NCT06265246 Impact of Milk and Yogurt Supplementation on Bone Health, Body Composition, and Gut Microbiota in Canadian Young Adults
| NCT ID | NCT06265246 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Saskatchewan |
| Condition | Osteoporosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 99 participants |
| Start Date | 2024-09-01 |
| Primary Completion | 2027-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 99 participants in total. It began in 2024-09-01 with a primary completion date of 2027-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Milk and dairy products contain significant amounts of nutrients that contribute to optimal health - nutrients like calcium, vitamin D, and high-quality protein. Fermented milk products or fermented dairy products are dairy foods that have been fermented with certain bacteria. Yogurt is a fermented dairy product containing millions of beneficial bacteria. In this study, the invesgitagtors will look at the effect of milk (a non-fermented dairy product) and yogurt (a fermented dairy product) supplementation on bone health and the amount of fat and muscle mass in Canadian young adults over a 24-month period. While dairy products contain significant amounts of nutrients, the scientific community does not know the impact of long-term supplementation of fermented (i.e., yogurt) or non-fermented (i.e., milk) dairy food on bone health and the amount of fat and muscle mass in young adults. To fill this knowledge gap, the investigators will recruit participants with low calcium intake and assign them to three different groups: 1) milk (intervention) group; 2) yogurt (intervention) group; and 3) control group. The investigators will ask the participants in the milk group to drink 1.5 servings (375 mL) of milk per day for 24 months. Participants in the yogurt group will consume 2 servings (350 g) of yogurt per day for 24 months. Those in the control group will continue their usual diets. Using a randomized controlled trial design, the investigators will measure bone health parameters, hormonal indices related to bone metabolism, body composition (e.g., muscle mass, fat mass), and the number and composition of bacteria living in the gastrointestinal (GI) tract. The hypothesis is that supplementation with yogurt will have more positive effects on bone health indices, particularly femoral neck BMD as the primary outcome, than milk in Canadian adults aged 19-30 years. The secondary hypothesis is that supplementation with yogurt, as a fermented milk product, will have a more beneficial effect than milk on body composition measures. The data will provide valuable information for developing targeted health initiatives and marketing strategies regarding the benefits of fermented and non-fermented dairy product consumption.
Eligibility Criteria
Inclusion Criteria: * 19-30 years old * Dietary calcium intake below 1000mg/ day * living in the Saskatoon area (Saskatchewan, Canada) Exclusion Criteria: * Calcium intake from both food and supplement above the estimated average requirement (EAR) for adults aged 19-30 years (\>800 mg/day) * Total dairy intake of more than 1 serving per day * Body mass index greater than to 30 kg/m2 * Medical history of metabolic bone, liver, endocrine, connective tissue, and respiratory diseases, thyroid disorders, or cancer * Diagnosed cases with secondary osteoporosis due to hypoparathyroidism * Hormonal disorders or disturbances * Taking medications known to influence bone mass and density (e.g., steroids, diuretics, heparin, and cancer drugs) * Cow's milk allergy * Pregnant or lactating women, or those planning to conceive during the duration of the trial
Contact & Investigator
Hassan Vatanparast, MD, PhD
PRINCIPAL INVESTIGATOR
University of Saskatchewan
Frequently Asked Questions
Who can join the NCT06265246 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, up to 30 Years, studying Osteoporosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06265246 currently recruiting?
Yes, NCT06265246 is actively recruiting participants. Contact the research team at vatan.h@usask.ca for enrollment information.
Where is the NCT06265246 trial being conducted?
This trial is being conducted at Saskatoon, Canada.
Who is sponsoring the NCT06265246 clinical trial?
NCT06265246 is sponsored by University of Saskatchewan. The principal investigator is Hassan Vatanparast, MD, PhD at University of Saskatchewan. The trial plans to enroll 99 participants.