Effect of Dairy Product Matrices on Insulin Resistance in People with Overweight and Obesity and Prediabetes

NCT06322940 | Withdrawn

• 1 other identifier: 2024-10463
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the study is to determine the effect of dairy product matrices on insulin sensitivity in overweight and obese adults with prediabetes. Females and males (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 regular-fat dairy products (milk, yogurt, or cheese). 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 to prevent 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. Adherence to intervention will be assessed at each visit by food diaries and a record of consumed dairy products.

Conditions

PreDiabetes; Overweight and Obesity

Keywords

Dairy products; Insulin sensitivity; Glucose metabolism; Insulin resistance

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)

  12 weeks

Secondary Outcomes (12)

• Change in glucose tolerance

  13 weeks

• Change in Matsuda index

  13 weeks

• Change in Insulinogenic index

  13 weeks

• Change in oral disposition index

  13 weeks

• Change in Homeostatic Model Assessment for Insulin Resistance

  13 weeks

Other Outcomes (4)

• Change in resting energy expenditure

  12 weeks

• Change in total energy expenditure

  12 weeks

• Change in metabolic equivalent of task

  12 weeks

Study Arms (3)

2-3 servings of regular-fat milk

EXPERIMENTAL

Milk

Other: 250 mL serving size, 3.25% fat content

2-3 servings of regular-fat yogurt

EXPERIMENTAL

Yogurt

Other: 175 g serving size, ≥2% fat content

2-3 servings of regular-fat cheese

EXPERIMENTAL

Cheese

Other: 50 g serving size, ≥28% fat content

Interventions

250 mL serving size, 3.25% fat content OTHER

Milk

2-3 servings of regular-fat milk

175 g serving size, ≥2% fat content OTHER

Yogurt

2-3 servings of regular-fat yogurt

50 g serving size, ≥28% fat content OTHER

Cheese

2-3 servings of regular-fat cheese

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 (assessed though questions included in the screening questionnaire regarding changes in weight and dietary habits over the past three months from the date of the screening visit),
• Body mass index of 25-40 kg/m2,
• Waist circumference will follow the International Diabetes Federation ethnic-specific definition (≥94 cm for Europid males, ≥90 cm for Asian males, ≥80 cm for females),
• One or more indicators of prediabetes:
• % HbA1c
• fasting 5.6-6.9 mmol/L glucose, or
• mmol/L glucose at 2-hour oral glucose tolerance test (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 (minerals, micronutrients, herbal remedies),
• Serum creatinine \> 120 µmol/L,
• Hemoglobin \< 120 g/L,
• Liver function tests ≥ 3× 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

Prediabetic State; Overweight; Obesity; Insulin Resistance

Interventions

Serving Size

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Sergio Burgos, PhD

  McGill University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participant's study group will be coded.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Three treatment groups

Study Record Dates

• First Submitted: February 29, 2024
• First Posted: March 21, 2024
• Study Start: September 1, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)