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Dairy and Inflammation Study

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04902417
Acronym
DRIVE
Enrollment
32
Registered
2021-05-26
Start date
2022-05-01
Completion date
2024-12-30
Last updated
2026-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiometabolic Risk, Inflammation, Overweight and Obesity

Keywords

Dairy, Diet, Inflammation, postprandial

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.

Interventions

OTHERDairy 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

Sponsors

York University
Lead SponsorOTHER
Dairy Farmers of Canada
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Intervention model description

Two-phase, randomized, controlled, crossover trial design.

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Fasting Inflammationpre-interventionConcentration of Interleukin-6
Postprandial Inflammation1 hour post mealConcentration of Interleukin-6

Secondary

MeasureTime frameDescription
Fasting Lipidspre-interventionConcentration of serum cholesterol
Fasting glucosepre-interventionConcentration of blood glucose
Fasting insulinpre-interventionConcentration of blood insulin
vascular measurespre-interventionflow-mediated dilation (FMD)
Body compositionpre-interventionfat mass (kg)

Countries

Canada

Contacts

STUDY_DIRECTORLauren E Skelly, PhD

York University

STUDY_DIRECTORJoel Prowting, MSc

York University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026