Dairy Fat as a Mediator of Vitamin E Adequacy in Individuals With Metabolic Syndrome
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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 |
- Plasma deuterium labeled and unlabeled alpha-tocopherol [ Time Frame: 0, 3, 6, 9, 12, 24, 36, 48, and 72 h post test meal ] [ Designated as safety issue: No ]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.
- Plasma alpha-CEHC [ Time Frame: 0, 3, 6, 9, 12, 24, 36, 48, and 72 h post test meal ] [ Designated as safety issue: No ]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.
- Urinary alpha-CEHC [ Time Frame: 0, 8, 16, 24 h post test meal ] [ Designated as safety issue: No ]Alpha-CEHC concentrations will be assessed from urine samples collected prior to (0 h) and 8, 16, and 24 h following each test meal.
| Estimated Enrollment: | 20 |
| Study Start Date: | April 2013 |
| Estimated Study Completion Date: | February 2016 |
| Estimated Primary Completion Date: | June 2013 (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 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.
Eligibility| Ages Eligible for Study: | 18 Years to 40 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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| Contact: Eunice Mah, PhD | 6142920951 |
| United States, Ohio | |
| Ohio State University | Not yet recruiting |
| Columbus, Ohio, United States, 43210 | |
| Principal Investigator: | Richard Bruno, PhD, RD | Ohio State University |
More Information
No publications provided
| 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 |
| Last Updated: | March 11, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Ohio State University:
|
Vitamin E Metabolic syndrome Liver disease |
Non-alcoholic liver steatohepatitis Fatty liver Dairy consumption |
Additional relevant MeSH terms:
|
Fatty Liver Metabolic Syndrome X Liver Diseases Digestive System Diseases Insulin Resistance Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases Vitamin E Alpha-Tocopherol |
Tocopherols Tocotrienols Vitamins Antioxidants Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Protective Agents Physiological Effects of Drugs Micronutrients Growth Substances |
ClinicalTrials.gov processed this record on May 19, 2013