NCT02659748

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

January 15, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 20, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

October 26, 2016

Status Verified

October 1, 2016

Enrollment Period

2.3 years

First QC Date

January 15, 2016

Last Update Submit

October 24, 2016

Conditions

Insulin SensitivityType 2 Diabetes

Keywords

Bioactive fatty acidsInsulin sensitivityDietMilk fatLipid metabolismInflammation markersFecal microbiota composition

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 weeks

Secondary Outcomes (4)

  • Blood lipids

    3 weeks

  • Inflammation markers.

    3 weeks

  • Serum phospholipid analysis

    3 weeks

  • Bacterial microbiota

    3 weeks

Study Arms (2)

Milk fat

EXPERIMENTAL

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

Control Fat

EXPERIMENTAL

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

Interventions

Milk FatDIETARY_SUPPLEMENT

Three daily servings of whole yogurt (3.25% fat).

Milk fat
Control FatDIETARY_SUPPLEMENT

Three daily servings of fat-free yogurt supplemented with a control fat.

Control Fat

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Research Center, University of Vermont Medical Center

Burlington, Vermont, 05401, United States

Location

MeSH Terms

Conditions

Insulin ResistanceDiabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesDiabetes MellitusEndocrine System Diseases

Study Officials

  • Jana Kraft, PhD

    University of Vermont

    PRINCIPAL INVESTIGATOR

  • Craig L Kien, MD

    UVM Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 15, 2016

First Posted

January 20, 2016

Study Start

January 1, 2014

Primary Completion

May 1, 2016

Study Completion

December 1, 2016

Last Updated

October 26, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will share

Locations

US(1)