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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19-30
SponsorUniversity of Saskatchewan

About this trial

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

This trial accepts healthy volunteers

Qualifiers

19-30 years old

Dietary calcium intake below 1000mg/ day

living in the Saskatoon area (Saskatchewan, Canada)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Habitual Diet + Milk

    Other intervention

    1.5 servings of milk \[providing approx. 500 mg Ca/day\] per day (either 1% fat milk, or 2% fat milk)

  • Habitual Diet + Yogurt

    Other intervention

    2 servings of yogurt \[providing approx. 500 mg Ca/day\] per day (either 1% fat plain yogurt, 2% fat plain yogurt, 1% fat flavoured yogurt, 2% fat flavoured yogurt)

Treatment groups

99 Participants
are divided into 3 treatment groups
Group A: Habitual Diet (Control)No intervention 0 interventions
Group B: Habitual Diet + 1.5 Servings of MilkExperimental treatment 1 intervention
Group C: Habitual Diet + 2 Servings of YogurtExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Femoral neck bone mineral density

Measurement will be done via Dual Energy X-ray Absorptiometry.

Time frame
Baseline, month 12, month 24

Secondary outcomes

1

Bone mineral density (total hip, lumbar spine, whole body)

Measurement will be done via Dual Energy X-ray Absorptiometry.

Time frame
Baseline, month 12, month 24
2

Bone mineral content (total hip, femoral neck, lumbar spine, whole body)

Measurement will be done via Dual Energy X-ray Absorptiometry.

Time frame
Baseline, month 12, month 24

Other outcomes

1

Bone structure

Measurement via HR-pQCT scan at distal radius and tibia

Time frame
Baseline, month 12, month 24
2

Bone geometry

Measurement via HR-pQCT scan at distal radius and tibia

Time frame
Baseline, month 12, month 24
3

Serum bone alkaline phosphatase (biochemical indices of bone turnover)

Fasting blood sample will be collected from each participant between 8 a.m. and 10 a.m. after an overnight fast of 12 hours with no heavy exercise/workouts 48 hours prior to blood collection into 2 x 4ml serum separating tubes (SST) for the analysis of all serum measures.

Time frame
Baseline, month 12, month 24
4

Serum osteocalcin (biochemical indices of bone turnover)

Fasting blood sample will be collected from each participant between 8 a.m. and 10 a.m. after an overnight fast of 12 hours with no heavy exercise/workouts 48 hours prior to blood collection into 2 x 4ml serum separating tubes (SST) for the analysis of all serum measures.

Time frame
Baseline, month 12, month 24

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Saskatchewan

Lead sponsor

Dairy Farmers of Canada

Collaborator

Agriculture and Agri-Food Canada

Collaborator