Overview

This trial is active, not recruiting.

Conditions non-alcoholic fatty liver, metabolic syndrome
Treatments fat-free milk, low-fat milk, full-fat milk, soy milk
Sponsor Ohio State University
Start date April 2013
End date January 2015
Trial size 20 participants
Trial identifier NCT01787591, 2012H0344

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification pharmacokinetics study
Intervention model crossover assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose basic science
Arm
(Experimental)
Participants will ingest 1 cup of fat-free milk with 15 mg deuterium-labeled alpha-tocopherol.
fat-free milk
Fat-free milk ingestion with 15 mg deuterium-labeled alpha-tocopherol.
(Experimental)
Participants will ingest 1 cup of low-fat milk with 15 mg deuterium-labeled alpha-tocopherol.
low-fat milk
Low-fat milk ingestion with 15 mg deuterium-labeled alpha-tocopherol.
(Experimental)
Participants will ingest 1 cup of full-fat milk with 15 mg deuterium-labeled alpha-tocopherol.
full-fat milk
Full-fat milk ingestion with 15 mg deuterium-labeled alpha-tocopherol.
(Experimental)
Participants will ingest 1 cup of soy milk with 15 mg deuterium-labeled alpha-tocopherol.
soy milk
Soy milk ingestion with 15 mg deuterium-labeled alpha-tocopherol.

Primary Outcomes

Measure
Plasma deuterium labeled and unlabeled alpha-tocopherol
time frame: 0, 3, 6, 9, 12, 24, 36, 48, and 72 h post test meal

Secondary Outcomes

Measure
Plasma alpha-CEHC
time frame: 0, 3, 6, 9, 12, 24, 36, 48, and 72 h post test meal
Urinary alpha-CEHC
time frame: 0, 8, 16, 24 h post test meal

Eligibility Criteria

Male or female participants from 18 years up to 40 years old.

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.

Additional Information

Official title Dairy Fat as a Mediator of Vitamin E Adequacy in Individuals With Metabolic Syndrome
Principal investigator Richard Bruno, PhD, RD
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 investigators' 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 investigators' 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 investigators 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 with 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 collection will be performed using single needle sticks or cannula (for frequent blood collections) by skilled personnel. Plasma samples will be analyzed by liquid chromatography with mass spectrometry to determine pharmacokinetic parameters and vitamin E adequacy 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, the investigators expect to demonstrate that whole milk, compared to low-fat and fat-free milk, increases a-T bioavailability in a milk fat-dependent manner and that low-fat milk compared to soy milk (both beverages contain identical amounts of total fat, but differ in fatty acid profile), significantly improves a-T bioavailability. The investigators' results will 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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2015.
Information provided to ClinicalTrials.gov by Ohio State University.