NCT01761955

Brief Summary

The purpose of this study is to evaluate the effects of regular low fat diary consumption on markers of cardiovascular (CV) and metabolic (cardiometabolic) health including body composition (% body fat, body weight), blood lipids, blood glucose, arterial compliance, blood pressure, insulin sensitivity and resting metabolic rate.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Feb 2009

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

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

February 1, 2009

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

May 22, 2012

Completed
8 months until next milestone

First Posted

Study publicly available on registry

January 7, 2013

Completed
Last Updated

January 10, 2013

Status Verified

December 1, 2008

Enrollment Period

2.2 years

First QC Date

May 22, 2012

Last Update Submit

January 9, 2013

Conditions

Keywords

body weightlipidsglucoseinsulin

Outcome Measures

Primary Outcomes (1)

  • markers of metabolic (cardiometabolic) health

    * total body composition (% body fat) * blood lipids, blood glucose * blood pressure * insulin sensitivity * resting metabolic rate

    Six Months

Study Arms (2)

High Dairy

EXPERIMENTAL

Consuming four or more servings of dairy per day.

Other: High Dairy

Control, Low Dairy

PLACEBO COMPARATOR

Participants consumed less than 2 servings of low fat dairy per day.

Interventions

Consuming 4 or more servings of dairy products per day for a period of 6 months

High Dairy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI ≥25 kg/m2, assessed as age-related healthy based on pre-study screening examination including:
  • medical history
  • diet and lifestyle history
  • physical measurements (height, weight and blood pressure).

You may not qualify if:

  • Pregnancy or likely to be pregnant (ionizing radiation from DEXA)
  • Weight ≥135kg (exceeds the capacity of the DEXA scanner)diagnosed diabetes or cardiovascular disease
  • Liver or renal disease
  • Regular use of appetite suppressants
  • Irregular use of other treatments which might interfere with the outcomes of the study (e.g anti-hypertensives, statins, thyroxine, omega-3 supplements etc).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Richardson Centre for Functional Foods and Nutraceuticals

Winnipeg, Manitoba, R3T 2N2, Canada

Location

Related Publications (1)

  • Rideout TC, Marinangeli CP, Martin H, Browne RW, Rempel CB. Consumption of low-fat dairy foods for 6 months improves insulin resistance without adversely affecting lipids or bodyweight in healthy adults: a randomized free-living cross-over study. Nutr J. 2013 May 2;12:56. doi: 10.1186/1475-2891-12-56.

MeSH Terms

Conditions

HyperlipidemiasObesityBody WeightInsulin Resistance

Condition Hierarchy (Ancestors)

DyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesOverweightOvernutritionNutrition DisordersSigns and SymptomsPathological Conditions, Signs and SymptomsHyperinsulinismGlucose Metabolism Disorders

Study Officials

  • Curtis Rempel, PhD, MBA

    University of Manitoba

    PRINCIPAL INVESTIGATOR
  • Gary Fulcher, PhD

    University of Manitoba

    STUDY CHAIR
  • Peter JH Jones, PhD

    University of Manitoba

    STUDY DIRECTOR
  • Rotimi Aluko, PhD

    University of Manitoba

    STUDY CHAIR
  • Thomas Netticadan, PhD

    University of Manitoba

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2012

First Posted

January 7, 2013

Study Start

February 1, 2009

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

January 10, 2013

Record last verified: 2008-12

Locations