Age: 18 - 65
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Saskatchewan
No Placebo Group
Trial Summary
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.
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.
23457Is 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.
356910What 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.
157810Will 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.
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.
Exclusion Criteria
I consume more than 800 mg of calcium daily from food and supplements.
My osteoporosis is caused by hypoparathyroidism.
Participant Groups
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.
3Treatment groups
Experimental Treatment
Active Control
Group I: Habitual Diet + 2 Servings of YogurtExperimental Treatment1 Intervention
Group II: Habitual Diet + 1.5 Servings of MilkExperimental Treatment1 Intervention
Group III: Habitual Diet (Control)Active Control1 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
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
University of SaskatchewanSaskatoon, Canada
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Who is running the clinical trial?
University of SaskatchewanLead Sponsor
Agriculture and Agri-Food CanadaCollaborator
Dairy Farmers of CanadaCollaborator
References
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]Milk products are good sources of calcium and their consumption may reduce bone resorption and thus contribute to prevent bone loss.
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]The current study compared the effects of milk, yogurt or whey on the bone strength, body composition and serum biomarkers. Forty 12-week-old female Sprague-Dawley rats were ovariectomized (OVX), and another nine rats received a sham operation (Sham-Cont). After a 1-week recovery period, the OVX rats were divided into four dietary groups: OVX-control group (OVX-Cont), 17% skimmed milk powder diet group (OVX-Milk), 17% powdered fermented milk diet group (OVX-Yogurt) and 12% whey powder and 6% whey protein extract diet group (OVX-Whey) (n=10 in each group). The protein, nitrogen, fat, calcium and phosphorus contents of the experimental diets were adjusted to be similar to the control diet (AIN-93M). Eighty-four days after the beginning of the experimental diet, the total bone mineral density and bone mineral contents of lumbar vertebrae were significantly higher in the OVX-Milk and OVX-Whey groups than in the OVX-Cont group. Furthermore, the level of 1alpha, 25-dihydroxyvitamin D3 [1alpha, 25(OH)2D3] was significantly lower, while the serum level of FGF23 was significantly higher in the OVX-Milk, OVX-Yogurt and OVX-Whey groups than in the OVX-Cont group. These findings suggest that milk and the dairy products could improve bone metabolism in a postmenopausal animal model at least partly through changing the balance between 1alpha, 25(OH)2D3 and FGF23.
Milk and yogurt consumption are linked with higher bone mineral density but not with hip fracture: the Framingham Offspring Study. [2021]Dairy foods are a complex source of essential nutrients. In this study, fluid dairy intake, specifically milk, and yogurt intakes were associated with hip but not spine bone mineral density (BMD), while cream may adversely influence BMD, suggesting that not all dairy products are equally beneficial for the skeleton.
[Scientific evidence about the role of yogurt and other fermented milks in the healthy diet for the Spanish population]. [2014]Milk products contain proteins of high biologic value and digestibility; they also contain fat, carbohydrates, vitamins and minerals, specially calcium and phosphorus. Diversification of milk products consumption allows a high consumptiom of the above mentioned products, optimizing nutrient intake. In Spain, food consumption of milk products lower than the recommended amounts was observed in 20 to 40 % of the children and 30 to 45 % of the adults. Milk products represent 44 to 70 % of calcium intake in the Spanish population. Milk products consumption is positively associated with a high bone mineral density. More than 35 % of children and adults in Spain had calcium intakes below the national recommendations. Yogur contains less lactose than regular milk and fermenting milk bacteries express functioning lactase. Yogur intake is recommended to improve lactose digestion in individuals having lactose maldigestion. It seems reasonable to recommend yogur to improve calcium absorption, at least in post-menopausal women, and also for decreasing incidence and duration of infectious gastrointestinal disorders in children. Fermented milk products consumption, before, during and after medical eradication of Helicobacter Pylori, increases 5 to 10 % the effect of the specific drug therapy. Its consumption before, during and after antibiotic treatment, could also reduce the risk of diarrhea associated with the use of the above mentioned drugs. The Spanish Federation of Nutrition, Feeding and Dietetic Societies (FESNAD) recommend the following consumption of milk and milk products: Adults, 2-3 portions/day; school-age children, 2-3 portions/day; adolescents, 3-4 portions/day; pregnant and lactating women and during menopause, 3-4 portions/day; elderly, 2-4 portions/day. Considering yogur and fermented milk consumption show some advantages when compared with other milk products, we can recommend yogur within a daily and varied consumption of milk products.
Protective association of milk intake on the risk of hip fracture: results from the Framingham Original Cohort. [2021]Dairy foods are rich in bone-beneficial nutrients, yet the role of dairy foods in hip fracture prevention remains controversial. Our objective was to evaluate the association of milk, yogurt, cheese, cream, and milk + yogurt intakes with incident hip fracture in the Framingham Original Cohort. A total of 830 men and women from the Framingham Original Cohort, a prospective cohort study, completed a food-frequency questionnaire (1988 to 1989) and were followed for hip fracture until 2008. In this population-based study, Cox-proportional hazards regression was used to estimate hazard ratios (HR) by categories of energy-adjusted dairy intake (servings/wk), adjusting for standard confounders and covariates. The exposure was energy-adjusted intakes of milk, yogurt, cheese, cream, and milk + yogurt (servings/wk). Risk of hip fracture over the follow-up was the primary outcome; the hypothesis being tested was formulated after data collection. The mean age at baseline was 77 years (SD 4.9, range 68 to 96). Ninety-seven hip fractures occurred over the mean follow-up time of 11.6 years (range 0.04 to 21.9 years). The mean ± SD (servings/wk) of dairy intakes at baseline were: milk = 6.0 ± 6.4; yogurt = 0.4 ± 1.3; cheese = 2.6 ± 3.1; and cream = 3.4 ± 5.5. Participants with medium (>1 and
A scoping review of the public health impact of vitamin D-fortified dairy products for fracture prevention. [2018]Dairy products are rich in nutrients that positively influence bone health and hence fracture risk, and have therefore been recommended and used for fracture prevention. To help decision makers to efficiently allocate scare resources, it is further important to assess the public health and economic impact of any health intervention. In recent years, several studies have been conducted to estimate the public health and/or economic impact of dairy products but no overview is currently available. This article aims therefore to summarize evidence and review articles that estimated the public health and/or economic impact of vitamin D-fortified dairy products for fracture prevention.
Effects of Fermented Milk Products on Bone. [2019]Fermented milk products like yogurt or soft cheese provide calcium, phosphorus, and protein. All these nutrients influence bone growth and bone loss. In addition, fermented milk products may contain prebiotics like inulin which may be added to yogurt, and provide probiotics which are capable of modifying intestinal calcium absorption and/or bone metabolism. On the other hand, yogurt consumption may ensure a more regular ingestion of milk products and higher compliance, because of various flavors and sweetness. Bone mass accrual, bone homeostasis, and attenuation of sex hormone deficiency-induced bone loss seem to benefit from calcium, protein, pre-, or probiotics ingestion, which may modify gut microbiota composition and metabolism. Fermented milk products might also represent a marker of lifestyle promoting healthy bone health.
Fermented Milk Products and Bone Health in Postmenopausal Women: A Systematic Review of Randomized Controlled Trials, Prospective Cohorts, and Case-Control Studies. [2023]Milk and milk product consumption is positively associated with bone mineral density (BMD). Emerging evidence suggests that fermented milk products (FMPs) may have specific beneficial effects on skeletal health. We conducted a systematic review and meta-analysis to assess the effect of FMPs on bone health indicators in postmenopausal women given their increased risk for osteoporosis and fragility fractures. Electronic databases were searched for randomized controlled trials (RCTs) and prospective cohort and case-control studies that examined the relation between FMPs and bone health outcomes (fracture incidence, BMD, BMD T-score, and percentage change in bone turnover markers) in postmenopausal women. Two reviewers independently conducted abstract and full-text screenings and data extractions. Risk of bias was assessed using the RoB 2.0 tool and the Newcastle-Ottawa scale for interventional and observational studies. Pooled RRs were obtained using a random-effects model by the DerSimonian-Laird method. Three RCTs, 3 prospective cohorts, and 3 case-control studies met the inclusion criteria. Results of the meta-analysis of 3 cohort studies (n = 102,819) suggest that higher yogurt consumption was associated with reduced hip fracture risk (pooled RR: 0.76; 95% CI: 0.63, 0.92, I2 = 29%), but no difference in hip fracture risk was found between higher and lower cheese consumption (pooled RR: 0.89; 95% CI: 0.73, 1.10, I2 = 0%). Case-control studies revealed that cheese intake had either a null or a protective effect against osteoporosis (BMD T-score ≤-2.5). Daily yogurt or cheese intervention (
The Effects of Milk Supplementation on Bone Health Indices in Adults: A Meta-Analysis of Randomized Controlled Trials. [2023]Milk contains a number of bone-beneficial nutrients. However, milk, due to the D-galactose content, might have unfavorable effects on bone health. A meta-analysis of randomized controlled trials (RCTs) was performed to clarify the effects of milk supplementation on bone mineral density (BMD), bone turnover markers [N-terminal telopeptide of type I collagen (NTx), C-terminal telopeptide of type 1 collagen (CTx), osteocalcin, bone alkaline phosphatase (BALP), and procollagen type 1 N-propeptide (P1NP)], and hormonal indices related to bone metabolism [parathyroid hormone (PTH), 25-hydroxyvitamin D [25(OH)D], and insulin-like growth factor 1 (IGF-1)] in adults. The PubMed and Web of Science databases were searched. A random-effects model was used to estimate the pooled effect sizes. A total of 20 RCTs were included. The trial duration ranged from 1 mo to 36 mo. Milk supplementation resulted in a small but significant increase in BMD at the hip (+0.004 g/cm2; n = 9 RCTs) and lumbar spine (+0.025 g/cm2; n = 7), but did not significantly affect whole-body BMD (n = 3) and femoral neck BMD (n = 7). Milk supplementation reduced the concentrations of P1NP (-5.20 ng/mL; n = 9), CTx (-0.16 ng/mL; n = 9), and NTx (-8.66 nmol bone collagen equivalents/mmol creatinine; n = 3). The concentrations of osteocalcin (n = 9) and BALP (n = 3) were not affected by milk supplementation. Reduced parathyroid hormone PTH (-1.01 pg/mL; n = 13) concentrations and increased IGF-1 (+1.79 nmol/l; n = 4) concentrations were observed with milk supplementation. 25(OH)D (+3.73 ng/mL; n = 11) concentrations were increased with vitamin-D fortified milk supplementation. The addition of milk to the diet may potentially increase the likelihood of preventing bone loss by restoring bone homeostasis through the modulation of the calcium-vitamin D-PTH axis, bone remodeling rate, and growth hormone/IGF-1 axis.
Milk intake and hip fracture incidence in community-dwelling old Icelandic adults. [2023]Milk and milk products have been known as important for bone health. Can ingestion of milk and milk products lower hip fracture risk for older adults? In this study, older Icelandic adults who were ingesting higher milk had a lower risk of hip fractures.