NCT01787591

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 6, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 8, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2013

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
12 months until next milestone

Results Posted

Study results publicly available

November 22, 2016

Completed
Last Updated

November 22, 2016

Status Verified

September 1, 2016

Enrollment Period

1.8 years

First QC Date

February 6, 2013

Results QC Date

March 24, 2016

Last Update Submit

September 30, 2016

Conditions

Non-alcoholic Fatty LiverMetabolic Syndrome

Keywords

Vitamin EMetabolic syndromeLiver diseaseNon-alcoholic liver steatohepatitisFatty liverDairy consumption

Outcome Measures

Primary Outcomes (5)

  • Area Under the Curve 0-72 h (Deuterium Labeled Alpha-tocopherol)

    0, 3, 6, 9, 12, 24, 36, 48, and 72 h post test meal

  • Cmax

    Maximal plasma concentration of deuterium labelled alpha-tocopherol

    0-72 h post-meal

  • Tmax

    Time to maximal plasma concentration of deuterium labelled alpha-tocopherol

    0-72 h post-meal

  • Elimination Rate

    Rate of plasma elimination of deuterium labelled alpha-tocopherol

    0-72 h post-meal

  • Estimated Absorption (% Dose)

    Absorption of deuterium labelled alpha-tocopherol

    0-72 h post-meal

Study Arms (4)

Acute Fat-Free Milk Ingestion

EXPERIMENTAL

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

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.

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.

Other: Full-Fat Milk

Acute Soy Milk Ingestion

EXPERIMENTAL

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

Other: Soy Milk

Interventions

Fat-Free MilkOTHER

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

Acute Fat-Free Milk Ingestion
Low-Fat MilkOTHER

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

Acute Low-Fat Milk Ingestion
Full-Fat MilkOTHER

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

Acute Full-Fat Milk Ingestion
Soy MilkOTHER

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

Acute Soy Milk Ingestion

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ohio State University

Columbus, Ohio, 43210, United States

Location

Related Publications (2)

  • 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.

    PMID: 26447154RESULT

  • 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.

    PMID: 28077381DERIVED

MeSH Terms

Conditions

Non-alcoholic Fatty Liver DiseaseMetabolic SyndromeLiver DiseasesFatty Liver

Interventions

Diet, Fat-RestrictedSoy Milk

Condition Hierarchy (Ancestors)

Digestive System DiseasesInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaMilk SubstitutesBeveragesSoy FoodsVegetable ProductsVegetablesFoodFood and Beverages

Results Point of Contact

Title
Richard S. Bruno, PhD, RD
Organization
The Ohio State University
bruno.27@osu.edu
614-292-1698

Study Officials

  • Richard Bruno, PhD, RD

    Ohio State University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 6, 2013

First Posted

February 8, 2013

Study Start

April 1, 2013

Primary Completion

January 1, 2015

Study Completion

December 1, 2015

Last Updated

November 22, 2016

Results First Posted

November 22, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will share

Data will be shared when it becomes available

Locations

US(1)