University of Saskatchewan
Saskatoon, Saskatchewan, S7N 5E5, Canada
Location status: Recruiting
Location contact
Hassan Vatanparast
CONTACT
NCT Number: NCT06265246
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.
Interested in participating?
Request Info19 year–30 year
All sexes
Interventional
Not applicable
Saskatoon, Saskatchewan, S7N 5E5, Canada
Location status: Recruiting
Hassan Vatanparast
CONTACT
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:
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
1.5 servings of milk [providing approx. 500 mg Ca/day] per day (either 1% fat milk, or 2% fat milk)
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)
Time frame: Baseline, month 12, month 24
Measurement will be done via Dual Energy X-ray Absorptiometry.
Time frame: Baseline, month 12, month 24
Measurement will be done via Dual Energy X-ray Absorptiometry.
Time frame: Baseline, month 12, month 24
Measurement will be done via Dual Energy X-ray Absorptiometry.
Time frame: Baseline, month 12, month 24
Measurement via HR-pQCT scan at distal radius and tibia
Time frame: Baseline, month 12, month 24
Measurement via HR-pQCT scan at distal radius and tibia
Time frame: Baseline, month 12, month 24
Fasting 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.
Time frame: Baseline, month 12, month 24
Fasting 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.
Time frame: Baseline, month 12, month 24
Fasting 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.
Time frame: Baseline, month 12, month 24
Fasting 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.
Time frame: Baseline, month 12, month 24
Fasting 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.
Time frame: Baseline, month 12, month 24
Fasting 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.
Time frame: Baseline, month 12, month 24
Fasting 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.
Time frame: Baseline, month 12, month 24
Fasting 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.
Time frame: Baseline, month 12, month 24
Saliva samples will be collected from each participant for analysis of salivary IGF-1 and comparison to serum IGF-1.
Time frame: Baseline, month 12, month 24
Measurement via Dual Energy X-ray Absorptiometry.
Time frame: Baseline, month 12, month 24
Height (cm) in standing position will be measured to the nearest 0.1 cm by a wall-mounted stadiometer.
Time frame: Baseline, month 12, month 24
For 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.
Time frame: Baseline, month 12, month 24
Stool 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
Time frame: Baseline, month 6, month 12, month 18, month 24
Dietary 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.
Time frame: Baseline, month 6, month 12, month 18, month 24
Physical 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.
Contact information is provided by the study sponsor or research team.
Hassan Vatanparast, MD, PhD
CONTACT
Zoe Longworth, MPH
CONTACT
University of Saskatchewan
Other
The Effects of Milk and Yogurt Supplementation on Bone Health, Body Composition, and Gut Microbiota in Canadian Young Adults: A Randomized Controlled Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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