Effect of Dairy Products on Insulin Resistance

NCT05421390 | Completed

• 1 other identifier: 2022-7468
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Insulin Sensitivity; Glucose Intolerance; PreDiabetes

Outcome Measures

Primary Outcomes (1)

• Change in whole-body insulin sensitivity

  Change in whole-body insulin sensitivity as measured by glucose infusion rate during the last 30 min of a hyperinsulinemic-euglycemic clamp divided by serum insulin concentration at the same period (M/I)

  Difference between baseline and 12-weeks intervention visit

Secondary Outcomes (17)

• Change in glucose tolerance

  Difference between screening and 13-week follow-up visit

• Change in Matsuda index

  Difference between screening and 13-week follow-up visit

• Change in Insulinogenic index

  Difference between screening and 13-week follow-up visit

• Change in oral disposition index

  Difference between screening and 13-week follow-up visit

• Change in Homeostatic Model Assessment for Insulin Resistance

  Difference between screening and 13-week follow-up visit

Other Outcomes (8)

• Change in resting energy expenditure

  Difference between baseline and 12-weeks intervention visit

• Change in metabolic flexibility

  Difference between baseline and 12-weeks intervention visit

• Change in total energy expenditure

  Difference between baseline and 12-weeks intervention visit

Study Arms (3)

≤1 dairy serving/day

NO INTERVENTION

Limited dairy intake

2-3 servings/day reduced-fat

EXPERIMENTAL

2-3 servings/day of skim milk, fat-free yogurt, and low-fat cheese

Other: Reduced fat dairy

2-3 servings/day regular-fat

EXPERIMENTAL

2-3 servings/day of regular-fat milk, yogurt, and cheese

Other: Regular fat dairy

Interventions

Reduced fat dairy OTHER

Serving sizes will be: 250 mL milk, 175 g yogurt, and 50 g cheese. Skim milk, fat-free yogurt, and ≤22 % fat cheese

2-3 servings/day reduced-fat

Regular fat dairy OTHER

Serving sizes will be: 250 mL milk, 175 g yogurt, and 50 g cheese. 3.25% fat milk, ≥2% fat yogurt, and ≥28% fat cheese

2-3 servings/day regular-fat

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• % HbA1c
• fasting 5.6-6.9 mmol/L glucose, or
• mmol/L glucose at 2-h OGTT

You may not qualify if:

• 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,
• Dairy allergy or lactose intolerance,
• Any diagnosed eating disorders,
• Substance abuse (drugs or alcohol \>3 drinks/day),
• Diagnosed medical conditions such as cardiovascular disease, anemia, kidney disease, liver disease and any cancer, other than skin, within 5 years.
• Diabetes diagnosis,
• Abnormal electrocardiogram or chest X-Ray,
• 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,
• Liver function tests ≥ 2× upper limit,

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead
• Dairy Farmers of Canada: collaborator

Study Sites (1)

RI-MUHC

Montreal, Quebec, H4A 3J1, Canada

Location

MeSH Terms

Conditions

Insulin Resistance; Glucose Intolerance; Prediabetic State

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hyperglycemia; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Sergio A Burgos, PhD

  RI-MUHC

  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
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 13, 2022
• First Posted: June 16, 2022
• Study Start: June 10, 2022
• Primary Completion: October 18, 2024
• Study Completion: October 18, 2024
• Last Updated: December 27, 2024

Record last verified: 2024-12

Locations

CA (1)