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Milk Fat Intake and Metabolic Health Markers (DMFMHM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02659748
Recruitment Status : Unknown
Verified October 2016 by Jana Kraft, University of Vermont.
Recruitment status was:  Active, not recruiting
First Posted : January 20, 2016
Last Update Posted : October 26, 2016
Sponsor:
Collaborators:
Dairy Research Institute
University of Vermont
Information provided by (Responsible Party):
Jana Kraft, University of Vermont

Brief Summary:
This study investigates the effects of bioactive fatty acids in full fat dairy (whole yogurt), on insulin action, calorie needs, blood lipids, immune function, and body composition in normal and overweight male and female volunteers.

Condition or disease Intervention/treatment Phase
Insulin Sensitivity Type 2 Diabetes Dietary Supplement: Milk Fat Dietary Supplement: Control Fat Not Applicable

Detailed Description:

Saturated fats impair the action of insulin leading to abnormally high blood sugar levels that are characteristic of diabetes. Since milk fat is high in saturated fat, some experts advise against whole dairy products (e.g., milk and yogurt). However, bioactive fats, such as those which occur in milk fat, may be beneficial in the prevention of diabetes.

Current data provide no compelling evidence that a moderate intake of saturated fat from milk fat increases the risk of diabetes. Milk fat contains a unique variety of bioactive fats, which may be beneficial and may counterbalance the potential negative effects of saturated fat.

The investigators hypothesize that milk fat has favorable effects on metabolic risk markers associated with the metabolic syndrome. Therefore, this study tests the hypothesis that milk-fat intake will:

(i) result in improved insulin sensitivity,

(ii) favorably alter postprandial lipid metabolism, and

(iii) result in lower circulating concentrations of pro-inflammatory markers.

This study recruits 20-24 (total) female and male subjects in a blinded, randomized, crossover design consisting of two experimental diets (3 weeks each arm) based on a DASH-like diet (Dietary Approaches to Stop Hypertension diet) with % Energy (E%): 55 E% of carbohydrate, 15 E% of protein, and 30 E% of fat (9 E% saturated fatty acids (SFA), 15 E% of monounsaturated fatty acids (MUFA), and 6 E% of polyunsaturated fatty acids (PUFA)). One experimental arm contains milk fat and the other diet contains a control fat.

A washout period represents an average US diet (48 E% of carbohydrate, 15 E% of protein and 37 E% of fat, kcal (16 E% of SFA, 14 E% of MUFA, and 7 E% of PUFA) is used to establish a level of normalization of the fatty acid intake among the subjects and to standardize the subject's physiologic state before each experimental diet.

The two experimental diets are constructed to provide three servings of dairy in the form of either 1) regular whole (full-fat, 3.25%) yogurt or 2) fat-free yogurt supplemented with a control fat. The diets are identical in terms of menus, macro- and micronutrients, and fatty acid class composition (E%) with the exception of individual bioactive fatty acids, allowing for the comparison of the bioactive milk fatty acids to non-milk fatty acids.

At the end of each period (initial washout period and each experimental diet) a frequently sampled intravenous glucose tolerance test is performed, blood is taken for fasting lipids (including lipoprotein profile), serum phospholipid fatty acid profiles, and inflammatory markers, and stool is sampled to examine the fecal microbiota composition.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Examining the Effects of Consuming a Diet Comprising of Milk Fat on Metabolic Health Markers
Study Start Date : January 2014
Actual Primary Completion Date : May 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arm Intervention/treatment
Experimental: Milk fat
A 21-day low-fat (E%) experimental diet including milk fat with macronutrient and fatty acid class profiles differing only in type of fat and, thus, the proportion of single (bioactive) fatty acids.
Dietary Supplement: Milk Fat
Three daily servings of whole yogurt (3.25% fat).

Experimental: Control Fat
A 21-day low-fat experimental diet. Eucaloric diet to Arm #1 with macronutrient and fatty acid class profiles differing only in type of fat and, thus, the proportion of single fatty acids. A control fat is used to replace dairy fats.
Dietary Supplement: Control Fat
Three daily servings of fat-free yogurt supplemented with a control fat.




Primary Outcome Measures :
  1. Insulin sensitivity [ Time Frame: 3 weeks ]
    Determined via a frequently sampled intravenous glucose tolerance test (FSIVGTT). Serum samples are analyzed in-house (glucose: glucose oxidase method; insulin: ELISA) to be used in Bergman's minimal model analysis. The results will be used to estimate insulin sensitivity.


Secondary Outcome Measures :
  1. Blood lipids [ Time Frame: 3 weeks ]
    Plasma samples analyzed by Nuclear magnetic resonance (NMR) spectroscopy and chemical lipid panel for blood lipids (triacylglycerols, cholesterol profile, including lipoprotein subclasses, lipoprotein particle sizes (Lp(a)),

  2. Inflammation markers. [ Time Frame: 3 weeks ]
    Plasma samples analysed using a high-sensitivity, magnetic, Luminex-based performance assay.

  3. Serum phospholipid analysis [ Time Frame: 3 weeks ]
    Serum phospholipid via SPS analyzed by gas chromatography/mass spectrometry (GC-FID).

  4. Bacterial microbiota [ Time Frame: 3 weeks ]
    Fecal samples collected for the analysis of intestinal bacterial composition using next-generation sequencing (Illumina Miseq V 3.1). Bacterial phyla, classes, orders, and families determined.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Good general health and not expecting major lifestyle changes while on study
  • BMI between 18.5 and 29.9 kg/m2
  • Willing to follow the study coordinator's and dietitian's instructions

Exclusion Criteria:

  • Subject with any chronic disease, inflammatory disease and previous diagnosis of HIV or hepatitis C
  • Subjects with diabetes (type 1 or 2)
  • Subjects with insulin resistance
  • Subjects who manifest metabolic syndrome based on aggregate clinical signs
  • Intolerance to dairy foods
  • Use of prescription medication (except oral contraceptives)
  • On medically prescribed diets or following a diet
  • Taking supplements that could obscure our ability to detect diet effects
  • Frequent use of over-the-counter medication
  • Habitual use of tobacco or controlled substances such as cannabis
  • Low-density lipoprotein cholesterol (LDL-C) or triacylglycerol (TAG) concentrations <5th or >95th percentile for age
  • Participation on regular basis in competitive sports or habitual aerobic exercise training, which we will arbitrarily define as consisting of > 3 bouts/wk of aerobic exercise (unable to speak comfortably) for more than 20 min
  • Women who are pregnant or lactating or planning to get pregnant
  • Allergies or significant food preferences or restrictions that would interfere with diet adherence
  • Lifestyle or schedule incompatible with the study protocol
  • Psychiatric or behavioral conditions that in the view of the principal investigator may present a safety hazard to the participant or interfere with study participation or the ability to follow the intervention protocol
  • Heart condition

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02659748


Locations
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United States, Vermont
Clinical Research Center, University of Vermont Medical Center
Burlington, Vermont, United States, 05401
Sponsors and Collaborators
University of Vermont Medical Center
Dairy Research Institute
University of Vermont
Investigators
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Principal Investigator: Jana Kraft, PhD University of Vermont
Principal Investigator: Craig L Kien, MD UVM Medical Center
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Responsible Party: Jana Kraft, Assistant Professor, University of Vermont
ClinicalTrials.gov Identifier: NCT02659748    
Other Study ID Numbers: CHRMS M14-011
1195 ( Other Grant/Funding Number: Dairy Research Institute )
First Posted: January 20, 2016    Key Record Dates
Last Update Posted: October 26, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Jana Kraft, University of Vermont:
Bioactive fatty acids
Insulin sensitivity
Diet
Milk fat
Lipid metabolism
Inflammation markers
Fecal microbiota composition
Additional relevant MeSH terms:
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Insulin Resistance
Hypersensitivity
Immune System Diseases
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases