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

The Effects of Milk and Yogurt Supplementation on Bone Health, Body Composition, and Gut Microbiota in Canadian Young Adults: A Randomized Controlled Trial

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06265246
Enrollment
99
Registered
2024-02-20
Start date
2024-09-01
Completion date
2028-05-15
Last updated
2024-08-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Osteoporosis

Keywords

probiotics, cultured milk products, milk, osteoporosis, obesity, gastrointestinal microbiome, body composition, yogurt

Brief 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. 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: 1. 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. 2. 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. 3. 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. 4. 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. 5. To examine the effects of milk and fermented milk product supplementation on gut microbiota of Canadian adults aged 19 to 30

Interventions

OTHERHabitual Diet + Milk

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

OTHERHabitual Diet + Yogurt

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)

Sponsors

Dairy Farmers of Canada
CollaboratorOTHER
Agriculture and Agri-Food Canada
CollaboratorOTHER_GOV
University of Saskatchewan
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention 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)

Eligibility

Sex/Gender
ALL
Age
19 Years to 30 Years
Healthy volunteers
Yes

Inclusion criteria

* 19-30 years old * Dietary calcium intake below 1000mg/ day * living in the Saskatoon area (Saskatchewan, Canada)

Exclusion criteria

* 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 * 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

Design outcomes

Primary

MeasureTime frameDescription
Femoral neck bone mineral densityBaseline, month 12, month 24Measurement will be done via Dual Energy X-ray Absorptiometry.

Secondary

MeasureTime frameDescription
Bone mineral density (total hip, lumbar spine, whole body)Baseline, month 12, month 24Measurement will be done via Dual Energy X-ray Absorptiometry.
Bone mineral content (total hip, femoral neck, lumbar spine, whole body)Baseline, month 12, month 24Measurement will be done via Dual Energy X-ray Absorptiometry.

Other

MeasureTime frameDescription
Serum osteocalcin (biochemical indices of bone turnover)Baseline, month 12, month 24Fasting 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.
Serum procollagen type 1 N-propeptide (biochemical indices of bone turnover)Baseline, month 12, month 24Fasting 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 ananalysis of all serum measures.
Serum N-terminal telopeptide of type 1 collagen (biochemical indices of bone turnover)Baseline, month 12, month 24Fasting 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.
Serum C-terminal telopeptide of type 1 collagen (biochemical indices of bone turnover)Baseline, month 12, month 24Fasting 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 aanalysis of all serum measures.
Serum PTH (hormonal indices related to bone metabolism)Baseline, month 12, month 24Fasting blood samples 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 for the analysis of all serum measures.
Serum 25(OH)D (hormonal indices related to bone metabolism)Baseline, month 12, month 24Fasting blood samples 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 for the analysis of all serum measures.
Serum IGF-1 (hormonal indices related to bone metabolism)Baseline, month 12, month 24Fasting blood samples 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 for the analysis of all serum measures.
Bone structureBaseline, month 12, month 24Measurement via HR-pQCT scan at distal radius and tibia
Fat mass and lean massBaseline, month 12, month 24Measurement via Dual Energy X-ray Absorptiometry.
HeightBaseline, month 12, month 24Height (cm) in standing position will be measured to the nearest 0.1 cm by a wall-mounted stadiometer.
WeightBaseline, month 12, month 24For weight measurements, participants will be asked to wear light clothes and remove their shoes and jewelry and then stand on the SECA electronic scale to measure the weight to the nearest 0.01 kg.
Gut microbiota via general lactobacillus and bifdobacteriumBaseline, month 12, month 24Stool samples will be collected using DNAgenotek Omnigene sample collection kits and the total DNA of gut microbiomes from fecal material will be extracted using QIAamp PowerFecal Pro DNA Kit (Cat No. 51804), following manufacturer's instructions
Dietary assessmentBaseline, month 6, month 12, month 18, month 24Dietary intake will be assessed using serial 24-hour dietary recalls. Dietary data will be collected in person at baseline, 12 months, and 24 months and via telephone at 6 months and 18 months. The mean of three 24-h recalls at each time point will provide an estimation of the usual intake.
Physical activityBaseline, month 6, month 12, month 18, month 24Physical activity will be captured using the Physical Activity Adult Questionnaire (PAAQ) to include transportation, recreational, and occupational or household physical activity in the last 7 days.
Saliva IGF-1 (hormonal indices related to bone metabolism)Baseline, month 12, month 24Saliva samples will be collected from each participant for analysis of salivary IGF-1 and comparison to serum IGF-1.
Bone geometryBaseline, month 12, month 24Measurement via HR-pQCT scan at distal radius and tibia
Serum bone alkaline phosphatase (biochemical indices of bone turnover)Baseline, month 12, month 24Fasting 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.

Countries

Canada

Contacts

Primary ContactHassan Vatanparast, MD, PhD
vatan.h@usask.ca306-966-8866
Backup ContactZoe Longworth, MPH
zoe.longworth@usask.ca

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 14, 2026