Gut Microbiome Clinical Trial
Official title:
Effect of Yogurt on Mucosal Immunity in the Gastrointestinal Tract
Verified date | May 2024 |
Source | USDA, Western Human Nutrition Research Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this research is to assess mucosal immune function responses in the gastrointestinal (GI) tract to twice-daily yogurt consumption. Previous research has shown that dairy yogurt intake can benefit gastrointestinal health. The current study will determine whether a dietary intervention with dairy yogurt will improve mucosal immunity and the gut microbiome.
Status | Active, not recruiting |
Enrollment | 32 |
Est. completion date | June 30, 2024 |
Est. primary completion date | June 30, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 50 Years to 75 Years |
Eligibility | Inclusion Criteria: - Age 50 - 75 years - BMI 18.5 - 39.9 kg/m2 Exclusion Criteria: - BMI less than 18.5 or greater than 39.9 - Consumption of fermented foods or probiotics in the past two weeks - Unwillingness to abstain from non-study fermented foods and probiotics during the trial - Allergy to cow milk - Lactose intolerance - Any dietary restriction limiting or prohibiting consumption of lightly sweetened, vanilla flavored, whole milk yogurt - Uncomfortable with or unwilling to complete stool sample collections - Current participation in another research study - If female, - Currently pregnant or lactating - Have had menstrual bleeding in the past 12 months - Having fewer than 3 bowel movements per week - Unmanaged hypertension, defined as blood pressure greater than or equal to 140/90 mmHg - Current diagnosis of: - Disease that affects the immune system, including HIV/AIDS - Cancer - Diabetes - Asthma with daily medication - Primary immune deficiency - Auto-immune disease - Chronic gastrointestinal disorder (e.g. Crohn's disease, irritable bowel syndrome, colitis, gastric ulcer) - Current use for 2 weeks or longer of: - Any drug that affects the immune system, such as immunosuppressants, immune modifying drugs, or corticosteroids (e.g. cortisone, prednisone, methylprednisolone) - Biologics (e.g. Lantus, Remicade, Rituxan, Humira, Herceptin, Avastin, Lucentis, Enbrel) - Use of sulfonamides or antibiotics in the past 3 months - Use of laxatives in the past 2 weeks - Currently undergoing cancer treatment with radiation or drugs - History of gastrointestinal surgery that would impact study outcomes, such as gastric bypass, intestinal resection, surgeries of the liver or pancreas, or removal of part or all of any organ of the GI tract - Having within the past 2 weeks: - Diarrheal illness, defined as passing 3 or more abnormally loose or watery stools in a 24-hour period - Persistent vomiting - Fever - Having within the past 3 months: - Surgery - Hospitalization - Having within the past 1 month: - Colonoscopy |
Country | Name | City | State |
---|---|---|---|
United States | USDA Western Human Nutrition Research Center | Davis | California |
Lead Sponsor | Collaborator |
---|---|
USDA, Western Human Nutrition Research Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in fecal secretory immunoglobulin A | Fecal secretory immunoglobulin A (sIgA) will be extracted then measured in duplicate by enzyme-linked immunosorbent assay (ELISA) | At end of 2-week baseline period; at 1, 2 and 3 weeks of intervention; and at end of 2-week follow-up period | |
Secondary | Changes in fecal mucin-2 mRNA expression | Pre-amplification and quantitative reverse transcription polymerase chair reaction (RT-qPCR) for mucin 2 (MUC2) and GAPDH will be conducted using validated TaqMan assays, and fold MUC2 gene expression of samples will be calculated relative to a commercial total human colon RNA standard using GAPDH as the housekeeping gene. | At end of 2-week baseline period; at 1, 2 and 3 weeks of intervention; and at end of 2-week follow-up period | |
Secondary | Changes in fecal pH | Fecal pH will be measured with a glass electrode pH meter. | At end of 2-week baseline period; at 1, 2 and 3 weeks of intervention; and at end of 2-week follow-up period | |
Secondary | Changes in fecal short-chain fatty acids | The most abundant fecal SCFAs, such as acetate, propionate, butyrate, will be analyzed via gas chromatography-mass spectrometry. | At end of 2-week baseline period; at 1, 2 and 3 weeks of intervention; and at end of 2-week follow-up period | |
Secondary | Fecal microbiome | Gut microbiota composition will be assessed with PCR amplification and 16S sequencing | At end of 2-week baseline period; at 1, 2 and 3 weeks of intervention; and at end of 2-week follow-up period |
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