Dairy and Inflammation Study

NCT ID: NCT04902417

Last Updated: 2026-01-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-01
• Study Completion Date: 2024-12-30

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.

Detailed Description

Following the acquisition of informed consent, eligibility to participate in the study will be determined using questionnaires, and certain parameters determined from a finger-prick blood sample. Eligible participants will be assigned to complete two 6-week dietary interventions in random order, with at least a 4 week "wash out" period (i.e. their habitual eating) in between. The two dietary interventions are: 1) Participants normal, low-dairy diet; and 2) A higher dairy diet where 3 servings per day of dairy foods are provided. Prior to beginning either 6-week diet intervention, participants will be asked to attend the laboratory at York University after an overnight fast to undergo baseline testing.

Following baseline testing, participants will meet with a registered dietitian (RD) to discuss each diet arm. Specifically, if they are on the dairy diet, participants will receive advice on how to incorporate these dairy foods into their diet by replacing other foods of similar energy content so as to not increase their total energy intake and body weight. They will meet with the RD at several other times throughout the study. During each 6-week diet period, they will be asked to keep their physical activity levels constant and to not adopt any other major dietary changes during the study.

At the end of each 6-week intervention period, participants will be asked to return to York University to repeat the initial set of tests performed at baseline. In addition to the fasted tests, a number of tests will be performed after asking participants to consume a high-fat test meal (i.e. a fast-food breakfast). Various measurements will continue to be taken for around 6 hours after this meal is consumed.

Conditions

Inflammation; Overweight and Obesity; Cardiometabolic Risk

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Low Dairy Habitual Diet

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

High Dairy Diet

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

Group Type: EXPERIMENTAL

Dairy Foods (Yoghurt, Cheese, Milk)

Intervention Type: 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

Interventions

Dairy Foods (Yoghurt, Cheese, Milk)

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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).

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dairy Farmers of Canada

OTHER

Sponsor Role: collaborator

York University

OTHER

Sponsor Role: lead

Responsible Party

Andrea Josse

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lauren E Skelly, PhD

Role: STUDY_DIRECTOR

York University

Joel Prowting, MSc

Role: STUDY_DIRECTOR

York University

Locations

York University

Toronto, Ontario, Canada

Countries

Canada

References

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. 2025 Oct 30:S0022-3166(25)00690-X. doi: 10.1016/j.tjnut.2025.10.040. Online ahead of print.

Reference Type: DERIVED

PMID: 41176279 (View on PubMed)

Other Identifiers

2021-177

Identifier Type: -

Identifier Source: org_study_id