Back to resultsPhysiological and Sensory Responses to Prolonged Fasting in Humans (PRO-FAST)
Primary Purpose
Fasting, Metabolic Disturbance, Energy Supply; Deficiency
Status
Active
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Prolonged Fasting
Sponsored by
About this trial
This is an interventional basic science trial for Fasting
Eligibility Criteria
Inclusion Criteria: • Body mass index 20.0-29.9 kg∙m-2 Age 18-45 years Willing to abstain from food intake for just over 3 days (~82 hours) Able and willing to provide informed consent and safely comply with study procedures Females to maintain record of regular menstrual cycle phase or contraceptive use No anticipated changes in lifestyle during the study (e.g. holidays or exercise programmes) Exclusion Criteria: • Any reported condition or behaviour deemed either to pose undue personal risk to the participant or introduce bias Any diagnosed metabolic disease (e.g. type 1 or type 2 diabetes) Any reported use of substances which may pose undue personal risk to the participants or introduce bias into the experiment Pregnancy Breastfeeding Lifestyle not conforming to standard sleep-wake cycle (e.g. shift worker) History of eating disorders (e.g. anorexia) Any reported recent (<6 months) change in body mass (± 3%) Uncontrolled hyperthyroidism Advanced cerebrovascular insufficiency or dementia Advanced liver or kidney insufficiency History of migraine and or headache Psychotic disorders Unstable or severe coronary artery disease Retinal detachment Duodenal or stomach ulcer Cancer and malignant disease Regular use of Non-steroidal anti-inflammatory drugs (NSAIDs) Use of Systemic corticoids Use of Antihypertensives (especially beta-blockers and diuretics) Use of Antidiabetics Use of Anti-coagulants Use of Psychotropics (especially neuroleptics and lithium) Use of Anticonvulsants.
Sites / Locations
- University of Bath
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Prolonged Fasting
Arm Description
All participants are asked to act as their own control prior to being asked to undergo 3 days of fasting.
Outcomes
Primary Outcome Measures
Change in postprandial insulin responses
Change in postprandial insulin (mmol/L) response to a standardised meal before and after 3 days of fasting.
Secondary Outcome Measures
Change in circulating glycerol and non-esterified fatty acids
Change in indices of lipolysis from adipose tissue in response to prolonged fasting (Glycerol mmol/L; NEFA mmol/L)
Change in Autophagy
Change in autophagic flux in response to prolonged fasting, assessed in skeletal muscle and circulating neutrophils.
Change in plasma lactate
Change in plasma lactate in response to prolonged fasting (indices of Cori cycle)
Change in plasma pyruvate
Change in plasma pyruvate in response to prolonged fasting (indices of Cori cycle)
Change in ketosis.
Change in urinary (acetoacetate) ketones in response to prolonged fasting.
Change in ketosis.
Change in circulating (beta-hydroxybutyrate) ketones in response to prolonged fasting.
Change in body mass
Change in body mass, pre-post, and during the prolonged fast.
Change in blood pressure
Change in blood pressure pre-, post-, and during the prolonged fast
Change in interstitial fluid glucose concentrations
Change in interstitial fluid glucose concentrations pre-, post-, and during the prolonged fast (assessed via continual glucose monitoring)
Change in amino acid metabolism
Change in amino acid metabolism (i.e. BCAAs and ketoacids) in skeletal muscle
Change in amino acid metabolism
Change in amino acid metabolism (i.e. BCAAs and ketoacids) in adipose tissue
Change in amino acid metabolism
Change in amino acid metabolism (i.e. BCAAs and ketoacids) in circulation
Change in postprandial glucose responses.
Change in postprandial glucose (mmol/L) response to a standardised meal before and after 3 days of fasting.
Full Information
NCT ID
NCT05977569
First Posted
September 7, 2021
Last Updated
July 26, 2023
Sponsor
University of Bath
Collaborators
University of Nottingham
1. Study Identification
Unique Protocol Identification Number
NCT05977569
Brief Title
Physiological and Sensory Responses to Prolonged Fasting in Humans
Acronym
PRO-FAST
Official Title
Physiological and Sensory Responses to Prolonged Fasting in Humans
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 28, 2021 (Actual)
Primary Completion Date
May 30, 2024 (Anticipated)
Study Completion Date
May 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Bath
Collaborators
University of Nottingham
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study aims to establish the metabolic/molecular response in both adipose tissue and skeletal muscle as well as sensory experiences (pain, fatigue, drive) to prolonged fasting of 3 days duration. Participants will undergo sequential meal assessment before and after a 3 day fast with measures taken throughout each fasting day.
Detailed Description
This study will employ a single-arm, non-randomised design in which participants will act as their own control prior to undergoing 3 days of fasting. The control phase includes 3 days of habitual energy balance assessment before coming into the laboratory for baseline meal testing with blood, muscle, and adipose samples as well as anthropometric assessment.
Participants will then be provided with a standardised lunch to be consumed around midday and a standardised dinner to be consumed at 2000 h.
Participants will then be asked to refrain from caloric intake for 3 days until they return to the laboratory for follow up measures.
Participants will be provided with monitoring equipment throughout the 3 days of fasting and will be asked to provide a blood sample at 0800 h each day alongside self recording of blood pressure, weight, and urinary ketones each day. On the middle day (day 2) participants will also be asked to come into the lab to provide a blood sample at 2000 h.
The follow up visit will be identical to that performed before the fast, including meal testing, blood, muscle, and adipose samples.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fasting, Metabolic Disturbance, Energy Supply; Deficiency, Adiposity
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Prolonged Fasting
Arm Type
Experimental
Arm Description
All participants are asked to act as their own control prior to being asked to undergo 3 days of fasting.
Intervention Type
Other
Intervention Name(s)
Prolonged Fasting
Intervention Description
Participants are asked to refrain from caloric intake for 3 days following a period of habitual lifestyle assessment and metabolic assessment.
Primary Outcome Measure Information:
Title
Change in postprandial insulin responses
Description
Change in postprandial insulin (mmol/L) response to a standardised meal before and after 3 days of fasting.
Time Frame
3 days
Secondary Outcome Measure Information:
Title
Change in circulating glycerol and non-esterified fatty acids
Description
Change in indices of lipolysis from adipose tissue in response to prolonged fasting (Glycerol mmol/L; NEFA mmol/L)
Time Frame
1 day, 2 days, 3 days
Title
Change in Autophagy
Description
Change in autophagic flux in response to prolonged fasting, assessed in skeletal muscle and circulating neutrophils.
Time Frame
3 days
Title
Change in plasma lactate
Description
Change in plasma lactate in response to prolonged fasting (indices of Cori cycle)
Time Frame
1 day, 2 days, 3 days
Title
Change in plasma pyruvate
Description
Change in plasma pyruvate in response to prolonged fasting (indices of Cori cycle)
Time Frame
1 day, 2 days, 3 days
Title
Change in ketosis.
Description
Change in urinary (acetoacetate) ketones in response to prolonged fasting.
Time Frame
1 day, 2 days, 3 days.
Title
Change in ketosis.
Description
Change in circulating (beta-hydroxybutyrate) ketones in response to prolonged fasting.
Time Frame
1 day, 2 days, 3 days.
Title
Change in body mass
Description
Change in body mass, pre-post, and during the prolonged fast.
Time Frame
1 day, 2 days, 3 days.
Title
Change in blood pressure
Description
Change in blood pressure pre-, post-, and during the prolonged fast
Time Frame
1 day, 2 days, 3 days.
Title
Change in interstitial fluid glucose concentrations
Description
Change in interstitial fluid glucose concentrations pre-, post-, and during the prolonged fast (assessed via continual glucose monitoring)
Time Frame
1 day, 2 days, 3 days.
Title
Change in amino acid metabolism
Description
Change in amino acid metabolism (i.e. BCAAs and ketoacids) in skeletal muscle
Time Frame
3 days.
Title
Change in amino acid metabolism
Description
Change in amino acid metabolism (i.e. BCAAs and ketoacids) in adipose tissue
Time Frame
3 days.
Title
Change in amino acid metabolism
Description
Change in amino acid metabolism (i.e. BCAAs and ketoacids) in circulation
Time Frame
3 days.
Title
Change in postprandial glucose responses.
Description
Change in postprandial glucose (mmol/L) response to a standardised meal before and after 3 days of fasting.
Time Frame
3 days.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
• Body mass index 20.0-29.9 kg∙m-2
Age 18-45 years
Willing to abstain from food intake for just over 3 days (~82 hours)
Able and willing to provide informed consent and safely comply with study procedures
Females to maintain record of regular menstrual cycle phase or contraceptive use
No anticipated changes in lifestyle during the study (e.g. holidays or exercise programmes)
Exclusion Criteria:
• Any reported condition or behaviour deemed either to pose undue personal risk to the participant or introduce bias
Any diagnosed metabolic disease (e.g. type 1 or type 2 diabetes)
Any reported use of substances which may pose undue personal risk to the participants or introduce bias into the experiment
Pregnancy
Breastfeeding
Lifestyle not conforming to standard sleep-wake cycle (e.g. shift worker)
History of eating disorders (e.g. anorexia)
Any reported recent (<6 months) change in body mass (± 3%)
Uncontrolled hyperthyroidism
Advanced cerebrovascular insufficiency or dementia
Advanced liver or kidney insufficiency
History of migraine and or headache
Psychotic disorders
Unstable or severe coronary artery disease
Retinal detachment
Duodenal or stomach ulcer
Cancer and malignant disease
Regular use of Non-steroidal anti-inflammatory drugs (NSAIDs)
Use of Systemic corticoids
Use of Antihypertensives (especially beta-blockers and diuretics)
Use of Antidiabetics
Use of Anti-coagulants
Use of Psychotropics (especially neuroleptics and lithium)
Use of Anticonvulsants.
Facility Information:
Facility Name
University of Bath
City
Bath
State/Province
Somerset
ZIP/Postal Code
BA2 7AY
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
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Physiological and Sensory Responses to Prolonged Fasting in Humans
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