foods have been associated with a lower risk of CVD, but whether these effects occur directly or indirectly by displacing foods in the diet that might increase CVD risk is unclear. The health benefits of dairy on heart health are at least partly attributed to its ability to limit PPH and resulting PPH-mediated responses leading to vascular dysfunction. This provides rationale to further investigate dairy as a dietary strategy to reduce PPH and risk for CVD. The objective of this study is to define the extent to which dairy milk, and its whey and casein protein fractions, protect against postprandial vascular dysfunction by reducing oxidative stress responses that limit nitric oxide bioavailability to the vascular endothelium in adults with prediabetes.

Read the detailed description

This study consists of four, 3-hour postprandial trials in response to consuming the following dietary treatments: 1. oral glucose challenge, 2. oral glucose challenge in combination with non-fat milk, 3. oral glucose challenge in combination with whey protein isolate, and 4. oral glucose challenge in combination with sodium caseinate. For three days preceding each trial, participants will be provided all meals to standardize physiologic responses to test meals. On each trial day, vascular function will be assessed and blood samples collected prior to and at 30 minute intervals for 3 hours following test meal ingestion.

Conditions: Prediabetes
Being tested: Glucose, Glucose with Non-fat Milk, Glucose with Whey Protein Isolate, Glucose with Sodium Caseinate
Keywords: Dairy, Milk, Glucose, Postprandial, Hyperglycemia, Prediabetes, Blood glucose, Oxidative stress, Vascular health, Vascular function
Medical subject headings: Prediabetic State, Hyperglycemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GlucoseOther
Following baseline measurements, participants will consume a 75 g glucose solution within five minutes.
Glucose with Non-fat MilkOther
Following baseline measurements, participants will consume 75 g glucose dissolved in two cups of non-fat milk within five minutes.
Glucose with Whey Protein IsolateOther
Following baseline measurements, participants will consume 75 g glucose and whey protein isolate dissolved in 2 cups water within five minutes.
Glucose with Sodium CaseinateOther
Following baseline measurements, participants will consume 75 g glucose and sodium caseinate dissolved in 2 cups water within five minutes.

Study groups in NCT02482675
Study group	Role	What they receive
Glucose	Active comparator	This study day will last approximately three hours and will be separated from the other arms by four days for men and one month for women. Receives: Other: Glucose
Glucose with Non-fat Milk	Experimental	This study day will last approximately three hours and will be separated from the other arms by four days for men and one month for women. Receives: Other: Glucose with Non-fat Milk
Glucose with Whey Protein Isolate	Experimental	This study day will last approximately three hours and will be separated from the other arms by four days for men and one month for women. Receives: Other: Glucose with Whey Protein Isolate
Glucose with Sodium Caseinate	Experimental	This study day will last approximately three hours and will be separated from the other arms by four days for men and one month for women. Receives: Other: Glucose with Sodium Caseinate

What is being measured

The primary outcome is the main question the study is designed to answer.

Vascular Endothelial Function
Flow mediated dilation (FMD) of the brachial artery, calculated as FMD AUC for 0-180 minutes (change from baseline)
Measured: Area under curve for FMD for three hours (0, 30, 60, 90, 120, 180 minutes)

Secondary outcomes (12)

Nitrite/Nitrate (NOx)
NOx AUC for 0-180 minutes
Measured: Area under curve for nitrite/nitrate for three hours (0, 30, 60, 90, 120, 180 min) (change from baseline)
Plasma Glucose
Plasma glucose concentration from 0-180 minutes
Measured: Area under the curve for glucose for three hours (0, 30, 60, 90, 120, 180 minutes) (change from baseline)
Malondialdehyde (MDA)
Plasma MDA measured as MDA AUC from 0-180 minutes
Measured: Area under curve for MDA for three hours (0, 30, 60, 90, 120, 150, 180 min.) (change from baseline)
Arginine (ARG)
Plasma arginine concentration, calculated as ARG AUC from 0-180 minutes
Measured: ARG area under the curve for 3 hours (0, 30, 60, 90, 120, 150, 180 minutes) (change from baseline)
Asymmetric Dimethylarginine/Arginine (ADMA/ARG)
Plasma ADMA/arginine concentration, calculated as ADMA/ARG AUC from 0-180 minutes
Measured: ADMA/ARG area under the curve for 3 hours (0, 30, 60, 90, 120, 150, 180 minutes) (change from baseline)
Symmetric Dimethylarginine/Arginine (SDMA/ARG)
Plasma SDMA/arginine concentration, calculated as SDMA/ARG AUC from 0-180 minutes
Measured: SDMA/ARG area under the curve for 3 hours (0, 30, 60, 90, 120, 150, 180 minutes) (change from baseline)
Tetrahydrobiopterin/Dihydrobiopterin (BH4/BH2)
Plasma BH4/BH2 concentration, calculated as BH4/BH2 AUC from 0-180 minutes
Measured: Plasma BH4/BH2 concentration area under the curve for 3 hours (0, 30, 60, 90, 120, 150, 180 minutes) (change from baseline)
Insulin
Plasma insulin concentration, calculated as insulin AUC from 0-180 minutes
Measured: Insulin area under the curve for 3 hours (0, 30, 60, 90, 120, 150, 180 minutes) (change from baseline)
Cholecystokinin (CCK)
Plasma CCK concentration, calculated as CCK AUC from 0-180 minutes
Measured: CCK area under the curve for 3 hours (0, 30, 60, 90, 120, 150, 180 minutes) (change from baseline)
8-isoprostaglandin-F2a
Plasma 8-isoprostaglandin-F2a concentration, calculated as 8-isoprostaglandin-F2a AUC from 0-180 minutes
Measured: 8-isoprostaglandin-F2a area under the curve for 3 hours (0, 30, 60, 90, 120, 150, 180 minutes) (change from baseline)
8-isoprostaglandin-F2a/Arachidonic Acid
Plasma 8-isoprostaglandin-F2a/Arachidonic acid concentration, calculated as 8-isoprostaglandin-F2a/Arachidonic acid AUC from 0-180 minutes
Measured: 8-isoprostaglandin-F2a/Arachidonic acid area under the curve for 3 hours (0, 30, 60, 90, 120, 150, 180 minutes) (change from baseline)
Arachidonic Acid
Arachidonic acid concentration, calculated as Arachidonic acid AUC from 0-180 minutes
Measured: Arachidonic acid area under the curve for 3 hours (0, 30, 60, 90, 120, 150, 180 minutes) (change from baseline)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2015Feb 2018

First posted26 Jun 2015 (estimated)
Study startJun 2015
Primary completionJul 2016
Study completionFeb 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (5)Papers the sponsor has linked to this study.
Other trials for PrediabetesStudies of the same condition, open and under way.
More trials run by Ohio State UniversityThe 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: Prevention
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 23 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02482675
Sponsor's protocol ID: 2015H0088
Status last verified: May 2019
First submitted: 24 Jun 2015
Last updated: 14 May 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Mozaffarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M, de Ferranti S, Despres JP, Fullerton HJ, Howard VJ, Huffman MD, Judd SE, Kissela BM, Lackland DT, Lichtman JH, Lisabeth LD, Liu S, Mackey RH, Matchar DB, McGuire DK, Mohler ER 3rd, Moy CS, Muntner P, Mussolino ME, Nasir K, Neumar RW, Nichol G, Palaniappan L, Pandey DK, Reeves MJ, Rodriguez CJ, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Willey JZ, Woo D, Yeh RW, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2015 update: a report from the American Heart Association. Circulation. 2015 Jan 27;131(4):e29-322. doi: 10.1161/CIR.0000000000000152. Epub 2014 Dec 17. No abstract available.
PubMed 25520374
DECODE Study Group, the European Diabetes Epidemiology Group.. Glucose tolerance and cardiovascular mortality: comparison of fasting and 2-hour diagnostic criteria. Arch Intern Med. 2001 Feb 12;161(3):397-405. doi: 10.1001/archinte.161.3.397.
PubMed 11176766
Ballard KD, Bruno RS. Protective role of dairy and its constituents on vascular function independent of blood pressure-lowering activities. Nutr Rev. 2015 Jan;73(1):36-50. doi: 10.1093/nutrit/nuu013.
PubMed 26024056
Ballard KD, Mah E, Guo Y, Pei R, Volek JS, Bruno RS. Low-fat milk ingestion prevents postprandial hyperglycemia-mediated impairments in vascular endothelial function in obese individuals with metabolic syndrome. J Nutr. 2013 Oct;143(10):1602-10. doi: 10.3945/jn.113.179465. Epub 2013 Aug 21.
PubMed 23966328
McDonald JD, Mah E, Chitchumroonchokchai C, Dey P, Labyk AN, Villamena FA, Volek JS, Bruno RS. Dairy milk proteins attenuate hyperglycemia-induced impairments in vascular endothelial function in adults with prediabetes by limiting increases in glycemia and oxidative stress that reduce nitric oxide bioavailability. J Nutr Biochem. 2019 Jan;63:165-176. doi: 10.1016/j.jnutbio.2018.09.018. Epub 2018 Sep 25.
PubMed 30412905

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Prediabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 14 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Regulation of Postprandial Nitric Oxide Bioavailability and Vascular Function By Dairy Milk
ClinicalTrials.gov ID: NCT02482675
Acronym / sponsor ID: 2015H0088
Conditions: Prediabetes
Keywords: Dairy, Milk, Glucose, Postprandial, Hyperglycemia, Prediabetes, Blood glucose, Oxidative stress
Study type: Interventional
Recruitment status: Completed
Enrolment: 23 participants (actual)
Lead sponsor: Ohio State UniversityUniversity, hospital or other
Study start: Jun 2015
Primary completion: Jul 2016 (actual)
Study completion: Feb 2018 (actual)
First posted: 26 Jun 2015 (estimated)
Results: Posted 3 May 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Glucose	Active comparator	Other: GlucoseThis study day will last approximately three hours and will be separated from the other arms by four days for men and one month for women.
Glucose with Non-fat Milk	Experimental	Other: Glucose with Non-fat MilkThis study day will last approximately three hours and will be separated from the other arms by four days for men and one month for women.
Glucose with Whey Protein Isolate	Experimental	Other: Glucose with Whey Protein IsolateThis study day will last approximately three hours and will be separated from the other arms by four days for men and one month for women.
Glucose with Sodium Caseinate	Experimental	Other: Glucose with Sodium CaseinateThis study day will last approximately three hours and will be separated from the other arms by four days for men and one month for women.

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

hemoglobin A1c 5.7-6.4%
non-dietary supplement user
no medications affecting vasodilation, inflammation, or energy metabolism
no CVD
nonsmokers

Key exclusion criteria (4 listed)

unstable weight (±2 kg)
vegetarian or dairy allergy
alcohol intake >3 drinks/day or >10 drinks/week
≥7 hours/week of aerobic activity

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
GlucoseFollowing baseline measurements, participants will consume a 75 g glucose solution within five minutes.	Other	Glucose
Glucose with Non-fat MilkFollowing baseline measurements, participants will consume 75 g glucose dissolved in two cups of non-fat milk within five minutes.	Other	Glucose with Non-fat Milk
Glucose with Whey Protein IsolateFollowing baseline measurements, participants will consume 75 g glucose and whey protein isolate dissolved in 2 cups water within five minutes.	Other	Glucose with Whey Protein Isolate
Glucose with Sodium CaseinateFollowing baseline measurements, participants will consume 75 g glucose and sodium caseinate dissolved in 2 cups water within five minutes.	Other	Glucose with Sodium Caseinate

Primary outcome

Vascular Endothelial Function
Time frame: Area under curve for FMD for three hours (0, 30, 60, 90, 120, 180 minutes)
Flow mediated dilation (FMD) of the brachial artery, calculated as FMD AUC for 0-180 minutes (change from baseline)

12 secondary outcomes

Nitrite/Nitrate (NOx)
Time frame: Area under curve for nitrite/nitrate for three hours (0, 30, 60, 90, 120, 180 min) (change from baseline)
Plasma Glucose
Time frame: Area under the curve for glucose for three hours (0, 30, 60, 90, 120, 180 minutes) (change from baseline)
Malondialdehyde (MDA)
Time frame: Area under curve for MDA for three hours (0, 30, 60, 90, 120, 150, 180 min.) (change from baseline)
Arginine (ARG)
Time frame: ARG area under the curve for 3 hours (0, 30, 60, 90, 120, 150, 180 minutes) (change from baseline)
Asymmetric Dimethylarginine/Arginine (ADMA/ARG)
Time frame: ADMA/ARG area under the curve for 3 hours (0, 30, 60, 90, 120, 150, 180 minutes) (change from baseline)
Symmetric Dimethylarginine/Arginine (SDMA/ARG)
Time frame: SDMA/ARG area under the curve for 3 hours (0, 30, 60, 90, 120, 150, 180 minutes) (change from baseline)
Tetrahydrobiopterin/Dihydrobiopterin (BH4/BH2)
Time frame: Plasma BH4/BH2 concentration area under the curve for 3 hours (0, 30, 60, 90, 120, 150, 180 minutes) (change from baseline)
Insulin
Time frame: Insulin area under the curve for 3 hours (0, 30, 60, 90, 120, 150, 180 minutes) (change from baseline)
Cholecystokinin (CCK)
Time frame: CCK area under the curve for 3 hours (0, 30, 60, 90, 120, 150, 180 minutes) (change from baseline)
8-isoprostaglandin-F2a
Time frame: 8-isoprostaglandin-F2a area under the curve for 3 hours (0, 30, 60, 90, 120, 150, 180 minutes) (change from baseline)
8-isoprostaglandin-F2a/Arachidonic Acid
Time frame: 8-isoprostaglandin-F2a/Arachidonic acid area under the curve for 3 hours (0, 30, 60, 90, 120, 150, 180 minutes) (change from baseline)
Arachidonic Acid
Time frame: Arachidonic acid area under the curve for 3 hours (0, 30, 60, 90, 120, 150, 180 minutes) (change from baseline)

Results and safety

Results posted to the registry on 3 May 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Glucose, Then Whey Protein, Then Sodium Caseinate, Then Milk	1	1
Glucose, Then Milk, Then Sodium Caseinate, Then Whey Protein	1	1
Glucose, Then Sodium Caseinate, Then Milk, Then Whey Protein	1	1
Glucose, Then Whey Protein, Then Milk, Then Sodium Caseinate	1	1
Glucose, Then Sodium Caseinate, Then Whey Protein, Then Milk	1	1
Milk, Then Glucose, Then Sodium Caseinate, Then Whey Protein	1	1
Milk, Then Whey Protein, Then Glucose, Then Sodium Caseinate	1	1
Milk, Then Whey Protein, Then Sodium Caseinate, Then Glucose	1	1
Milk, Then Sodium Caseinate, Then Whey Protein, Then Glucose	1	1
Milk, Then Glucose, Then Whey Protein, Then Sodium Caseinate	1	1
Milk, Then Sodium Caseinate, Then Glucose, Then Whey Protein	1	1
Whey Protein, Then Glucose, Then Sodium Caseinate, Then Milk	1	1
Whey Protein, Then Glucose, Then Milk, Then Sodium Caseinate	1	1
Whey Protein, Then Sodium Caseinate, Then Glucose, Then Milk	1	1
Whey Protein, Then Milk, Then Sodium Caseinate, Then Glucose	1	1
Whey Protein, Then Sodium Caseinate, Then Milk, Then Glucose	1	1
Whey Protein, Then Milk, Then Glucose, Then Sodium Caseinate	1	1
Sodium Caseinate, Then Glucose, Then Milk, Then Whey Protein	1	1
Sodium Caseinate, Then Whey Protein, Then Milk, Then Glucose	1	1
Sodium Caseinate, Then Milk, Then Glucose, Then Whey Protein	1	1
Sodium Caseinate, Then Whey Protein, Then Glucose, Then Milk	1	1
Sodium Caseinate, Then Milk, Then Whey Protein, Then Glucose	1	1
Sodium Caseinate, Then Glucose, Then Whey Protein, Then Milk	1	1

Primary outcome: Vascular Endothelial Function

Time frame: Area under curve for FMD for three hours (0, 30, 60, 90, 120, 180 minutes). Mean (Standard Error). Unit: %*min

Measure	Glucose n = 23	Glucose With Non-fat Milk n = 23	Glucose With Whey Protein Isolate n = 23	Glucose With Sodium Caseinate n = 23
Value	-307 (67.1)	-34.8 (62)	-36.8 (63.3)	-110 (49.8)

12 secondary outcomes are reported in the full results.

Adverse events

Time frame: Participants were monitored for adverse events during the entirety of the study duration (~6 total weeks).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Glucose	0 of 23 (0%)	0 of 23 (0%)	Not reported
Glucose With Non-fat Milk	0 of 23 (0%)	0 of 23 (0%)	Not reported
Glucose With Whey Protein Isolate	0 of 23 (0%)	0 of 23 (0%)	Not reported
Glucose With Sodium Caseinate	0 of 23 (0%)	0 of 23 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 25520374Mozaffarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M, de Ferranti S, Despres JP, Fullerton HJ, Howard VJ, Huffman MD, Judd SE, Kissela BM, Lackland DT, Lichtman JH, Lisabeth LD, Liu S, Mackey RH, Matchar DB, McGuire DK, Mohler ER 3rd, Moy CS, Muntner P, Mussolino ME, Nasir K, Neumar RW, Nichol G, Palaniappan L, Pandey DK, Reeves MJ, Rodriguez CJ, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Willey JZ, Woo D, Yeh RW, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2015 update: a report from the American Heart Association. Circulation. 2015 Jan 27;131(4):e29-322. doi: 10.1161/CIR.0000000000000152. Epub 2014 Dec 17. No abstract available.
Background: PubMed 11176766DECODE Study Group, the European Diabetes Epidemiology Group.. Glucose tolerance and cardiovascular mortality: comparison of fasting and 2-hour diagnostic criteria. Arch Intern Med. 2001 Feb 12;161(3):397-405. doi: 10.1001/archinte.161.3.397.
Background: PubMed 26024056Ballard KD, Bruno RS. Protective role of dairy and its constituents on vascular function independent of blood pressure-lowering activities. Nutr Rev. 2015 Jan;73(1):36-50. doi: 10.1093/nutrit/nuu013.
Background: PubMed 23966328Ballard KD, Mah E, Guo Y, Pei R, Volek JS, Bruno RS. Low-fat milk ingestion prevents postprandial hyperglycemia-mediated impairments in vascular endothelial function in obese individuals with metabolic syndrome. J Nutr. 2013 Oct;143(10):1602-10. doi: 10.3945/jn.113.179465. Epub 2013 Aug 21.
Background: PubMed 30412905McDonald JD, Mah E, Chitchumroonchokchai C, Dey P, Labyk AN, Villamena FA, Volek JS, Bruno RS. Dairy milk proteins attenuate hyperglycemia-induced impairments in vascular endothelial function in adults with prediabetes by limiting increases in glycemia and oxidative stress that reduce nitric oxide bioavailability. J Nutr Biochem. 2019 Jan;63:165-176. doi: 10.1016/j.jnutbio.2018.09.018. Epub 2018 Sep 25.

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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.

Richard S Bruno, PhD, RD principal investigator

Ohio State University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Glucose, Glucose with Non-fat Milk and Glucose with Whey Protein Isolate in people with Prediabetes, run by Ohio State University 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 6 inclusion and 4 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 14 May 2019. 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?

Yes. Results are posted in the registry (first posted 3 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Vascular Endothelial Function (time frame: Area under curve for FMD for three hours (0, 30, 60, 90, 120, 180 minutes)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02482675, which also lists 5 linked publications.

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 14 May 2019.