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Yogurt Intervention for Gut Health

N/A
Recruiting
Led By Danielle G Lemay, PhD
Research Sponsored by USDA, Western Human Nutrition Research Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at end of 2-week baseline period; at 1, 2 and 3 weeks of intervention; and at end of 2-week follow-up period
Awards & highlights

Study Summary

This trial will study how daily yogurt consumption affects gut health by testing mucosal immunity and gut microbiome.

Who is the study for?
This trial is for adults aged 50-75 with a BMI of 18.5-39.9, not currently on immune-affecting drugs or undergoing cancer treatment. Participants should not have had recent GI surgeries, be pregnant, lactating, or have unmanaged health conditions like hypertension.Check my eligibility
What is being tested?
The study tests if eating yogurt twice daily improves gut health and the immune system in the GI tract by looking at changes in mucosal immunity and gut microbiome composition.See study design
What are the potential side effects?
Potential side effects are not detailed but may include typical dairy consumption reactions such as digestive discomfort especially for those who might be sensitive to milk products.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at end of 2-week baseline period; at 1, 2 and 3 weeks of intervention; and at end of 2-week follow-up period
This trial's timeline: 3 weeks for screening, Varies for treatment, and at end of 2-week baseline period; at 1, 2 and 3 weeks of intervention; and at end of 2-week follow-up period for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Changes in fecal secretory immunoglobulin A
Secondary outcome measures
Changes in fecal mucin-2 mRNA expression
Changes in fecal pH
Changes in fecal short-chain fatty acids
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Yogurt ConsumptionExperimental Treatment1 Intervention
Participants will complete a 2-week baseline with no yogurt intake, followed by a three-week yogurt intervention, and then a 2-week follow-up period with no yogurt intake.

Find a Location

Who is running the clinical trial?

USDA, Western Human Nutrition Research CenterLead Sponsor
62 Previous Clinical Trials
21,075 Total Patients Enrolled
Danielle G Lemay, PhDPrincipal InvestigatorUSDA, Western Human Nutrition Research Center
Bess L Caswell, PhDPrincipal InvestigatorUSDA, Western Human Nutrition Research Center

Media Library

Gut Microbiome Clinical Trial 2023: Yogurt Intervention Highlights & Side Effects. Trial Name: NCT05931471 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this investigation accept volunteers aged 18 or older?

"This trial is only open to adults aged 50 to 75. However, there are a total of 14 studies available for those younger than 18 and 12 trials accessible to the elderly population over 65 years old."

Answered by AI

Is enrollment available for this investigation right now?

"As reported on clinicaltrials.gov, recruitment for this medical trial has since been suspended; it was initially posted on July 10th 2023 and the last update occurred June 26th 2023. However, there are presently 15 other trials that are currently accepting patients in need of treatment."

Answered by AI

Is it possible for me to participate in this scientific experiment?

"This research program is in search of 32 volunteers aged between 50 and 75, with a verifiable gut microbiome. To be considered for participation in this trial, these criteria must both be met."

Answered by AI
~7 spots leftby Jun 2024