Dairy Fat as a Mediator of Vitamin E Adequacy in Individuals With Metabolic Syndrome
Condition: Non-alcoholic Fatty Liver; Metabolic Syndrome
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease; Metabolic Syndrome; Syndrome
Study type: Interventional

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.
    

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 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 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 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 (15 mg) with 1 cup of either 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 will be collected at timed intervals over 72 h, and plasma will be
      analyzed by liquid chromatography with mass spectrometry to determine pharmacokinetic
      parameters 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, it is expected to show that a-T
      bioavailability increases in a milk fat-dependent manner and that dairy milk compared with
      soy milk significantly improves a-T bioavailability. The results are expected to 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.
    

Intervention name(s): Fat-Free Milk; Low-Fat Milk; Full-Fat Milk; Soy Milk
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Fat-free milk ingestion with 15 mg deuterium-labeled alpha-tocopherol.; Low-fat milk ingestion with 15 mg deuterium-labeled alpha-tocopherol.; Full-fat milk ingestion with 15 mg deuterium-labeled alpha-tocopherol.; Soy milk ingestion with 15 mg deuterium-labeled alpha-tocopherol.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Vitamin E; Metabolic syndrome; Liver disease; Non-alcoholic liver steatohepatitis; Fatty liver; Dairy consumption