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Completed

NCT Number: NCT04902417

Dairy and Inflammation Study

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

York University

Toronto, Ontario, M3J 1P3, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Fasting Inflammation

    Time frame: pre-intervention

    Concentration of Interleukin-6

  2. Fasting Inflammation

    Time frame: immediately after the 6 week intervention

    Concentration of Interleukin-6

  3. Postprandial Inflammation

    Time frame: 1 hour post meal

    Concentration of Interleukin-6

  4. Postprandial Inflammation

    Time frame: 2 hour post meal

    Concentration of Interleukin-6

  5. Postprandial Inflammation

    Time frame: 3 hour post meal

    Concentration of Interleukin-6

  6. Postprandial Inflammation

    Time frame: 4 hour post meal

    Concentration of Interleukin-6

  7. Postprandial Inflammation

    Time frame: 5 hour post meal

    Concentration of Interleukin-6

Secondary outcomes

  1. Fasting Lipids

    Time frame: pre-intervention

    Concentration of serum cholesterol

  2. Fasting Lipids

    Time frame: immediately after the 6 week intervention

    Concentration of serum cholesterol

  3. Fasting Lipids

    Time frame: pre-intervention

    Concentration of serum triglycerides

  4. Fasting Lipids

    Time frame: immediately after the 6 week intervention

    Concentration of serum triglycerides

  5. Fasting glucose

    Time frame: pre-intervention

    Concentration of blood glucose

  6. Fasting glucose

    Time frame: immediately after the 6 week intervention

    Concentration of blood glucose

  7. Fasting insulin

    Time frame: pre-intervention

    Concentration of blood insulin

  8. Fasting insulin

    Time frame: immediately after the 6 week intervention

    Concentration of blood insulin

  9. vascular measures

    Time frame: pre-intervention

    flow-mediated dilation (FMD)

  10. vascular measures

    Time frame: immediately after the 6 week intervention

    flow-mediated dilation (FMD)

  11. Body composition

    Time frame: pre-intervention

    fat mass (kg)

  12. Body composition

    Time frame: immediately after the 6 week intervention

    fat mass (kg)

Sponsors and collaborators

Lead sponsor

York University

Other

Collaborators

  • Dairy Farmers of Canada

Registry information

Official study title

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

Acronym: DRIVE

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
May 26, 2021
Registry last updated
Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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