Fasting Clinical Trial
Official title:
The Effects of Prolonged Fasting on the Microbiome and HDL Particles of Human Subjects
NCT number | NCT03487679 |
Other study ID # | 918915 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 9, 2018 |
Est. completion date | May 30, 2018 |
Verified date | September 2018 |
Source | University of California, Davis |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Participants will undergo one day of habitual eating followed by 36 hours of water only fasting and final day of habitual eating of the exact same diet consumed on the first eating day. Blood draws will be performed on Day 1 in a 10-12 hr fasted state and 2 hour postprandial state and again on Day 3 in a 36hr fasted state and a 2 hour post prandial state. Microbiome samples and blood glucose data will be collected throughout the course of the study.
Status | Completed |
Enrollment | 21 |
Est. completion date | May 30, 2018 |
Est. primary completion date | May 30, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 20 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Age: 20-40 years old to constitute a young study population; 60-80 years old to constitute an elderly study population - BMI: 19-27 kg/m2 to constitute a normal/healthy weight population - Weight: 133lbs or more - Fasting Glucose: 70-100mg/dL to ensure that fasting can be tolerated without inducing dangerously low levels of blood glucose - Subjects must be willing to undergo a period of 36 hours of water-only fasting - Subjects must be willing to collect samples of each bowel movement produced throughout the entire study period for microbiome analysis. - Subjects must be willing to collect and test blood pricks for blood glucose levels using a Contour Next ONE Blood Glucose Kit during the fasting stage of the study protocol. - Subjects must be willing to continuously wear a GoBe activity monitor throughout the course of the trial. Exclusion Criteria: - Smoker - Anemia - Pregnancy or current breast-feeding - Documented chronic diseases including diabetes, thyroid disease, metabolic syndrome, cancer, or previous cardiovascular events - Any inflammatory bowel disease including IBS, Crohn's Disease, Celiac Disease - Consumption of >1 alcoholic drink/day - Current consumption of any probiotic or prebiotic supplements - Extreme dietary or exercise patterns - Recent weight fluctuations (greater than 10% in the last six months) - Regular use of over-the-counter allergy or pain medications (>1/week) - Taking prescription lipid medications (e.g. statins) or other supplements known to alter lipoprotein metabolism such as isoflavones. |
Country | Name | City | State |
---|---|---|---|
United States | University of California Davis | Davis | California |
Lead Sponsor | Collaborator |
---|---|
University of California, Davis |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in HDL Immunomodulatory Capacity | HDL will be isolated from plasma samples and HDL immunomodulatory capacity will be assessed in isolated HDL with an in vitro assay using stimulated macrophages. | Baseline fasted vs. Post 36 hours fasted | |
Secondary | Change in Gut Microbiome Composition | Gut microbial composition will be assessed by sequencing of isolated DNA from stool samples. | Baseline fasted vs. Post 36 hours fasted |
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