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NCT06265246Recruiting

Impact of Milk and Yogurt Supplementation on Bone Health, Body Composition, and Gut Microbiota in Canadian Young Adults

The Effects of Milk and Yogurt Supplementation on Bone Health, Body Composition, and Gut Microbiota in Canadian Young Adults: A Randomized Controlled Trial

Source: ClinicalTrials.gov · Last updated 16 Aug 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
99 (estimated)
First submitted
1 Feb 2024
Start date
1 Sept 2024
Primary completion date
1 May 2027
Lead sponsor
University of Saskatchewan
NCT number
NCT06265246

What you commit to

  • Study type: Interventional
  • Planned participants: 99
  • From 1 Sept 2024 to the primary completion date, 1 May 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Medical history of metabolic bone, liver, endocrine, connective tissue, and respiratory diseases, thyroid disorders, or cancer
  • 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

Lab values

  • Calcium intake from both food and supplement above the estimated average requirement (EAR) for adults aged 19-30 years (\>800 mg/day)

Other

  • Total dairy intake of more than 1 serving per day
  • Body mass index greater than to 30 kg/m2
  • Diagnosed cases with secondary osteoporosis due to hypoparathyroidism
  • Pregnant or lactating women, or those planning to conceive during the duration of the trial

Who the study is looking for

  • 19-30 years old
  • Dietary calcium intake below 1000mg/ day
  • living in the Saskatoon area (Saskatchewan, Canada)

Age in the registry: 19 years to 30 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Saskatchewan
Coordinator of this site? Confirm its status
SaskatoonCanadaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.