Milk + Yogurt for Bone Health

Overseen By Hassan Vatanparast, MD, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Saskatchewan

Must not be taking: Steroids, diuretics, heparin, cancer drugs

Disqualifiers: High calcium intake, high BMI, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 24 months

99 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how milk and yogurt, rich in essential nutrients like calcium and vitamin D, affect bone health and body composition in young adults. Researchers will divide participants into three groups: one drinking milk, another eating yogurt, and a control group maintaining their usual diet. This study targets young adults in the Saskatoon area with low daily calcium intake. The findings could inform health strategies that emphasize the benefits of milk and yogurt. As an unphased trial, it offers participants the opportunity to contribute to valuable nutritional research that may enhance health recommendations.

Will I have to stop taking my current medications?

The trial requires that you do not take medications known to influence bone mass and density, such as steroids, diuretics, heparin, and cancer drugs.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that milk and yogurt are generally safe to consume and can benefit bone health. Milk contains nutrients like calcium and vitamin D, which strengthen bones. However, some studies suggest milk might have mixed effects on bone health due to certain sugars, though this remains under investigation.

Yogurt, as a fermented food, offers benefits. It contains beneficial bacteria that aid digestion and may support bone health. Concerns about harmful bacteria in yogurt are rare and typically well-managed during production.

In summary, most people can enjoy milk and yogurt without issues, though a few safety considerations relate to production methods and individual tolerance. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using milk and yogurt for bone health because these everyday foods could offer a simple and natural way to strengthen bones. Unlike standard treatments like calcium supplements or medications that often come with side effects, milk and yogurt are natural sources of calcium and vitamin D, which are essential for bone health. Adding just 1.5 servings of milk or 2 servings of yogurt to a regular diet could make bone health easier to manage and more accessible for many people. This approach emphasizes the power of dietary changes over pharmaceutical interventions, potentially offering a safer and more sustainable option for maintaining bone strength.

What evidence suggests that this trial's treatments could be effective for bone health?

This trial will compare the effects of yogurt and milk on bone health. Research has shown that yogurt and other fermented milk products might be healthier than regular milk. Some studies suggest a link between eating yogurt and a lower risk of hip fractures, but its effect on bone strength remains unclear. Participants in one arm of this trial will add two servings of yogurt to their habitual diet.

Conversely, drinking milk is usually associated with stronger bones, as it contributes to bone strength. Milk is often recommended to prevent osteoporosis, a condition where bones become weak, but its overall impact on bone health is mixed due to factors like its sugar content. Participants in another arm of this trial will add 1.5 servings of milk to their habitual diet. Both yogurt and milk contain nutrients that can support bone health, but more research is needed to fully understand their long-term effects. ^{4 5 6 7 8}

Who Is on the Research Team?

Phil Chilibeck, PhD

Principal Investigator

University of Saskatchewan

Hassan Vatanparast, MD, PhD

Principal Investigator

University of Saskatchewan

Sandra Clarke

Principal Investigator

Agriculture and Agri-Food Canada

Are You a Good Fit for This Trial?

This trial is for Canadian young adults aged 19-30 with low calcium intake, living in Saskatoon. It's designed to study the effects of milk and yogurt on bone health, body composition, and gut bacteria over two years.

Inclusion Criteria

I am between 19 and 30 years old.

Dietary calcium intake below 1000mg/day

Living in the Saskatoon area (Saskatchewan, Canada)

Exclusion Criteria

Total dairy intake of more than 1 serving per day

I have a hormonal disorder.

Cow's milk allergy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are assigned to consume either milk or yogurt daily for 24 months, or continue their habitual diet in the control group

24 months

Baseline, month 6, month 12, month 18, month 24

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Milk
• Yogurt

Trial Overview

Participants will be divided into three groups: one drinks extra milk daily, another eats more yogurt daily, and a control group continues their usual diet. The study aims to see if these dairy products improve bone density and body composition.

How Is the Trial Designed?

Group I: Habitual Diet + 2 Servings of Yogurt Experimental Treatment 1 Intervention

Group II: Habitual Diet + 1.5 Servings of Milk Experimental Treatment 1 Intervention

Group III: Habitual Diet (Control) Active Control 1 Intervention

33 participants in this arm will continue to take their usual diet without any intervention.

Milk is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Milk for:

• General nutrition
• Bone health

Approved in United States as Milk for:

• General nutrition
• Bone health

Approved in Canada as Milk for:

• General nutrition
• Bone health

Who Is Running the Clinical Trial?

University of Saskatchewan

Lead Sponsor

Trials

261

Recruited

156,000+

Agriculture and Agri-Food Canada

Collaborator

Trials

35

Recruited

2,300+

Dairy Farmers of Canada

Collaborator

Trials

33

Recruited

2,400+

Published Research Related to This Trial

In a study of 830 older adults from the Framingham Original Cohort, higher intakes of milk (more than 1 serving per week) were associated with a lower risk of hip fractures, suggesting a potential protective effect.

The results indicated that those consuming medium to high amounts of milk had a 40% lower risk of hip fractures compared to low consumers, although this association was partially influenced by bone mineral density.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protective association of milk intake on the risk of hip fracture: results from the Framingham Original Cohort. Sahni, S., Mangano, KM., Tucker, KL., et al.[2021]

In Spain, a significant portion of the population, including 20-40% of children and 30-45% of adults, consume less milk products than recommended, which are crucial for calcium intake and bone health, as they account for 44-70% of calcium consumption.

Yogurt, which is easier to digest for those with lactose maldigestion, is recommended for improving calcium absorption and may enhance the effectiveness of treatments for Helicobacter Pylori, while also reducing antibiotic-associated diarrhea.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Scientific evidence about the role of yogurt and other fermented milks in the healthy diet for the Spanish population]. Moreno Aznar, LA., Cervera Ral, P., Ortega Anta, RM., et al.[2014]

Fermented milk products like yogurt and soft cheese are rich in calcium, phosphorus, and protein, which are essential for bone growth and reducing bone loss.

These products may also contain prebiotics and probiotics that enhance calcium absorption and support bone metabolism, potentially leading to better bone health and increased compliance with dietary recommendations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Fermented Milk Products on Bone. Rizzoli, R., Biver, E.[2019]

A systematic review of seven studies indicates that vitamin D-fortified dairy products can significantly reduce the risk of osteoporotic fractures, leading to improved health outcomes such as increased life years and quality-adjusted life years.

The use of dairy products for fracture prevention is generally cost-effective, particularly for individuals over 70 years old and those over 60 years old at high risk for fractures, making it a beneficial public health strategy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A scoping review of the public health impact of vitamin D-fortified dairy products for fracture prevention. Hiligsmann, M., Neuprez, A., Buckinx, F., et al.[2018]

In a study involving 40 ovariectomized female rats, diets including milk and whey significantly improved bone mineral density and content compared to a control group, suggesting these dairy products enhance bone strength.

The changes in bone metabolism were associated with altered serum levels of vitamin D and FGF23, indicating that milk and dairy may positively influence bone health by modifying these important biomarkers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retention of bone strength by feeding of milk and dairy products in ovariectomized rats: involvement of changes in serum levels of 1alpha, 25(OH)2D3 and FGF23. Tanabe, R., Haraikawa, M., Sogabe, N., et al.[2021]

Fluid dairy intake, particularly milk and yogurt, is positively associated with hip bone mineral density (BMD), while cream may have a negative impact on BMD, indicating that not all dairy products support bone health equally.

In a study of 3,212 participants over 12 years, yogurt intake showed a weak protective trend against hip fractures, suggesting potential benefits of certain dairy products, but further research is needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Milk and yogurt consumption are linked with higher bone mineral density but not with hip fracture: the Framingham Offspring Study. Sahni, S., Tucker, KL., Kiel, DP., et al.[2021]

Milk supplementation leads to a small but significant increase in bone mineral density (BMD) at the hip and lumbar spine, suggesting it may help in preventing bone loss, based on a meta-analysis of 20 randomized controlled trials with durations ranging from 1 to 36 months.

The study found that milk supplementation reduced bone turnover markers and parathyroid hormone levels while increasing insulin-like growth factor 1, indicating a potential mechanism for how milk may support bone health by restoring bone homeostasis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of Milk Supplementation on Bone Health Indices in Adults: A Meta-Analysis of Randomized Controlled Trials. Hidayat, K., Chen, JS., Wang, TC., et al.[2023]

In a study of 4,614 older Icelandic adults, higher milk consumption was linked to a significantly lower risk of hip fractures, with a hazard ratio of 0.69 for those consuming the most milk compared to those with the least.

The research found a linear relationship between milk intake and bone health, as participants with higher milk consumption also had better bone mineral density, suggesting that milk may play a crucial role in preventing hip fractures in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Milk intake and hip fracture incidence in community-dwelling old Icelandic adults. Skuladottir, SS., Hjaltadottir, I., Launer, L., et al.[2023]

In postmenopausal women, higher yogurt consumption is linked to a significantly reduced risk of hip fractures, with a pooled relative risk of 0.76 based on data from 102,819 participants across three cohort studies.

While daily cheese intake may be associated with higher bone mineral density T-scores, the evidence is less conclusive, and no significant difference in hip fracture risk was found between higher and lower cheese consumption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fermented Milk Products and Bone Health in Postmenopausal Women: A Systematic Review of Randomized Controlled Trials, Prospective Cohorts, and Case-Control Studies. Ong, AM., Kang, K., Weiler, HA., et al.[2023]

Bedtime consumption of fermented milk significantly reduced nocturnal bone resorption in healthy postmenopausal women, as indicated by a decrease in deoxypyridinoline levels, a marker for bone breakdown.

The addition of calcium absorption enhancers (inulin-type fructans and caseinphosphopeptides) to the fermented milk improved calcium excretion, suggesting enhanced calcium absorption, although the basic fermented milk alone also had beneficial effects on bone metabolism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short-term effect of bedtime consumption of fermented milk supplemented with calcium, inulin-type fructans and caseinphosphopeptides on bone metabolism in healthy, postmenopausal women. Adolphi, B., Scholz-Ahrens, KE., de Vrese, M., et al.[2021]

Citations

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