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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Richard Bruno, Ohio State University
ClinicalTrials.gov Identifier:
NCT01787591
First received: February 6, 2013
Last updated: September 30, 2016
Last verified: September 2016
  Purpose
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.

Condition Intervention
Non-alcoholic Fatty Liver
Metabolic Syndrome
Other: Fat-Free Milk
Other: Low-Fat Milk
Other: Full-Fat Milk
Other: Soy Milk

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Dairy Fat as a Mediator of Vitamin E Adequacy in Individuals With Metabolic Syndrome

Resource links provided by NLM:


Further study details as provided by Ohio State University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Cmax [ Time Frame: 0-72 h post-meal ] [ Designated as safety issue: No ]
    Maximal plasma concentration of deuterium labelled alpha-tocopherol

  • Tmax [ Time Frame: 0-72 h post-meal ] [ Designated as safety issue: No ]
    Time to maximal plasma concentration of deuterium labelled alpha-tocopherol

  • Elimination Rate [ Time Frame: 0-72 h post-meal ] [ Designated as safety issue: No ]
    Rate of plasma elimination of deuterium labelled alpha-tocopherol

  • Estimated Absorption (% Dose) [ Time Frame: 0-72 h post-meal ] [ Designated as safety issue: No ]
    Absorption of deuterium labelled alpha-tocopherol


Enrollment: 21
Study Start Date: April 2013
Study Completion Date: December 2015
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Acute Fat-Free Milk Ingestion
Participants will ingest 1 cup of fat-free milk with 15 mg deuterium-labeled alpha-tocopherol.
Other: Fat-Free Milk
Fat-free milk ingestion with 15 mg deuterium-labeled alpha-tocopherol.
Experimental: Acute Low-Fat Milk Ingestion
Participants will ingest 1 cup of low-fat milk with 15 mg deuterium-labeled alpha-tocopherol.
Other: Low-Fat Milk
Low-fat milk ingestion with 15 mg deuterium-labeled alpha-tocopherol.
Experimental: Acute Full-Fat Milk Ingestion
Participants will ingest 1 cup of full-fat milk with 15 mg deuterium-labeled alpha-tocopherol.
Other: Full-Fat Milk
Full-fat milk ingestion with 15 mg deuterium-labeled alpha-tocopherol.
Experimental: Acute Soy Milk Ingestion
Participants will ingest 1 cup of soy milk with 15 mg deuterium-labeled alpha-tocopherol.
Other: Soy Milk
Soy milk ingestion with 15 mg deuterium-labeled alpha-tocopherol.

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.
  Eligibility

Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01787591

Locations
United States, Ohio
Ohio State University
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University
Investigators
Principal Investigator: Richard Bruno, PhD, RD Ohio State University
  More Information

Publications:
Responsible Party: Richard Bruno, Associate Professor, Ohio State University
ClinicalTrials.gov Identifier: NCT01787591     History of Changes
Other Study ID Numbers: 2012H0344 
Study First Received: February 6, 2013
Results First Received: March 24, 2016
Last Updated: September 30, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: Data will be shared when it becomes available

Keywords provided by Ohio State University:
Vitamin E
Metabolic syndrome
Liver disease
Non-alcoholic liver steatohepatitis
Fatty liver
Dairy consumption

Additional relevant MeSH terms:
Syndrome
Metabolic Syndrome X
Fatty Liver
Non-alcoholic Fatty Liver Disease
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Liver Diseases
Digestive System Diseases
Vitamins
alpha-Tocopherol
Vitamin E
Tocopherols
Tocotrienols
Micronutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents

ClinicalTrials.gov processed this record on December 02, 2016