Impaired Glucose ToleranceNCT00564551
Effect of Increased Intake of Low Fat Dairy Products on Weight Loss and Insulin Resistance
A study testing High dairy and calcium intake and Usual intake in people with Impaired Glucose Tolerance and Type 2 Diabetes, run by University of Calgary at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Impaired Glucose Tolerance, Type 2 Diabetes, Metabolic Syndrome
- What is being tested?
- High dairy and calcium intake and Usual intake
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 49 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2007to Oct 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Faculty of Kinesiology, Roger Jackson Centre for Health and Wellness Research
Calgary, Alberta, T2N 1N4
About this study
Official title: Impact of High Milk Product and Calcium Intake During Weight Loss on Markers of Insulin Resistance
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.
Read the detailed description
Obesity can cause many health problems as it is linked to several chronic diseases including type 2 diabetes. We know that individuals who are overweight or obese, and have impaired glucose tolerance or insulin resistance, have a good chance of developing type 2 diabetes. Research tells us that the risk of developing type 2 diabetes can be decreased by losing weight and making dietary changes. A promising area of study involves using low-fat milk products and calcium to prevent and/or control obesity and diabetes. This study is important because it will determine if including low-fat milk products in weight reducing diets can enhance weight loss, improve fat loss and decrease levels of blood glucose and insulin in individuals with impaired glucose tolerance or type 2 diabetes not treated with medication. This information is directly applicable to treating diseases such as obesity, type 2 diabetes and heart disease.
- Being tested
- High dairy and calcium intake, Usual intake
- Keywords
- Prediabetes, Type 2 diabetes, Metabolic syndrome, Insulin resistance syndrome, Weight loss, Milk products, Calcium
- Medical subject headings
- Glucose Intolerance, Diabetes Mellitus, Type 2, Metabolic Syndrome, Prediabetic State, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High dairy and calcium intakeBehavioural
Also called Jamieson Mega Cal™ Chewable Calcium (350 mg) tablet
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.
Usual intakeBehavioural
Usual intake of low milk product intake (1 serving/day) and low calcium intake with a placebo during a 500 kcal/day deficit diet
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Usual intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss
Measured: 12 weeks
Secondary outcomes (2)
Insulin and glucose response
Measured: 12 weeks
Inflammatory Markers
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2007 (estimated)
- Study startOct 2007
- Primary completionApr 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impaired Glucose ToleranceStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Investigators
- Raylene A. Reimer, PhD, RD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00564551
- Sponsor's protocol ID
- UC 21076
- Status last verified
- Jan 2010
- First submitted
- 26 Nov 2007
- Last updated
- 21 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of High Milk Product and Calcium Intake During Weight Loss on Markers of Insulin Resistance
- ClinicalTrials.gov ID
- NCT00564551
- Acronym / sponsor ID
- UC 21076
- Keywords
- Prediabetes, Type 2 diabetes, Metabolic syndrome, Insulin resistance syndrome, Weight loss, Milk products, Calcium
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Apr 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 28 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Obesity can cause many health problems as it is linked to several chronic diseases including type 2 diabetes. We know that individuals who are overweight or obese, and have impaired glucose tolerance or insulin resistance, have a good chance of developing type 2 diabetes. Research tells us that the risk of developing type 2 diabetes can be decreased by losing weight and making dietary changes. A promising area of study involves using low-fat milk products and calcium to prevent and/or control obesity and diabetes. This study is important because it will determine if including low-fat milk products in weight reducing diets can enhance weight loss, improve fat loss and decrease levels of blood glucose and insulin in individuals with impaired glucose tolerance or type 2 diabetes not treated with medication. This information is directly applicable to treating diseases such as obesity, type 2 diabetes and heart disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | Active comparator | Behavioral: High dairy and calcium intakeHigh 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. |
| 1 | Placebo comparator | Behavioral: Usual intakeUsual 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. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
- Weight stable and no changes in exercise in past 3 months
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High dairy and calcium intakeAlso: Jamieson Mega Cal™ Chewable Calcium (350 mg) tabletHigh 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. | Behavioural | 2 |
| Usual intakeUsual intake of low milk product intake (1 serving/day) and low calcium intake with a placebo during a 500 kcal/day deficit diet | Behavioural | 1 |
Primary outcome
Weight loss
Time frame: 12 weeks
2 secondary outcomes
Insulin and glucose response
Time frame: 12 weeks
Inflammatory Markers
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raylene A. Reimer, PhD, RD principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High dairy and calcium intake and Usual intake in people with Impaired Glucose Tolerance and Type 2 Diabetes, run by University of Calgary at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight loss (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2010.