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

NCT06265246 | Recruiting

• 1 other identifier: 104993
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Femoral neck bone mineral density

  Measurement will be done via Dual Energy X-ray Absorptiometry.

  Baseline, month 12, month 24

Secondary Outcomes (2)

• Bone mineral density (total hip, lumbar spine, whole body)

  Baseline, month 12, month 24

• Bone mineral content (total hip, femoral neck, lumbar spine, whole body)

  Baseline, month 12, month 24

Other Outcomes (17)

• Bone structure

  Baseline, month 12, month 24

• Bone geometry

  Baseline, month 12, month 24

• Serum bone alkaline phosphatase (biochemical indices of bone turnover)

  Baseline, month 12, month 24

Study Arms (3)

Habitual Diet (Control)

NO INTERVENTION

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

Habitual Diet + 1.5 Servings of Milk

EXPERIMENTAL

Other: Habitual Diet + Milk

Habitual Diet + 2 Servings of Yogurt

EXPERIMENTAL

Other: Habitual Diet + Yogurt

Interventions

Habitual Diet + Milk OTHER

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

Habitual Diet + 1.5 Servings of Milk

Habitual Diet + Yogurt OTHER

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)

Habitual Diet + 2 Servings of Yogurt

Eligibility Criteria

• Age: 19 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Saskatchewan: lead
• Dairy Farmers of Canada: collaborator
• Agriculture and Agri-Food Canada: collaborator

Study Sites (1)

University of Saskatchewan

Saskatoon, Saskatchewan, S7N 5E5, Canada

RECRUITING

MeSH Terms

Conditions

Osteoporosis; Obesity

Interventions

Milk; Yogurt

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Dairy Products; Food; Food and Beverages; Cultured Milk Products; Fermented Foods

Study Officials

• Hassan Vatanparast, MD, PhD

  University of Saskatchewan

  PRINCIPAL INVESTIGATOR

• Phil Chilibeck, PhD

  University of Saskatchewan

  PRINCIPAL INVESTIGATOR

• Sandra Clarke

  Agriculture and Agri-Food Canada

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hassan Vatanparast, MD, PhD

CONTACT

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

Zoe Longworth, MPH

CONTACT

zoe.longworth@usask.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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)

Study Record Dates

• First Submitted: February 1, 2024
• First Posted: February 20, 2024
• Study Start: September 1, 2024
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 15, 2028
• Last Updated: August 16, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)