OsteoporosisNCT06265246
Impact of Milk and Yogurt Supplementation on Bone Health, Body Composition, and Gut Microbiota in Canadian Young Adults
A study testing Habitual Diet + Milk and Habitual Diet + Yogurt in people with Osteoporosis and Obesity, run by University of Saskatchewan at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis, Obesity
- What is being tested?
- Habitual Diet + Milk and Habitual Diet + Yogurt
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2024to 15 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 19-30 years old
- Dietary calcium intake below 1000mg/ day
- living in the Saskatoon area (Saskatchewan, Canada)
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Zoe Longworth, MPH contact
Canada1 site, 1 recruiting
- Recruiting
University of Saskatchewan
Saskatoon, Saskatchewan, S7N 5E5
Hassan Vatanparast
About this study
Official title: The Effects of Milk and Yogurt Supplementation on Bone Health, Body Composition, and Gut Microbiota in Canadian Young Adults: A Randomized Controlled 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.
Read the detailed description
The overarching goal of this project is to determine the role of milk and yogurt supplementation on bone health and body composition in Canadian adults aged 19 to 30 years. Both the prevalence of obesity and osteoporosis among Canadians reflect a public health concern. According to data from 2018, 27% of Canadians aged 18 and older were classified as obese, and 36% were classified as overweight. Data from 2016 revealed a diagnosis of osteoporosis for 12% of Canadians. Consumption of milk and milk products play a role in bone homeostasis over the life course but most of the research has focused on children or older adults. Dairy product intake is associated with lower body weight or body fat. However, Canadian cross-sectional data shows a decline in the consumption of dairy products among all ages from 2004 to 2015. The overall impact of dairy consumption trends is reflected in the prevalence of calcium inadequacy among Canadians. Previous studies suggest that dairy products may positively influence bone homeostasis and body composition through various mechanisms involving key nutrients and the contribution of probiotics. Young adults are in a transitional period and thus at a critical point for developing healthy lifestyle habits that support optimal body composition and maintenance of peak bone mineral density. Further, as fermented milk products contain many beneficial nutrients, determining the specific role probiotics play is difficult to define. The research will build on previous studies with a specific focus on addressing current knowledge gaps on the health impacts of young adults and the comparison between milk and yogurt.
The specific objectives of the research are:
- To examine the effects of milk and yogurt supplementation on bone mineral density (BMD), bone mineral content (BMC), bone structure, and bone geometry of Canadian adults aged 19-30 years.
- To examine the effects of milk and yogurt supplementation on hormonal indices (parathyroid hormone, Insulin-like growth factor 1, 25-hydroxyvitamin D) related to bone metabolism in Canadian adults aged 19 to 30.
- To examine the effects of milk and yogurt supplementation on biochemical indices of bone turnover (Procollagen type 1 N-propeptide, Osteocalcin, Bone alkaline phosphatase, N-terminal telopeptide of type I collagen, C-terminal telopeptide of type 1 collagen) in Canadian adults aged 19-30.
- To examine the effects of milk and fermented milk product supplementation on body composition (bone-free lean tissue mass, total body fat mass, abdominal fat mass, percent total body fat) of Canadian adults aged 19 to 30.
- To examine the effects of milk and fermented milk product supplementation on gut microbiota of Canadian adults aged 19 to 30
- Conditions
- Osteoporosis, Obesity
- Being tested
- Habitual Diet + Milk, Habitual Diet + Yogurt
- Keywords
- probiotics, cultured milk products, milk, osteoporosis, obesity, gastrointestinal microbiome, body composition, yogurt
- Medical subject headings
- Osteoporosis, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Habitual Diet + MilkOther
1.5 servings of milk [providing approx. 500 mg Ca/day] per day (either 1% fat milk, or 2% fat milk)
Habitual Diet + YogurtOther
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)
| Study group | Role | What they receive |
|---|---|---|
| Habitual Diet (Control) | No intervention | 33 participants in this arm will continue to take their usual diet without any intervention. |
| Habitual Diet + 1.5 Servings of Milk | Experimental | Not described Receives: Other: Habitual Diet + Milk |
| Habitual Diet + 2 Servings of Yogurt | Experimental | Not described Receives: Other: Habitual Diet + Yogurt |
What is being measured
The primary outcome is the main question the study is designed to answer.
Femoral neck bone mineral density
Measurement will be done via Dual Energy X-ray Absorptiometry.
Measured: Baseline, month 12, month 24
Secondary outcomes (2)
Bone mineral density (total hip, lumbar spine, whole body)
Measurement will be done via Dual Energy X-ray Absorptiometry.
Measured: Baseline, month 12, month 24
Bone mineral content (total hip, femoral neck, lumbar spine, whole body)
Measurement will be done via Dual Energy X-ray Absorptiometry.
Measured: Baseline, month 12, month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start1 Sep 2024 (estimated)
- Primary completion1 May 2027 (estimated)
- Study completion15 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In this 24-month randomized controlled trial, the investigators will follow the Consolidated Standards of Reporting Trials (CONSORT) guidelines. Ninety-nine free-living adults aged 19-30 years with low dietary calcium intake will be randomly assigned to one of the following three intervention arms. 1. Habitual diet (control) (n=33) 2. Habitual diet + 1.5 servings of milk providing approx. 500 mg Ca/day (either 1% fat milk, or 2% fat milk) (n=33) 3. Habitual diet + 2 servings of yogurt providing approx. 500 mg Ca/day (either 1% fat plain yogurt, 2% fat plain yogurt, 1% fat flavoured yogurt, 2% fat flavoured yogurt) (n=33)
- Masking
- None (open label)
- Enrolment
- 99 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Collaborators
- Dairy Farmers of Canada, Agriculture and Agri-Food Canada
- Responsible party
- Principal investigator, Hassanali Vatanparast, University of Saskatchewan
- Investigators
- Hassan Vatanparast, MD, PhD, Principal investigator, University of SaskatchewanPhil Chilibeck, PhD, Principal investigator, University of SaskatchewanSandra Clarke, Principal investigator, Agriculture and Agri-Food Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06265246
- Sponsor's protocol ID
- 104993
- Status last verified
- Aug 2024
- First submitted
- 1 Feb 2024
- Last updated
- 16 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Milk and Yogurt Supplementation on Bone Health, Body Composition, and Gut Microbiota in Canadian Young Adults: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06265246
- Acronym / sponsor ID
- 104993
- Conditions
- Osteoporosis, Obesity
- Keywords
- probiotics, cultured milk products, milk, osteoporosis, obesity, gastrointestinal microbiome, body composition, yogurt
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 99 participants (estimated)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Collaborators
- Dairy Farmers of Canada, Agriculture and Agri-Food Canada
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 15 May 2028 (estimated)
- First posted
- 20 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The overarching goal of this project is to determine the role of milk and yogurt supplementation on bone health and body composition in Canadian adults aged 19 to 30 years. Both the prevalence of obesity and osteoporosis among Canadians reflect a public health concern. According to data from 2018, 27% of Canadians aged 18 and older were classified as obese, and 36% were classified as overweight. Data from 2016 revealed a diagnosis of osteoporosis for 12% of Canadians. Consumption of milk and milk products play a role in bone homeostasis over the life course but most of the research has focused on children or older adults. Dairy product intake is associated with lower body weight or body fat. However, Canadian cross-sectional data shows a decline in the consumption of dairy products among all ages from 2004 to 2015. The overall impact of dairy consumption trends is reflected in the prevalence of calcium inadequacy among Canadians. Previous studies suggest that dairy products may positively influence bone homeostasis and body composition through various mechanisms involving key nutrients and the contribution of probiotics. Young adults are in a transitional period and thus at a critical point for developing healthy lifestyle habits that support optimal body composition and maintenance of peak bone mineral density. Further, as fermented milk products contain many beneficial nutrients, determining the specific role probiotics play is difficult to define. The research will build on previous studies with a specific focus on addressing current knowledge gaps on the health impacts of young adults and the comparison between milk and yogurt.
The specific objectives of the research are:
- To examine the effects of milk and yogurt supplementation on bone mineral density (BMD), bone mineral content (BMC), bone structure, and bone geometry of Canadian adults aged 19-30 years.
- To examine the effects of milk and yogurt supplementation on hormonal indices (parathyroid hormone, Insulin-like growth factor 1, 25-hydroxyvitamin D) related to bone metabolism in Canadian adults aged 19 to 30.
- To examine the effects of milk and yogurt supplementation on biochemical indices of bone turnover (Procollagen type 1 N-propeptide, Osteocalcin, Bone alkaline phosphatase, N-terminal telopeptide of type I collagen, C-terminal telopeptide of type 1 collagen) in Canadian adults aged 19-30.
- To examine the effects of milk and fermented milk product supplementation on body composition (bone-free lean tissue mass, total body fat mass, abdominal fat mass, percent total body fat) of Canadian adults aged 19 to 30.
- To examine the effects of milk and fermented milk product supplementation on gut microbiota of Canadian adults aged 19 to 30
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- In this 24-month randomized controlled trial, the investigators will follow the Consolidated Standards of Reporting Trials (CONSORT) guidelines. Ninety-nine free-living adults aged 19-30 years with low dietary calcium intake will be randomly assigned to one of the following three intervention arms. 1. Habitual diet (control) (n=33) 2. Habitual diet + 1.5 servings of milk providing approx. 500 mg Ca/day (either 1% fat milk, or 2% fat milk) (n=33) 3. Habitual diet + 2 servings of yogurt providing approx. 500 mg Ca/day (either 1% fat plain yogurt, 2% fat plain yogurt, 1% fat flavoured yogurt, 2% fat flavoured yogurt) (n=33)
| Arm | Type | Receives |
|---|---|---|
| Habitual Diet (Control) | No intervention | –33 participants in this arm will continue to take their usual diet without any intervention. |
| Habitual Diet + 1.5 Servings of Milk | Experimental | Other: Habitual Diet + Milk |
| Habitual Diet + 2 Servings of Yogurt | Experimental | Other: Habitual Diet + Yogurt |
Who may qualify
- Ages
- 19 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 19-30 years old
- Dietary calcium intake below 1000mg/ day
- living in the Saskatoon area (Saskatchewan, Canada)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Habitual Diet + Milk1.5 servings of milk [providing approx. 500 mg Ca/day] per day (either 1% fat milk, or 2% fat milk) | Other | Habitual Diet + 1.5 Servings of Milk |
| Habitual Diet + Yogurt2 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) | Other | Habitual Diet + 2 Servings of Yogurt |
Primary outcome
Femoral neck bone mineral density
Time frame: Baseline, month 12, month 24
Measurement will be done via Dual Energy X-ray Absorptiometry.
2 secondary outcomes
Bone mineral density (total hip, lumbar spine, whole body)
Time frame: Baseline, month 12, month 24
Bone mineral content (total hip, femoral neck, lumbar spine, whole body)
Time frame: Baseline, month 12, month 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zoe Longworth, MPH contact
Hassan Vatanparast, MD, PhD principal investigator
University of Saskatchewan
Phil Chilibeck, PhD principal investigator
University of Saskatchewan
Sandra Clarke principal investigator
Agriculture and Agri-Food Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Habitual Diet + Milk and Habitual Diet + Yogurt in people with Osteoporosis and Obesity, run by University of Saskatchewan at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hassan Vatanparast, MD, PhD (306-966-8866, vatan.h@usask.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Femoral neck bone mineral density (time frame: Baseline, month 12, month 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2024.