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Milk Fat Intake and Metabolic Health Markers (DMFMHM)

Primary Purpose

Insulin Sensitivity, Type 2 Diabetes

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Milk Fat
Control Fat
Sponsored by
University of Vermont Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Insulin Sensitivity focused on measuring Bioactive fatty acids, Insulin sensitivity, Diet, Milk fat, Lipid metabolism, Inflammation markers, Fecal microbiota composition

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Clinical Research Center, University of Vermont Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Milk fat

Control Fat

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Insulin sensitivity
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

Blood lipids
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)),
Inflammation markers.
Plasma samples analysed using a high-sensitivity, magnetic, Luminex-based performance assay.
Serum phospholipid analysis
Serum phospholipid via SPS analyzed by gas chromatography/mass spectrometry (GC-FID).
Bacterial microbiota
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.

Full Information

First Posted
January 15, 2016
Last Updated
October 24, 2016
Sponsor
University of Vermont Medical Center
Collaborators
Dairy Research Institute, University of Vermont
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1. Study Identification

Unique Protocol Identification Number
NCT02659748
Brief Title
Milk Fat Intake and Metabolic Health Markers
Acronym
DMFMHM
Official Title
Examining the Effects of Consuming a Diet Comprising of Milk Fat on Metabolic Health Markers
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2014 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Vermont Medical Center
Collaborators
Dairy Research Institute, University of Vermont

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Sensitivity, Type 2 Diabetes
Keywords
Bioactive fatty acids, Insulin sensitivity, Diet, Milk fat, Lipid metabolism, Inflammation markers, Fecal microbiota composition

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Milk fat
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Fat
Arm Type
Experimental
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Milk Fat
Intervention Description
Three daily servings of whole yogurt (3.25% fat).
Intervention Type
Dietary Supplement
Intervention Name(s)
Control Fat
Intervention Description
Three daily servings of fat-free yogurt supplemented with a control fat.
Primary Outcome Measure Information:
Title
Insulin sensitivity
Description
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.
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Blood lipids
Description
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)),
Time Frame
3 weeks
Title
Inflammation markers.
Description
Plasma samples analysed using a high-sensitivity, magnetic, Luminex-based performance assay.
Time Frame
3 weeks
Title
Serum phospholipid analysis
Description
Serum phospholipid via SPS analyzed by gas chromatography/mass spectrometry (GC-FID).
Time Frame
3 weeks
Title
Bacterial microbiota
Description
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.
Time Frame
3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jana Kraft, PhD
Organizational Affiliation
University of Vermont
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Craig L Kien, MD
Organizational Affiliation
UVM Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Research Center, University of Vermont Medical Center
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes

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Milk Fat Intake and Metabolic Health Markers

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