Physiological and Sensory Responses to Prolonged Fasting in Humans

Fasting Clinical Trial

— PRO-FAST  

Official title:

Physiological and Sensory Responses to Prolonged Fasting in Humans

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05977569
• Other study ID #: PF
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 28, 2021
• Est. completion date: May 30, 2024

Study information

• Verified date: July 2023
• Source: University of Bath
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 7
• Est. completion date: May 30, 2024
• Est. primary completion date: May 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adiposity
• Energy Supply; Deficiency
• Fasting
• Metabolic Disturbance
• Obesity

Intervention

Other:
• Prolonged Fasting
Participants are asked to refrain from caloric intake for 3 days following a period of habitual lifestyle assessment and metabolic assessment.

Locations

Country	Name	City	State
United Kingdom	University of Bath	Bath	Somerset

Sponsors (2)

Lead Sponsor	Collaborator
University of Bath	University of Nottingham

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in postprandial insulin responses	Change in postprandial insulin (mmol/L) response to a standardised meal before and after 3 days of fasting.	3 days
Secondary	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)	1 day, 2 days, 3 days
Secondary	Change in Autophagy	Change in autophagic flux in response to prolonged fasting, assessed in skeletal muscle and circulating neutrophils.	3 days
Secondary	Change in plasma lactate	Change in plasma lactate in response to prolonged fasting (indices of Cori cycle)	1 day, 2 days, 3 days
Secondary	Change in plasma pyruvate	Change in plasma pyruvate in response to prolonged fasting (indices of Cori cycle)	1 day, 2 days, 3 days
Secondary	Change in ketosis.	Change in urinary (acetoacetate) ketones in response to prolonged fasting.	1 day, 2 days, 3 days.
Secondary	Change in ketosis.	Change in circulating (beta-hydroxybutyrate) ketones in response to prolonged fasting.	1 day, 2 days, 3 days.
Secondary	Change in body mass	Change in body mass, pre-post, and during the prolonged fast.	1 day, 2 days, 3 days.
Secondary	Change in blood pressure	Change in blood pressure pre-, post-, and during the prolonged fast	1 day, 2 days, 3 days.
Secondary	Change in interstitial fluid glucose concentrations	Change in interstitial fluid glucose concentrations pre-, post-, and during the prolonged fast (assessed via continual glucose monitoring)	1 day, 2 days, 3 days.
Secondary	Change in amino acid metabolism	Change in amino acid metabolism (i.e. BCAAs and ketoacids) in skeletal muscle	3 days.
Secondary	Change in amino acid metabolism	Change in amino acid metabolism (i.e. BCAAs and ketoacids) in adipose tissue	3 days.
Secondary	Change in amino acid metabolism	Change in amino acid metabolism (i.e. BCAAs and ketoacids) in circulation	3 days.
Secondary	Change in postprandial glucose responses.	Change in postprandial glucose (mmol/L) response to a standardised meal before and after 3 days of fasting.	3 days.