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

NCT ID: NCT01787591

Last Updated: 2016-11-22

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2015-12-31

Brief Summary

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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.

Detailed Description

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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

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Non-alcoholic Fatty Liver Metabolic Syndrome

Keywords

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Vitamin E Metabolic syndrome Liver disease Non-alcoholic liver steatohepatitis Fatty liver Dairy consumption

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Acute Fat-Free Milk Ingestion

Participants will ingest 1 cup of fat-free milk with 15 mg deuterium-labeled alpha-tocopherol.

Group Type EXPERIMENTAL

Fat-Free Milk

Intervention Type OTHER

Fat-free milk ingestion with 15 mg deuterium-labeled alpha-tocopherol.

Acute Low-Fat Milk Ingestion

Participants will ingest 1 cup of low-fat milk with 15 mg deuterium-labeled alpha-tocopherol.

Group Type EXPERIMENTAL

Low-Fat Milk

Intervention Type OTHER

Low-fat milk ingestion with 15 mg deuterium-labeled alpha-tocopherol.

Acute Full-Fat Milk Ingestion

Participants will ingest 1 cup of full-fat milk with 15 mg deuterium-labeled alpha-tocopherol.

Group Type EXPERIMENTAL

Full-Fat Milk

Intervention Type OTHER

Full-fat milk ingestion with 15 mg deuterium-labeled alpha-tocopherol.

Acute Soy Milk Ingestion

Participants will ingest 1 cup of soy milk with 15 mg deuterium-labeled alpha-tocopherol.

Group Type EXPERIMENTAL

Soy Milk

Intervention Type OTHER

Soy milk ingestion with 15 mg deuterium-labeled alpha-tocopherol.

Interventions

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Fat-Free Milk

Fat-free milk ingestion with 15 mg deuterium-labeled alpha-tocopherol.

Intervention Type OTHER

Low-Fat Milk

Low-fat milk ingestion with 15 mg deuterium-labeled alpha-tocopherol.

Intervention Type OTHER

Full-Fat Milk

Full-fat milk ingestion with 15 mg deuterium-labeled alpha-tocopherol.

Intervention Type OTHER

Soy Milk

Soy milk ingestion with 15 mg deuterium-labeled alpha-tocopherol.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ohio State University

OTHER

Sponsor Role lead

Responsible Party

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Richard Bruno

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Richard Bruno, PhD, RD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

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Ohio State University

Columbus, Ohio, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 26447154 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28077381 (View on PubMed)

Other Identifiers

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2012H0344

Identifier Type: -

Identifier Source: org_study_id