The effects of fasting on HDL or good cholesterol, and the gut microbiome

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"Does 36 hours of water-only fasting change the composition and/or function of the gut microbiota and good cholesterol (HDL)?"
Age:
20-40 and 60-80 years old
Gender:
Any
Healthy Volunteers:
Yes
Keywords:
fasting, high density lipoproteins (HDL), gut microbiota
Type:
Other
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) or good cholesterol.
This study requires
• Willing to undergo a period of 36 hours of water-only fasting
• 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 ketone levels using a Precision Xtra Blood Ketone Testing
• Kit during the fasting stage of the study protocol
• Willing to continuously wear a GoBe activity monitor throughout the course of the trial
• Complete basic health questionnaires and food records
Who can participate?
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 ketone levels using a Precision Xtra Blood Ketone Testing 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
Benefits and risks of participating
Possible benefits for you include learning how your clinical blood values and gut microbiota 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 Precision Xtra Blood Ketone Testing Kit for monitoring of blood ketone levels during the fasting period. You will be asked to use a blood lancet device provided inthe Precision Xtra kit to perform self-administered blood pricks to collect blood ketone 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: $10 for completion of Visit 1 and 2, an additional $40 for completion of Visit 3 and then the final $50 for completion of Visit 4.

Compensation will be in the form of gift cards.
Resources
Schedule
Study duration and period
Six days: This includes the study procedures which last for 3 days, and the 3 days beforehand during which you will complete a 3-day food record and food frequency questionnaire
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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