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

Metabolic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01787591
• Other study ID #: 2012H0344
• Status: Active, not recruiting
• Phase: N/A
• First received: February 6, 2013
• Last updated: June 24, 2015
• Start date: April 2013
• Est. completion date: December 2016

Study information

• Verified date: June 2015
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: December 2016
• Est. primary completion date: January 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Fatty Liver
• Metabolic Syndrome
• Metabolic Syndrome X
• Non-alcoholic Fatty Liver
• Syndrome

Intervention

Other:
• Fat-Free Milk
Fat-free milk ingestion with 15 mg deuterium-labeled alpha-tocopherol.
• Low-Fat Milk
Low-fat milk ingestion with 15 mg deuterium-labeled alpha-tocopherol.
• Full-Fat Milk
Full-fat milk ingestion with 15 mg deuterium-labeled alpha-tocopherol.
• Soy Milk
Soy milk ingestion with 15 mg deuterium-labeled alpha-tocopherol.

Locations

Country	Name	City	State
United States	Ohio State University	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma deuterium labeled and unlabeled alpha-tocopherol	Plasma alpha-tocopherol concentrations will be assessed from blood samples that will be collected prior to (0 h) and at 3, 6, 9, 12, 24, 36, 48, and 72 h following each test meal.	0, 3, 6, 9, 12, 24, 36, 48, and 72 h post test meal	No
Secondary	Plasma alpha-CEHC	Alpha-CEHC concentrations will be assessed from blood samples that will be collected prior to (0 h) and at 3, 6, 9, 12, 24, 36, 48, and 72 h following each test meal.	0, 3, 6, 9, 12, 24, 36, 48, and 72 h post test meal	No
Secondary	Urinary alpha-CEHC	Alpha-CEHC concentrations will be assessed from urine samples collected prior to (0 h) and 8, 16, and 24 h following each test meal.	0, 8, 16, 24 h post test meal	No