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Physiological and Sensory Responses to Prolonged Fasting in Humans (PRO-FAST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05977569
Recruitment Status : Active, not recruiting
First Posted : August 4, 2023
Last Update Posted : August 4, 2023
Sponsor:
Collaborator:
University of Nottingham
Information provided by (Responsible Party):
James Betts, University of Bath

Study Description
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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.

Condition or disease Intervention/treatment Phase
Fasting Metabolic Disturbance Energy Supply; Deficiency Adiposity Other: Prolonged Fasting Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 7 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Physiological and Sensory Responses to Prolonged Fasting in Humans
Actual Study Start Date : June 28, 2021
Estimated Primary Completion Date : May 30, 2024
Estimated Study Completion Date : May 30, 2024
Arms and Interventions
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Arm Intervention/treatment
Experimental: Prolonged Fasting
All participants are asked to act as their own control prior to being asked to undergo 3 days of fasting.
 Other: Prolonged Fasting
Participants are asked to refrain from caloric intake for 3 days following a period of habitual lifestyle assessment and metabolic assessment.


Outcome Measures
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Primary Outcome Measures :
  1. Change in postprandial insulin responses [ Time Frame: 3 days ]
    Change in postprandial insulin (mmol/L) response to a standardised meal before and after 3 days of fasting.


Secondary Outcome Measures :
  1. Change in circulating glycerol and non-esterified fatty acids [ Time Frame: 1 day, 2 days, 3 days ]
    Change in indices of lipolysis from adipose tissue in response to prolonged fasting (Glycerol mmol/L; NEFA mmol/L)

  2. Change in Autophagy [ Time Frame: 3 days ]
    Change in autophagic flux in response to prolonged fasting, assessed in skeletal muscle and circulating neutrophils.

  3. Change in plasma lactate [ Time Frame: 1 day, 2 days, 3 days ]
    Change in plasma lactate in response to prolonged fasting (indices of Cori cycle)

  4. Change in plasma pyruvate [ Time Frame: 1 day, 2 days, 3 days ]
    Change in plasma pyruvate in response to prolonged fasting (indices of Cori cycle)

  5. Change in ketosis. [ Time Frame: 1 day, 2 days, 3 days. ]
    Change in urinary (acetoacetate) ketones in response to prolonged fasting.

  6. Change in ketosis. [ Time Frame: 1 day, 2 days, 3 days. ]
    Change in circulating (beta-hydroxybutyrate) ketones in response to prolonged fasting.

  7. Change in body mass [ Time Frame: 1 day, 2 days, 3 days. ]
    Change in body mass, pre-post, and during the prolonged fast.

  8. Change in blood pressure [ Time Frame: 1 day, 2 days, 3 days. ]
    Change in blood pressure pre-, post-, and during the prolonged fast

  9. Change in interstitial fluid glucose concentrations [ Time Frame: 1 day, 2 days, 3 days. ]
    Change in interstitial fluid glucose concentrations pre-, post-, and during the prolonged fast (assessed via continual glucose monitoring)

  10. Change in amino acid metabolism [ Time Frame: 3 days. ]
    Change in amino acid metabolism (i.e. BCAAs and ketoacids) in skeletal muscle

  11. Change in amino acid metabolism [ Time Frame: 3 days. ]
    Change in amino acid metabolism (i.e. BCAAs and ketoacids) in adipose tissue

  12. Change in amino acid metabolism [ Time Frame: 3 days. ]
    Change in amino acid metabolism (i.e. BCAAs and ketoacids) in circulation

  13. Change in postprandial glucose responses. [ Time Frame: 3 days. ]
    Change in postprandial glucose (mmol/L) response to a standardised meal before and after 3 days of fasting.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05977569


Locations
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United Kingdom
University of Bath
Bath, Somerset, United Kingdom, BA2 7AY
Sponsors and Collaborators
University of Bath
University of Nottingham
  Study Documents (Full-Text)

Documents provided by James Betts, University of Bath:
Study Protocol and Statistical Analysis Plan  [PDF] September 23, 2020
Informed Consent Form  [PDF] November 23, 2020

More Information
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Responsible Party: James Betts, Professor, University of Bath
ClinicalTrials.gov Identifier: NCT05977569    
Other Study ID Numbers: PF
First Posted: August 4, 2023    Key Record Dates
Last Update Posted: August 4, 2023
Last Verified: July 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight