What is the mechanism of action of this treatment?

Common treatments for inflammation include dietary interventions such as the intake of dairy products rich in calcium and protein. Calcium supports bone health by aiding in bone turnover and bone cell activity, while protein provides essential amino acids that help repair tissues and modulate inflammatory responses. These nutrients can reduce the post-exercise inflammatory response, which is particularly beneficial for inflammation patients as it helps in managing symptoms and improving overall health. By incorporating these nutrients, patients may experience reduced inflammation and better bone health, contributing to a higher quality of life.

What side effects are associated with this type of intervention?

Common treatments for inflammation that include dairy products rich in calcium and protein, as well as calcium and vitamin D supplementation, generally have a good safety profile. However, potential side effects can include gastrointestinal discomfort, such as bloating and constipation, particularly with high calcium intake. Excessive calcium supplementation has also been associated with an increased risk of kidney stones and, in some studies, a potential link to cardiovascular events, although evidence is mixed. Vitamin D supplementation is usually well-tolerated, but high doses can lead to hypercalcemia, which may cause nausea, vomiting, weakness, and serious complications like kidney damage.

What prior FDA approvals exist?

The FDA has approved various treatments for inflammation, including nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen and naproxen, corticosteroids such as prednisone, and biologics like TNF-alpha inhibitors (e.g., adalimumab and infliximab). While these are direct anti-inflammatory agents, nutritional approaches like calcium and vitamin D supplementation have also been recognized for their role in supporting bone health and potentially modulating inflammation. These nutrients, often found in dairy products, are essential for maintaining bone density and may help reduce inflammatory responses in the body.

What other types of research exist?

Promising alternatives to dairy products for inflammation patients include plant-based sources such as leafy green vegetables (e.g., kale, broccoli), nuts (e.g., almonds), seeds (e.g., chia, flaxseeds), and legumes (e.g., beans, lentils). Additionally, fish rich in omega-3 fatty acids (e.g., salmon, mackerel) and fortified plant-based milks (e.g., almond milk, soy milk) can provide necessary nutrients like calcium and protein. Supplements such as calcium and vitamin D can also be considered to support bone health and modulate inflammation.

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Behavioral Intervention

Dairy vs Carbs vs Water for Bone Health and Inflammation (BIONEX Trial)

N/A

Recruiting

Led By Andrea R Josse, PhD

Research Sponsored by York University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Between the ages of 18-30 years

On no medication related to a chronic condition

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 hours post-exercise

Awards & highlights

Summary

This trial tests if drinking milk, Greek yogurt, a sugary drink, or water after exercise can improve bone health and reduce inflammation in healthy young adults. The study will measure changes in indicators related to bones and inflammation. The goal is to find out if these simple dietary changes can help keep bones strong and reduce body swelling. Milk has been shown in various studies to promote bone formation and prevent bone loss.

Who is the study for?

This trial is for healthy young adults aged 18-30 with a normal BMI who are low to moderately active. Participants must either be on birth control or have regular menstrual cycles, and not be taking medication for chronic conditions. They should not have allergies to dairy protein, lactose intolerance, or smoke regularly.

What is being tested?

The study is examining if consuming dairy products like Greek yogurt and skim milk can influence bone health and reduce inflammation after high-intensity exercise compared to just having a carbohydrate drink (maltodextrin powder in water) or plain water.

What are the potential side effects?

Potential side effects may include digestive discomfort due to dairy consumption, especially in individuals who might discover they are sensitive to lactose despite no known intolerance. High-intensity exercise may also cause muscle soreness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 30 years old.

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I am not on any medication for a chronic condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 hours post-exercise

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 hours post-exercise

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 hours post-exercise for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Acute Bone Turnover/Cell Activity

Systemic Inflammation - Serum/Plasma Cytokines

Systemic inflammation - Immune Cells

Secondary study objectives

Muscle soreness

Performance - Jump Height

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Exercise and Milk (Milk)Experimental Treatment2 Interventions

Participants will have a fasted baseline blood sample taken upon arrival to the lab. Then they will take part in a high-intensity exercise protocol, consisting of high-intensity interval cycling, resistance exercise, and plyometrics. Following exercise, participants will return to the lab for a 5min post-exercise blood sample, and then consume \~500ml plain skim milk (0% milk fat). An additional blood sample will be taken at 1h post-exercise, followed by an additional \~500ml of skim milk. Blood samples will also be taken at 4h and 24h post-exercise. Participants will also rate their muscle soreness and perform a jump height test at pre-exercise, 5min post-exercise, 4h and 24h post-exercise.

Group II: Exercise and Greek Yogurt (GY)Experimental Treatment2 Interventions

Participants will have a fasted baseline blood sample taken upon arrival to the lab. Then they will take part in a high-intensity exercise protocol, consisting of high-intensity interval cycling, resistance exercise, and plyometrics. Following exercise, participants will return to the lab for a 5min post-exercise blood sample, and then consume \~200g Greek yogurt (0% milk fat). An additional blood sample will be taken at 1h post-exercise, followed by an additional \~200g of Greek yogurt. Blood samples will also be taken at 4h and 24h post-exercise. Participants will also rate their muscle soreness and perform a jump height test at pre-exercise, 5min post-exercise, 4h and 24h post-exercise.

Group III: Exercise and Carbohydrate (CHO)Active Control2 Interventions

Participants will have a fasted baseline blood sample taken upon arrival to the lab. Then they will take part in a high-intensity exercise protocol, consisting of high-intensity interval cycling, resistance exercise, and plyometrics. Following exercise, participants will return to the lab for a 5min post-exercise blood sample, and then consume \~50g of maltodextrin mixed with water (\~500ml). An additional blood sample will be taken at 1h post-exercise, followed by an additional \~500ml of the maltodextrin drink. Blood samples will also be taken at 4h and 24h post-exercise. Participants will also rate their muscle soreness and perform a jump height test at pre-exercise, 5min post-exercise, 4h and 24h post-exercise.

Group IV: Exercise and Water (W)Placebo Group2 Interventions

Participants will have a fasted baseline blood sample taken upon arrival to the lab. Then they will take part in a high-intensity exercise protocol, consisting of high-intensity interval cycling, resistance exercise, and plyometrics. Following exercise, participants will return to the lab for a 5min post-exercise blood sample, and then consume \~500ml water. An additional blood sample will be taken at 1h post-exercise, followed by an additional \~500ml water. Blood samples will also be taken at 4h and 24h post-exercise. Participants will also rate their muscle soreness and perform a jump height test at pre-exercise, 5min post-exercise, 4h and 24h post-exercise.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Greek yogurt

2011

N/A

~60

Skim Milk

2018

N/A

~80

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for inflammation include dietary interventions such as the intake of dairy products rich in calcium and protein. Calcium supports bone health by aiding in bone turnover and bone cell activity, while protein provides essential amino acids that help repair tissues and modulate inflammatory responses. These nutrients can reduce the post-exercise inflammatory response, which is particularly beneficial for inflammation patients as it helps in managing symptoms and improving overall health. By incorporating these nutrients, patients may experience reduced inflammation and better bone health, contributing to a higher quality of life.

Find a Location

Who is running the clinical trial?

York UniversityLead Sponsor

63 Previous Clinical Trials

521,366 Total Patients Enrolled

Andrea R Josse, PhDPrincipal InvestigatorYork University

1 Previous Clinical Trials

13 Total Patients Enrolled

~6 spots leftby Dec 2024

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