UC Davis Intermittent Fasting Study

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"Does fasting affect the interactions between the human microbiome, HDL, and the immune system to produce anti-inflammatory effects?"
Age:
20-40 years old
Gender:
Any
Healthy Volunteers:
Yes
Keywords:
fasting, high density lipoproteins (HDL), gut microbiota, immune function
Type:
Nutritional Intervention
Investigator:
Description
The purpose of this study is to investigate whether a period of roughly 36 hours of water-only fasting changes the composition and/or function of the gut microbiota and high density lipoproteins (HDL) and the impact of these changes on the immune system.

Previous studies of intermittent fasting have shown that fasting produces numerous beneficial health effects in humans including a reduction in systemic inflammation. However, the underlying mechanisms of how fasting induces these anti-inflammatory effects remains largely unknown. We hypothesize that fasting induces changes to the human microbiome and HDL composition and functionality that go on to affect the immune system to reduce inflammation and increase beneficial functions such as reverse cholesterol transport. Our experimental assessments will focus on how fasting has affected the microbiome and HDL's ability to interact with the immune system and how these interactions affect systemic inflammation and immune cell reactivity.

Participants in the study will undergo a 3-4 day trial including 2 days of consuming their normal habitual diet with 1 period of 36hrs of water-only fasting in between. There will be 4 blood draws (8am and 8pm, Day 1 and Day 3) at The Ragle Human Nutrition Center on the UC Davis campus and blood glucose readings and microbiome sample collections will also be taken throughout the 3 day study period. A conditional 4th day may be requested to procure an additional microbiome sample.
This study requires
  • Willing to undergo a period of 36 hours of water-only fasting

  • Willing and able to give 4 blood samples at approximately 8AM and 8PM on both Day 1 and Day 3 of the study

  • Willing to collect samples of each bowel movement produced throughout the study period for microbiome analysis

  • Willing to collect and test blood pricks for blood glucose levels using a Contour NextOne Glucose Testing Kit during the fasting stage of the study protocol

  • Willing to eat identical diets on Days 1 and 3 of the study

  • Complete basic health questionnaires and food records

Who can participate

Inclusion Criteria:

  • Age: 20-40 years old to constitute a young study population

  • BMI: 19-27 kg/m2 to constitute a normal/healthy weight population

  • Weight: 120lbs 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 NextOne Glucose Testing Kit during the fasting stage of the study protocol

  • Subjects must be willing to eat identical diets on on their two regular eating days

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 on average

  • 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

  • Use of any form of hormonal birth control including oral contraception pills, hormonal IUDs or rings, or hormonal birth control patches

  • Irregular or infrequent bowel movements (>4 or <1 bowel movement(s)/day)

Benefits and risks of participating
Possible benefits for you include learning how your clinical blood values, gut microbiota, and aspects of your HDL and immune function change in response to a period of 36 hours of water-only fasting. You will also receive detailed information about the nutritional breakdown of your food record. The study will benefit others by contributing to our scientific knowledge on the relationship between prolonged fasting and the human microbiome and HDL composition and function.

There is a chance of temporary discomfort, bruising, or very rarely, an infection at the site where blood was drawn. Precautions will be taken to minimize these risks including use of skilled phlebotomists and nurses, and aseptic/sterile techniques.

The primary potential risk to subjects during this study will be the physiological effects that may be induced during the fasting phase of the trial. While undergoing fasting you may experience mild sideeffects such as light-headedness, headache, nausea, lack of energy, or hunger. While unlikely, it is possible that there may be more severe side effects during the fasting phase such as fatigue, hypoglycemia, or fainting. You may also experience some temporary, reversible metabolic changes. An additional potential risk is the use of the Contour NextOne Glucose Testing Kit for monitoring of blood glucose levels during the fasting period. You will be asked to use a blood lancet device provided in the Contour NextOne kit to perform self-administered blood pricks to collect blood glucose data. There is a chance of a small amount of discomfort associated with the lancing process and a very small risk of infection at the site of the blood prick.

There are no known psychological, social or legal injury risks for participating in this study.

There may also be risks to your confidentiality. The research staff will store study records and other information about you in a secure location and will grant access only to those with a need to know.
Compensation
If you agree to take part in this research study, we will compensate you $100 for your time and effort. If you withdraw early, you will be provided pro-rated compensation: $50 for the completion of Study Visit 3 and the final $50 for the collection of your final microbiome sample at or beyond Visit 4.

Compensation will be in the form of gift cards.
Resources
Schedule
Study duration and period
3-4 days including 2 days of consuming your normal habitual diet with 1 period of 36hrs of water-only fasting in between. There will be 4 blood draws (8am and 8pm, Day 1 and Day 3) at The Ragle Human Nutrition Center on the UC Davis campus and blood glucose readings and microbiome sample collections will also be taken throughout the 3 day study period. A conditional 4th day may be requested to procure an additional microbiome sample.
Recruitment period
From Aug. 24, 2017
Location
Ragle Human Nutrition Research Center
1 Shields Avenue
1283 Academic Surge
Davis, CA 95616
Contact
Christopher Rhodes

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