Dairy and Inflammation Study

NCT04902417 | Completed

• 1 other identifier: 2021-177
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether 6-weeks of increased dairy consumption can reduce inflammation and other markers of chronic disease while fasted or following a high-fat meal.

Conditions

Inflammation; Overweight and Obesity; Cardiometabolic Risk

Keywords

Dairy; Diet; Inflammation; postprandial

Outcome Measures

Primary Outcomes (7)

• Fasting Inflammation

  Concentration of Interleukin-6

  pre-intervention

• Fasting Inflammation

  Concentration of Interleukin-6

  immediately after the 6 week intervention

• Postprandial Inflammation

  Concentration of Interleukin-6

  1 hour post meal

• Postprandial Inflammation

  Concentration of Interleukin-6

  2 hour post meal

• Postprandial Inflammation

  Concentration of Interleukin-6

  3 hour post meal

• Postprandial Inflammation

  Concentration of Interleukin-6

  4 hour post meal

• Postprandial Inflammation

  Concentration of Interleukin-6

  5 hour post meal

Secondary Outcomes (12)

• Fasting Lipids

  pre-intervention

• Fasting Lipids

  immediately after the 6 week intervention

• Fasting Lipids

  pre-intervention

• Fasting Lipids

  immediately after the 6 week intervention

• Fasting glucose

  pre-intervention

Study Arms (2)

Low Dairy Habitual Diet

NO INTERVENTION

Participants will follow their usual diet for 6-weeks, which includes low dairy consumption as screened for with the inclusion criteria.

High Dairy Diet

EXPERIMENTAL

Participants will be provided with 3 servings of dairy per day to replace other foods within their diet (preventing weight gain over the intervention period) for 6-weeks

Other: Dairy Foods (Yoghurt, Cheese, Milk)

Interventions

Dairy Foods (Yoghurt, Cheese, Milk) OTHER

Participants will be provided with a combination of dairy products (Yoghurt, Cheese, Milk) to be consumed daily, for a total of 3 servings per day

High Dairy Diet

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Body mass index (BMI) ≥ 25 kg/m2
• ≤ 2 structured exercise sessions/week
• Habitual low dairy consumption (≤ 1 serving/day)
• Having at least two other metabolic risk factors based on clinical guidelines:
• Elevated blood pressure (≥130/≥85 mm Hg)
• Impaired fasting glucose (≥5.6 mmol/L) measured using a finger prick sample
• Impaired fasting triglycerides (≥1.7 mmol/L) or high-density lipoprotein (\<1.03 mmol/L for males, \<1.3 mmol/L for females) measured using a finger prick blood sample.
• Increased waist circumference (≥102 cm for males and ≥88 cm for females).
• Borderline high fasting low-density lipoprotein (≥3.5 mmol/L) or total cholesterol (≥5.2 mmol/L).

You may not qualify if:

• Allergy to dairy foods, diagnosed lactose intolerance or an aversion to foods provided during the study
• Previous history of diabetes and/or related cardiovascular disease
• The use of multiple medications for managing lipids, glucose and/or blood pressure

Sponsors & Collaborators

• York University: lead
• Dairy Farmers of Canada: collaborator

Study Sites (1)

York University

Toronto, Ontario, M3J 1P3, Canada

Location

Related Publications (1)

• Prowting JL, Fraschetti EC, Pereira TJ, Tucker JA, Gagnon S, Cheng N, Edgell H, Wright DC, Klentrou P, Perry CG, Josse AR. Inflammatory Cytokine Responses to 6 Wks of Increased Dairy Intake in Individuals with Overweight and Obesity-A Randomized Crossover Trial. J Nutr. 2026 Jan;156(1):101227. doi: 10.1016/j.tjnut.2025.10.040. Epub 2025 Oct 30.

  PMID: 41176279 DERIVED

MeSH Terms

Conditions

Inflammation; Overweight; Obesity

Interventions

Yogurt; Cheese; Milk

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cultured Milk Products; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Fermented Foods; Dairy Products; Food; Food and Beverages

Study Officials

• Lauren E Skelly, PhD

  York University

  STUDY DIRECTOR

• Joel Prowting, MSc

  York University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Two-phase, randomized, controlled, crossover trial design.

Study Record Dates

• First Submitted: May 11, 2021
• First Posted: May 26, 2021
• Study Start: May 1, 2022
• Primary Completion: March 30, 2024
• Study Completion: December 30, 2024
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)