NCT05421390Completed
Effect of Dairy Products on Insulin Resistance
Effect of Dairy Products on Insulin Resistance in Overweight and Obese Individuals With Prediabetes
Source: ClinicalTrials.gov · Last updated 11 Aug 2026
Brief summary (registry, in English)
The objective of the study is to determine the effect of dairy consumption on insulin sensitivity in overweight and obese adults with prediabetes. Men and women (30-65 y) will be recruited from the greater Montreal area. Upon screening, those with prediabetes will complete a 2-wk run-in period in which participants will consume 1 serving/d of reduced-fat dairy. Adherent participants will be randomized by sex into 1 of 3 groups: ≤1 serving/d of dairy (limited dairy) or 2-3 servings/d of reduced-fat or regular-fat dairy for 12 weeks. Participants will be instructed on how to incorporate foods into their diet in a manner that prevents changes in their body weight. The hyperinsulinemic-euglycemic clamp will be used before and after the intervention to document potential changes in insulin sensitivity as the primary outcome. In addition, glycemic variables, body composition, and cardiometabolic risk factors will be assessed as secondary outcomes. Serum lipidomic and global gene expression responses to the intervention in subcutaneous adipose tissue will be measured as exploratory variables. Adherence to intervention will be assessed at each visit by food diaries, a record of consumed dairy products, and serum proportion of 15:0, 17:0, and t16:1n7 fatty acids as objective biomarkers of dairy fat intake.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 60 (actual)
- First submitted
- 13 Jun 2022
- Start date
- 10 Jun 2022
- Primary completion date
- 18 Oct 2024
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Diseases
- Obesity
- NCT number
- NCT05421390
What you commit to
- Study type: Interventional
- Participants enrolled: 60
- From 10 Jun 2022 to the primary completion date, 18 Oct 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Substance abuse (drugs or alcohol \>3 drinks/day),
Other illness
- Dairy allergy or lactose intolerance,
- Any diagnosed eating disorders,
- Diagnosed medical conditions such as cardiovascular disease, anemia, kidney disease, liver disease and any cancer, other than skin, within 5 years.
- Diabetes diagnosis,
Lab values
- Treatment with diuretics, certain β-blockers, bronchodilators, daily nonsteroidal anti-inflammatory drugs, anticoagulants or antiplatelet agents (except prophylactic aspirin 81 mg/d), antianginals, antiarrhythmics, oral steroids, or other medications known to affect glucose metabolism,
- Refusal to temporarily stop taking supplements (vitamin D, calcium, multivitamins, herbal remedies),
- Serum creatinine \> 120 µmol/L,
- Hemoglobin \< 120 g/L,
Other
- Current smokers,
- Pregnant or planning to become pregnant in the next 6 months,
- Breastfeeding,
- Participation in a weight loss program in the past 3 months,
- Abnormal electrocardiogram or chest X-Ray,
- Liver function tests ≥ 2× upper limit,
- Positive viral serology,
- Inaccessible veins.
Who the study is looking for
- Aged between 30 and 65 years,
- Able to provide informed consent,
- Stable weight and dietary habits over a period of 3 months,
- Body mass index of 25-40 kg/m2,
- Waist circumference ≥94 cm for men, ≥80 cm for women,
- One or more indicators of prediabetes:
- 5.7-6.4% HbA1c
- fasting 5.6-6.9 mmol/L glucose, or
- 7.8-11.0 mmol/L glucose at 2-h OGTT
Age in the registry: 30 years to 65 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| RI-MUHC Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.