Non-alcoholic Fatty LiverNCT01787591

Dairy Fat as a Mediator of Vitamin E Adequacy in Individuals With Metabolic Syndrome

A study testing Fat-Free Milk, Low-Fat Milk and Full-Fat Milk in people with Non-alcoholic Fatty Liver and Metabolic Syndrome, 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

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Trial summary

Who is it for?: Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for: Non-alcoholic Fatty Liver, Metabolic Syndrome
What is being tested?: Fat-Free Milk, Low-Fat Milk and Full-Fat Milk
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 21 participants
Where: 1 siteUnited States
Study dates: Apr 2013to Dec 2015
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 40 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

specific criteria of the metabolic syndrome: large waist circumference (>102 or >89 cm for men and women, respectively), high fasting triglycerides (150-300 mg/dL), low fasting HDL (<40 and <50 mg/dL for men and women, respectively), high blood pressure (>130/85 mm Hg) and high fasting glucose (110-180 mg/dL)
BMI: >30 kg/m2,
non-dietary supplement users for >2-mo
no use of medications known to affect lipid metabolism
no history of gastrointestinal disorders
resting blood pressure <140 mm Hg
not taking any medications that control hypertension

Who cannot join

lactose-intolerance
excessive alcohol consumption (>3 drinks/d)
>5 h/wk of aerobic activity
women who are pregnant, lactating, or have initiated or changed birth control in the past 3-mo
plasma alpha-tocopherol >20 μmol/L.

Trial locations and contacts

1 site in 1 country.

United States1 site

Ohio State University
Columbus, Ohio, 43210

Other trials in United States

About this study

This study is conducted to investigate if vitamin E status in healthy individuals and individuals with metabolic syndrome can be improved by dairy fat. The investigators hypothesize that full-fat dairy will substantially increase the bioavailability of alpha-tocopherol, a form of vitamin E. The results of this study will contribute to the application of dairy fat as a simple and effective strategy for improving vitamin E status, which is partly due to poor vitamin E intake. By completing this study, the investigators anticipate developing new dietary recommendations to achieve adequate vitamin E status through the regular consumption of dairy fat paired with foods containing vitamin E.

Read the detailed description

Nonalcoholic steatohepatitis (NASH) is the hepatic manifestation of metabolic syndrome and affects >70 million Americans. Weight loss and vitamin E supplementation are leading strategies for preventing and/or treating NASH. However, the long-term success of weight loss is limited and >92% of Americans fail to meet dietary recommendations for vitamin E. Thus, the objective is to define the extent to which dairy fat facilitates adequate vitamin E status in individuals with metabolic syndrome, a population at high-risk for NASH, by improving α-tocopherol bioavailability. The central hypothesis is that full-fat dairy will substantially increase alpha-tocopherol (a-T) bioavailability to the extent needed to facilitate production of alpha-carboxyethyl-hydroxy-chromanol (a-CEHC), a metabolite of a-T that predict a-T status. The will therefore complete the following specific aims: 1) define milk fat-mediated improvements in a-T bioavailability, and 2) define dairy fat-mediated improvements in a-T status. This study involves a randomized crossover study design where healthy adults and those with metabolic syndrome (n = 10/group) will ingest deuterium-labeled a-T (15 mg) with 1 cup of either fat-free milk, low-fat milk, whole milk, or soy milk. Urine and blood samples will be collected at timed intervals prior to and following milk consumption. Blood will be collected at timed intervals over 72 h, and plasma will be analyzed by liquid chromatography with mass spectrometry to determine pharmacokinetic parameters by measuring labeled and unlabeled a-T and a-CEHC. Risk to participants is expected to be minimal and will be outlined in the informed consent form in clear and simple terms. Upon successful completion of this study, it is expected to show that a-T bioavailability increases in a milk fat-dependent manner and that dairy milk compared with soy milk significantly improves a-T bioavailability. The results are expected to provide timely evidence demonstrating the amount and type of fat needed to achieve optimal vitamin E status specifically in a population of significant public health concern. Overall, these studies will fill a substantial knowledge gap regarding the importance of dairy fat in contributing to optimal health and provide a simple dietary approach to ameliorate poor vitamin E status among a significant proportion of Americans.

Conditions: Non-alcoholic Fatty Liver, Metabolic Syndrome
Being tested: Fat-Free Milk, Low-Fat Milk, Full-Fat Milk, Soy Milk
Keywords: Vitamin E, Metabolic syndrome, Liver disease, Non-alcoholic liver steatohepatitis, Fatty liver, Dairy consumption
Medical subject headings: Non-alcoholic Fatty Liver Disease, Metabolic Syndrome, Liver Diseases, Fatty Liver

What participants receive

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

Fat-Free MilkOther
Fat-free milk ingestion with 15 mg deuterium-labeled alpha-tocopherol.
Low-Fat MilkOther
Low-fat milk ingestion with 15 mg deuterium-labeled alpha-tocopherol.
Full-Fat MilkOther
Full-fat milk ingestion with 15 mg deuterium-labeled alpha-tocopherol.
Soy MilkOther
Soy milk ingestion with 15 mg deuterium-labeled alpha-tocopherol.

Study groups in NCT01787591
Study group	Role	What they receive
Acute Fat-Free Milk Ingestion	Experimental	Participants will ingest 1 cup of fat-free milk with 15 mg deuterium-labeled alpha-tocopherol. Receives: Other: Fat-Free Milk
Acute Low-Fat Milk Ingestion	Experimental	Participants will ingest 1 cup of low-fat milk with 15 mg deuterium-labeled alpha-tocopherol. Receives: Other: Low-Fat Milk
Acute Full-Fat Milk Ingestion	Experimental	Participants will ingest 1 cup of full-fat milk with 15 mg deuterium-labeled alpha-tocopherol. Receives: Other: Full-Fat Milk
Acute Soy Milk Ingestion	Experimental	Participants will ingest 1 cup of soy milk with 15 mg deuterium-labeled alpha-tocopherol. Receives: Other: Soy Milk

What is being measured

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

Area Under the Curve 0-72 h (Deuterium Labeled Alpha-tocopherol)
Measured: 0, 3, 6, 9, 12, 24, 36, 48, and 72 h post test meal
Cmax
Maximal plasma concentration of deuterium labelled alpha-tocopherol
Measured: 0-72 h post-meal
Tmax
Time to maximal plasma concentration of deuterium labelled alpha-tocopherol
Measured: 0-72 h post-meal
Elimination Rate
Rate of plasma elimination of deuterium labelled alpha-tocopherol
Measured: 0-72 h post-meal
Estimated Absorption (% Dose)
Absorption of deuterium labelled alpha-tocopherol
Measured: 0-72 h post-meal

Timeline

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

Apr 2013Dec 2015

First posted8 Feb 2013 (estimated)
Study startApr 2013
Primary completionJan 2015
Study completionDec 2015

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 (2)Papers the sponsor has linked to this study.
Other trials for Non-alcoholic Fatty LiverStudies 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: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 21 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01787591
Sponsor's protocol ID: 2012H0344
Status last verified: Sep 2016
First submitted: 6 Feb 2013
Last updated: 22 Nov 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Yes: Data will be shared when it becomes available

Publications

Mah E, Sapper TN, Chitchumroonchokchai C, Failla ML, Schill KE, Clinton SK, Bobe G, Traber MG, Bruno RS. alpha-Tocopherol bioavailability is lower in adults with metabolic syndrome regardless of dairy fat co-ingestion: a randomized, double-blind, crossover trial. Am J Clin Nutr. 2015 Nov;102(5):1070-80. doi: 10.3945/ajcn.115.118570. Epub 2015 Oct 7.
PubMed 26447154
Traber MG, Mah E, Leonard SW, Bobe G, Bruno RS. Metabolic syndrome increases dietary alpha-tocopherol requirements as assessed using urinary and plasma vitamin E catabolites: a double-blind, crossover clinical trial. Am J Clin Nutr. 2017 Mar;105(3):571-579. doi: 10.3945/ajcn.116.138495. Epub 2017 Jan 11.
PubMed 28077381

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?

See locations

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All Non-alcoholic Fatty Liver trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Dairy Fat as a Mediator of Vitamin E Adequacy in Individuals With Metabolic Syndrome
ClinicalTrials.gov ID: NCT01787591
Acronym / sponsor ID: 2012H0344
Conditions: Non-alcoholic Fatty Liver, Metabolic Syndrome
Keywords: Vitamin E, Metabolic syndrome, Liver disease, Non-alcoholic liver steatohepatitis, Fatty liver, Dairy consumption
Study type: Interventional
Recruitment status: Completed
Enrolment: 21 participants (actual)
Lead sponsor: Ohio State UniversityUniversity, hospital or other
Study start: Apr 2013
Primary completion: Jan 2015 (actual)
Study completion: Dec 2015 (actual)
First posted: 8 Feb 2013 (estimated)
Results: Posted 22 Nov 2016

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: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Acute Fat-Free Milk Ingestion	Experimental	Other: Fat-Free MilkParticipants will ingest 1 cup of fat-free milk with 15 mg deuterium-labeled alpha-tocopherol.
Acute Low-Fat Milk Ingestion	Experimental	Other: Low-Fat MilkParticipants will ingest 1 cup of low-fat milk with 15 mg deuterium-labeled alpha-tocopherol.
Acute Full-Fat Milk Ingestion	Experimental	Other: Full-Fat MilkParticipants will ingest 1 cup of full-fat milk with 15 mg deuterium-labeled alpha-tocopherol.
Acute Soy Milk Ingestion	Experimental	Other: Soy MilkParticipants will ingest 1 cup of soy milk with 15 mg deuterium-labeled alpha-tocopherol.

Who may qualify

Ages: 18 to 40 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (7 listed)

specific criteria of the metabolic syndrome: large waist circumference (>102 or >89 cm for men and women, respectively), high fasting triglycerides (150-300 mg/dL), low fasting HDL (<40 and <50 mg/dL for men and women, respectively), high blood pressure (>130/85 mm Hg) and high fasting glucose (110-180 mg/dL)
BMI: >30 kg/m2,
non-dietary supplement users for >2-mo
no use of medications known to affect lipid metabolism
no history of gastrointestinal disorders

Key exclusion criteria (5 listed)

lactose-intolerance
excessive alcohol consumption (>3 drinks/d)
>5 h/wk of aerobic activity
women who are pregnant, lactating, or have initiated or changed birth control in the past 3-mo
plasma alpha-tocopherol >20 μmol/L.

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
Fat-Free MilkFat-free milk ingestion with 15 mg deuterium-labeled alpha-tocopherol.	Other	Acute Fat-Free Milk Ingestion
Low-Fat MilkLow-fat milk ingestion with 15 mg deuterium-labeled alpha-tocopherol.	Other	Acute Low-Fat Milk Ingestion
Full-Fat MilkFull-fat milk ingestion with 15 mg deuterium-labeled alpha-tocopherol.	Other	Acute Full-Fat Milk Ingestion
Soy MilkSoy milk ingestion with 15 mg deuterium-labeled alpha-tocopherol.	Other	Acute Soy Milk Ingestion

Primary outcome

Area Under the Curve 0-72 h (Deuterium Labeled Alpha-tocopherol)
Time frame: 0, 3, 6, 9, 12, 24, 36, 48, and 72 h post test meal
Cmax
Time frame: 0-72 h post-meal
Maximal plasma concentration of deuterium labelled alpha-tocopherol
Tmax
Time frame: 0-72 h post-meal
Time to maximal plasma concentration of deuterium labelled alpha-tocopherol
Elimination Rate
Time frame: 0-72 h post-meal
Rate of plasma elimination of deuterium labelled alpha-tocopherol
Estimated Absorption (% Dose)
Time frame: 0-72 h post-meal
Absorption of deuterium labelled alpha-tocopherol

Results and safety

Results posted to the registry on 22 Nov 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Acute Fat-Free Milk Ingestion First	5	5
Acute Low-Fat Milk Ingestion First	5	5
Acute Full-Fat Milk Ingestion First	5	5
Acute Soy Milk Ingestion First	6	5

Primary outcome: Area Under the Curve 0-72 h (Deuterium Labeled Alpha-tocopherol)

Time frame: 0, 3, 6, 9, 12, 24, 36, 48, and 72 h post test meal. Mean (Standard Error). Unit: umol/L x h

Measure	Acute Fat-Free Milk Ingestion n = 20	Acute Low-Fat Milk Ingestion n = 20	Acute Full-Fat Milk Ingestion n = 20	Acute Soy Milk Ingestion n = 20
Healthy Participants	103 (7)	115 (8)	102 (8)	102 (5)
Metabolic Syndrome Participants	86 (8)	84 (7)	81 (7)	74 (11)

Primary outcome: Cmax

Time frame: 0-72 h post-meal. Mean (Standard Error). Unit: umol/L

Measure	Acute Fat-Free Milk Ingestion n = 20	Acute Low-Fat Milk Ingestion n = 20	Acute Full-Fat Milk Ingestion n = 20	Acute Soy Milk Ingestion n = 20
Healthy	2.67 (0.2)	2.98 (0.18)	2.55 (0.21)	2.67 (0.13)
Metabolic Syndrome	2.14 (0.2)	2.01 (0.19)	1.98 (0.16)	1.88 (0.27)

Primary outcome: Tmax

Time frame: 0-72 h post-meal. Mean (Standard Error). Unit: h

Measure	Acute Fat-Free Milk Ingestion n = 20	Acute Low-Fat Milk Ingestion n = 20	Acute Full-Fat Milk Ingestion n = 20	Acute Soy Milk Ingestion n = 20
Healthy	12 (0)	12 (0)	13.2 (1.2)	12 (0)
Metabolic Syndrome	12 (0)	12 (0)	12 (0)	12 (0)

Primary outcome: Elimination Rate

Time frame: 0-72 h post-meal. Mean (Standard Error). Unit: mmol/L/h

Measure	Acute Fat-Free Milk Ingestion n = 20	Acute Low-Fat Milk Ingestion n = 20	Acute Full-Fat Milk Ingestion n = 20	Acute Soy Milk Ingestion n = 20
Healthy	0.022 (0.001)	0.024 (0.001)	0.023 (0.001)	0.023 (0.001)
Metabolic Syndrome	0.019 (0.001)	0.020 (0.001)	0.021 (0.001)	0.022 (0.001)

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Acute Fat-Free Milk Ingestion	0 of 20 (0%)	0 of 20 (0%)	Not reported
Acute Low-Fat Milk Ingestion	0 of 20 (0%)	0 of 20 (0%)	Not reported
Acute Full-Fat Milk Ingestion	0 of 20 (0%)	0 of 20 (0%)	Not reported
Acute Soy Milk Ingestion	0 of 20 (0%)	0 of 20 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 26447154Mah E, Sapper TN, Chitchumroonchokchai C, Failla ML, Schill KE, Clinton SK, Bobe G, Traber MG, Bruno RS. alpha-Tocopherol bioavailability is lower in adults with metabolic syndrome regardless of dairy fat co-ingestion: a randomized, double-blind, crossover trial. Am J Clin Nutr. 2015 Nov;102(5):1070-80. doi: 10.3945/ajcn.115.118570. Epub 2015 Oct 7.
Derived from this study: PubMed 28077381Traber MG, Mah E, Leonard SW, Bobe G, Bruno RS. Metabolic syndrome increases dietary alpha-tocopherol requirements as assessed using urinary and plasma vitamin E catabolites: a double-blind, crossover clinical trial. Am J Clin Nutr. 2017 Mar;105(3):571-579. doi: 10.3945/ajcn.116.138495. Epub 2017 Jan 11.
Individual participant dataSharing planned: Yes. Data will be shared when it becomes available

Related trials for Non-alcoholic Fatty Liver

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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 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 Fat-Free Milk, Low-Fat Milk and Full-Fat Milk in people with Non-alcoholic Fatty Liver and Metabolic Syndrome, 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 7 inclusion and 5 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 22 Nov 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?

Yes. Results are posted in the registry (first posted 22 Nov 2016). 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?

Area Under the Curve 0-72 h (Deuterium Labeled Alpha-tocopherol) (time frame: 0, 3, 6, 9, 12, 24, 36, 48, and 72 h post test meal). The study lists 5 primary outcomes in all. 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 NCT01787591, which also lists 2 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 22 Nov 2016.