NCT00564551

Brief Summary

The purpose of this study is to determine if increased intake of low-fat milk products and calcium as part of a calorie restricted diet helps achieve a healthier body weight and body composition and decrease blood glucose levels in people with insulin resistance or type 2 diabetes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2007

Typical duration for not_applicable

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

October 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 26, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 28, 2007

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

January 21, 2010

Status Verified

January 1, 2010

Enrollment Period

1.5 years

First QC Date

November 26, 2007

Last Update Submit

January 19, 2010

Conditions

Impaired Glucose ToleranceType 2 DiabetesMetabolic Syndrome

Keywords

PrediabetesType 2 diabetesMetabolic syndromeInsulin resistance syndromeWeight lossMilk productsCalcium

Outcome Measures

Primary Outcomes (1)

  • Weight loss

    12 weeks

Secondary Outcomes (2)

  • Insulin and glucose response

    12 weeks

  • Inflammatory Markers

    12 weeks

Study Arms (2)

2

ACTIVE COMPARATOR

High dairy intake and calcium supplement. High intake of low-fat milk product intake (3-4 servings per day) plus one 350 mg calcium supplement per day during 500 kcal/day deficit diet.

Behavioral: High dairy and calcium intake

1

PLACEBO COMPARATOR

Usual diet of low dairy and calcium intake. Usual intake of low milk product intake (1 serving/day) and low calcium intake with a placebo during a 500 kcal/day deficit diet.

Behavioral: Usual intake

Interventions

High dairy and calcium intakeBEHAVIORAL

High intake of low-fat milk product intake (3-4 servings per day) plus one 350 mg calcium supplement per day during 500 kcal/day deficit diet.

Also known as: Jamieson Mega Calâ„¢ Chewable Calcium (350 mg) tablet
2
Usual intakeBEHAVIORAL

Usual intake of low milk product intake (1 serving/day) and low calcium intake with a placebo during a 500 kcal/day deficit diet

1

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Overweight and obese (BMI of 27 to 37 kg/m2)
  • Impaired glucose tolerance (fasting blood glucose \>5.6 mmol/L) or
  • Type 2 diabetes treated with diet and exercise alone (no medications)
  • One or more of the following criteria for metabolic syndrome:
  • Hypertriglyceridemia (\> 1.70 mmol/L)
  • Low high-density lipoprotein (HDL) cholesterol (\< 1.04 mmol/L in men and \< 1.30 mmol/L in women)
  • High blood pressure (\> 130/85 mm Hg)
  • High waist circumference ( \> 94 cm in men, \> 80 cm in women)
  • Weight stable and no changes in exercise in past 3 months

You may not qualify if:

  • Type 1 diabetes
  • Type 2 diabetes treated with oral hypoglycemic agents or insulin
  • HbA1c \> 8%
  • myocardial infarction or have undergone a cardiovascular intervention within the past three months
  • Subjects taking fibrate or statins who have had a dose change within the 8 weeks prior to randomization
  • Liver or pancreas disease
  • Major gastrointestinal surgeries
  • Pregnant or lactating
  • Exhibit alcohol or drug dependence
  • Taking drugs influencing appetite
  • Have a milk allergy or lactose intolerance
  • Following a diet or exercise regime designed for weight loss
  • Have a body weight greater than 350 lb (weight limit for DEXA instrument)
  • Chronic use of bulk laxatives, antacids or calcium supplements

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Kinesiology, Roger Jackson Centre for Health and Wellness Research

Calgary, Alberta, T2N 1N4, Canada

Location

MeSH Terms

Conditions

Glucose IntoleranceDiabetes Mellitus, Type 2Metabolic SyndromePrediabetic StateWeight Loss

Interventions

Tablets

Condition Hierarchy (Ancestors)

HyperglycemiaGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesDiabetes MellitusEndocrine System DiseasesInsulin ResistanceHyperinsulinismBody Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dosage FormsPharmaceutical Preparations

Study Officials

  • Raylene A. Reimer, PhD, RD

    University of Calgary

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 26, 2007

First Posted

November 28, 2007

Study Start

October 1, 2007

Primary Completion

April 1, 2009

Study Completion

October 1, 2009

Last Updated

January 21, 2010

Record last verified: 2010-01

Locations

CA(1)