Effects of Prolonged Fasting on Microbiome and HDL
The Effects of Prolonged Fasting on the Microbiome and HDL Particles of Human Subjects
1 other identifier
interventional
21
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 1, 2018
CompletedFirst Posted
Study publicly available on registry
April 4, 2018
CompletedStudy Start
First participant enrolled
April 9, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2018
CompletedSeptember 27, 2018
September 1, 2018
2 months
March 1, 2018
September 25, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Change in Gut Microbiome Composition
Baseline fasted vs. Post 36 hours fasted
Study Arms (1)
Fasting
EXPERIMENTALParticipants 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.
Interventions
Participants will undergo one day of habitual eating followed by 36 hours of water-only fasting and final day of habitual eating consuming 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.
Eligibility Criteria
You may qualify if:
- \- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of California Davis
Davis, California, 95616, United States
Related Publications (1)
Rhodes CH, Zhu C, Agus J, Tang X, Li Q, Engebrecht J, Zivkovic AM. Human fasting modulates macrophage function and upregulates multiple bioactive metabolites that extend lifespan in Caenorhabditis elegans: a pilot clinical study. Am J Clin Nutr. 2023 Feb;117(2):286-297. doi: 10.1016/j.ajcnut.2022.10.015. Epub 2022 Dec 20.
PMID: 36811567DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Angela M Zivkovic, Ph.D.
UC Davis
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 1, 2018
First Posted
April 4, 2018
Study Start
April 9, 2018
Primary Completion
May 30, 2018
Study Completion
May 30, 2018
Last Updated
September 27, 2018
Record last verified: 2018-09