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

Trial Summary

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.

What data supports the effectiveness of the treatment Milk + Yogurt for Bone Health?

Research shows that consuming milk and yogurt can lower the risk of hip fractures in older adults and improve bone health in postmenopausal women by providing essential nutrients like calcium and protein, which are important for maintaining strong bones. ^{1 2 3 4 5}

Is it safe to consume milk and yogurt for bone health?

Research suggests that milk and yogurt are generally safe for bone health, as they are rich in nutrients that support bone strength and may reduce the risk of fractures. However, some studies indicate that certain components in milk might have unfavorable effects, so it's important to consider individual health conditions and consult with a healthcare provider. ^{1 3 6 7 8}

How does the Milk + Yogurt treatment for bone health differ from other treatments?

The Milk + Yogurt treatment is unique because it combines fermented milk products that are rich in calcium, phosphorus, and protein, which are essential for bone health. Additionally, yogurt contains probiotics that may enhance calcium absorption and improve gut health, offering a more holistic approach to bone health compared to other treatments. ^{2 3 6 9 10}

What is the purpose of 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.

Research Team

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

Eligibility Criteria

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

I have a hormonal disorder.

Total dairy intake of more than 1 serving per day

I consume more than 800 mg of calcium daily from food and supplements.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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 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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Milk intake and hip fracture incidence in community-dwelling old Icelandic adults. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Effects of Fermented Milk Products on Bone. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Protective association of milk intake on the risk of hip fracture: results from the Framingham Original Cohort. [2021]

4. United States 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. [2023]

5. Germany 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. [2021]

6. England 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. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

The Effects of Milk Supplementation on Bone Health Indices in Adults: A Meta-Analysis of Randomized Controlled Trials. [2023]

8. England pubmed.ncbi.nlm.nih.gov

A scoping review of the public health impact of vitamin D-fortified dairy products for fracture prevention. [2018]

9. Spain pubmed.ncbi.nlm.nih.gov

[Scientific evidence about the role of yogurt and other fermented milks in the healthy diet for the Spanish population]. [2014]

10. United States 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. [2021]