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InflammationDRIVENCT04902417

Dairy and Inflammation Study

A study testing Dairy Foods (Yoghurt, Cheese, Milk) in people with Inflammation and Overweight and Obesity, run by York University at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Dairy Foods (Yoghurt, Cheese, Milk)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteCanada
Study dates
1 May 2022to 30 Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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).

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • York University

    Toronto, Ontario, M3J 1P3

Other trials in Canada

About this study

Official title: Influence of Increased Dairy Product Consumption on Markers of Inflammation and Cardiometabolic Disease

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.

Read the 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.

Being tested
Dairy Foods (Yoghurt, Cheese, Milk)
Keywords
Dairy, Diet, Inflammation, postprandial
Medical subject headings
Inflammation, Overweight, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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

Study groups in NCT04902417
Study groupRoleWhat they receive
Low Dairy Habitual DietNo interventionParticipants will follow their usual diet for 6-weeks, which includes low dairy consumption as screened for with the inclusion criteria.
High Dairy DietExperimentalParticipants 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
Receives: Other: Dairy Foods (Yoghurt, Cheese, Milk)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fasting Inflammation

    Concentration of Interleukin-6

    Measured: pre-intervention

  2. Fasting Inflammation

    Concentration of Interleukin-6

    Measured: immediately after the 6 week intervention

  3. Postprandial Inflammation

    Concentration of Interleukin-6

    Measured: 1 hour post meal

  4. Postprandial Inflammation

    Concentration of Interleukin-6

    Measured: 2 hour post meal

  5. Postprandial Inflammation

    Concentration of Interleukin-6

    Measured: 3 hour post meal

  6. Postprandial Inflammation

    Concentration of Interleukin-6

    Measured: 4 hour post meal

  7. Postprandial Inflammation

    Concentration of Interleukin-6

    Measured: 5 hour post meal

Secondary outcomes (12)

  1. Fasting Lipids

    Concentration of serum cholesterol

    Measured: pre-intervention

  2. Fasting Lipids

    Concentration of serum cholesterol

    Measured: immediately after the 6 week intervention

  3. Fasting Lipids

    Concentration of serum triglycerides

    Measured: pre-intervention

  4. Fasting Lipids

    Concentration of serum triglycerides

    Measured: immediately after the 6 week intervention

  5. Fasting glucose

    Concentration of blood glucose

    Measured: pre-intervention

  6. Fasting glucose

    Concentration of blood glucose

    Measured: immediately after the 6 week intervention

  7. Fasting insulin

    Concentration of blood insulin

    Measured: pre-intervention

  8. Fasting insulin

    Concentration of blood insulin

    Measured: immediately after the 6 week intervention

  9. vascular measures

    flow-mediated dilation (FMD)

    Measured: pre-intervention

  10. vascular measures

    flow-mediated dilation (FMD)

    Measured: immediately after the 6 week intervention

  11. Body composition

    fat mass (kg)

    Measured: pre-intervention

  12. Body composition

    fat mass (kg)

    Measured: immediately after the 6 week intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 May 2021
  2. Study start1 May 2022
  3. Primary completion30 Mar 2024
  4. Study completion30 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Model description
Two-phase, randomized, controlled, crossover trial design.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04902417
Sponsor's protocol ID
2021-177
Acronym
DRIVE
Status last verified
Jan 2026
First submitted
11 May 2021
Last updated
16 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 41176279

Questions about this trial

What is this clinical trial studying?

A study testing Dairy Foods (Yoghurt, Cheese, Milk) in people with Inflammation and Overweight and Obesity, run by York University at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fasting Inflammation (time frame: pre-intervention). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04902417, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.

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