Recruiting

Milk & Yogurt

Sponsor:

University of Saskatchewan

Code:

NCT06265246

Conditions

Osteoporosis

Obesity

Eligibility Criteria

Sex: All

Age: 19 - 30

Healthy Volunteers: Accepted

Interventions

Habitual Diet + Milk

Habitual Diet + Yogurt

Study Details

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.

Conditions

Osteoporosis

Obesity

Study ID

NCT06265246

Start date

Sep 1, 2024

Status verified date

Aug, 2024

Completion date

May 15, 2028

Anticipated

Primary completion date

May 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19 - 30

Healthy Volunteers: Accepted

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

Study Design

Enrollment

99 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

no intervention: Habitual Diet (Control)

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

experimental: Habitual Diet + 1.5 Servings of Milk

experimental: Habitual Diet + 2 Servings of Yogurt

Interventions

Habitual Diet + Milk

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

Habitual 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)

Primary outcome measure

  • Femoral neck bone mineral density [ Time Frame: Baseline, month 12, month 24 ]

Central Contacts and Locations

Central contacts

Hassan Vatanparast, MD, PhD

306-966-8866vatan.h@usask.ca

Zoe Longworth, MPH

zoe.longworth@usask.ca

Locations

University of Saskatchewan

Recruiting

Saskatoon, Saskatchewan, Canada, S7N 5E5

More Information

Sponsor

University of Saskatchewan

Last update posted

Aug 16, 2024

Last verified

Aug, 2024

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Saskatchewan on 2024-08-16.