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Dairy Products for Prediabetes
N/A
Recruiting
Led By Sergio A Burgos, PhD
Research Sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Aged between 30 and 65 years
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up difference between screening and 13-week follow-up visit
Awards & highlights
Study Summary
This trial is investigating whether consuming dairy can help improve insulin sensitivity in people with prediabetes.
Who is the study for?
This trial is for overweight or obese adults aged 30-65 with prediabetes in the Montreal area. Participants must have a certain waist size, stable weight and diet, no recent weight loss programs, and no major health issues like heart disease or diabetes. They can't be smokers, pregnant, breastfeeding, lactose intolerant or taking certain medications.Check my eligibility
What is being tested?
The study tests how different amounts of reduced-fat versus regular-fat dairy affect insulin sensitivity over 12 weeks. People will either limit their dairy intake or consume multiple servings daily while keeping their body weight constant. Insulin sensitivity will be measured using a special test before and after the diet change.See study design
What are the potential side effects?
While specific side effects are not listed for consuming reduced-fat or regular-fat dairy products in this context, individuals may experience digestive discomfort if they are sensitive to dietary changes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 30 and 65 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ difference between screening and 13-week follow-up visit
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~difference between screening and 13-week follow-up visit
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in whole-body insulin sensitivity
Secondary outcome measures
Change in C-reactive protein
Change in Homeostatic Model Assessment for Insulin Resistance
Change in Insulinogenic index
+14 moreOther outcome measures
Change in dairy fat intake biomarkers
Change in metabolic equivalent of task
Change in metabolic flexibility
+5 moreTrial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: 2-3 servings/day regular-fatExperimental Treatment1 Intervention
2-3 servings/day of regular-fat milk, yogurt, and cheese
Group II: 2-3 servings/day reduced-fatExperimental Treatment1 Intervention
2-3 servings/day of skim milk, fat-free yogurt, and low-fat cheese
Group III: ≤1 dairy serving/dayActive Control1 Intervention
Limited dairy intake
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Who is running the clinical trial?
Dairy Farmers of CanadaOTHER
31 Previous Clinical Trials
2,306 Total Patients Enrolled
McGill University Health Centre/Research Institute of the McGill University Health CentreLead Sponsor
448 Previous Clinical Trials
159,714 Total Patients Enrolled
Sergio A Burgos, PhDPrincipal InvestigatorRI-MUHC
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 30 and 65 years old.I am taking medication that could affect my blood sugar levels.People who currently smoke cigarettes.I have not joined a weight loss program in the last 3 months.Your heart test or chest X-ray shows something abnormal.I refuse to stop taking supplements like vitamin D, calcium, or herbal remedies.You have a positive test for a viral infection.You regularly use drugs or drink more than three alcoholic drinks per day.Your waist measurement is larger than 94 cm if you're a man, or larger than 80 cm if you're a woman.I have been diagnosed with an eating disorder.Your blood test shows high levels of creatinine, a waste product in the blood.You are allergic to dairy or have trouble digesting lactose.Your hemoglobin level is less than 120 grams per liter.Your blood sugar levels show signs of being close to diabetes, but not quite there yet.I have been diagnosed with diabetes.Your weight and eating habits have stayed the same for the past 3 months.I have not had heart, kidney, liver diseases, anemia, or any cancer except skin cancer in the last 5 years.I have hard-to-find veins for IVs or blood draws.You have a body mass index (BMI) between 25 and 40.Your liver function tests show more than double the normal levels.
Research Study Groups:
This trial has the following groups:- Group 1: 2-3 servings/day regular-fat
- Group 2: ≤1 dairy serving/day
- Group 3: 2-3 servings/day reduced-fat
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there any capacity to join this experiment?
"As per information on clinicaltrials.gov, this medical study is still in search of suitable candidates. It was first advertised on June 10th 2022 and has been recently revised on the 15th of the same month."
Answered by AI
Do any octogenarians qualify for this experiment?
"For this clinical trial, individuals between the ages of 30 and 65 are eligible for inclusion. In comparison, there are 38 trials which cater to those under 18 years old and 262 specifically designed for patients beyond the age of retirement."
Answered by AI
Could I potentially qualify as a participant in this scientific investigation?
"This clinical trial seeks 60 subjects, aged between 30 and 65 years old, with glucose intolerance. The potential candidates must sign informed consent forms and have a BMI in the range of 25-40 kg/m2 as well as waist circumference ≥94 cm for men or ≥80 cm for women. Furthermore, their HbA1c levels should be within 5.7-6.4%, fasting glucose should be 5.6-6.9 mmol/L and 2 hour OGTT readings should fall between 7.8-11 mmol/L after 3 months of consistent dietary habits and steady weight management"
Answered by AI
How many participants are being welcomed into this research project?
"Affirmative, clinicaltrials.gov reveals that the recruitment process for this medical trial is in progress. The study was first advertised on June 10th 2022 and most recently updated on June 15th 2022; it seeks to enrol a total of 60 patients from one site."
Answered by AI
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