N/A
N=21
Dairy Fat as a Mediator of Vitamin E Adequacy in Individuals With Metabolic Syndrome
Non-alcoholic Fatty Liver · Metabolic Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT01787591 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Nov 2016
Primary outcome: Primary: Area Under the Curve 0-72 h (Deuterium Labeled Alpha-tocopherol) — 103; 115; 102; 102 umol/L x h
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Fat-Free Milk (Other); Low-Fat Milk (Other); Full-Fat Milk (Other); Soy Milk (Other)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ohio State University
- Primary completion
- Jan 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Curve 0-72 h (Deuterium Labeled Alpha-tocopherol) |
103; 115; 102; 102; 86; 84 | — |
| PRIMARY Cmax |
2.67; 2.98; 2.55; 2.67; 2.14; 2.01 | — |
| PRIMARY Tmax |
12; 12; 13.2; 12; 12; 12 | — |
| PRIMARY Elimination Rate |
0.022; 0.024; 0.023; 0.023; 0.019; 0.020 | — |
| PRIMARY Estimated Absorption (% Dose) |
27.8; 32.4; 28.4; 28.1; 26.6; 26.0 | — |
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.
Eligibility 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 ( 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 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.
Data sourced from ClinicalTrials.gov (NCT01787591). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.