FastingPRO-FASTNCT05977569
Physiological and Sensory Responses to Prolonged Fasting in Humans
A study testing Prolonged Fasting in people with Fasting and Metabolic Disturbance, run by University of Bath at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Fasting, Metabolic Disturbance, Energy Supply; Deficiency
- What is being tested?
- Prolonged Fasting
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 28 Jun 2021to 30 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- • 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)
Who cannot join
- • 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)
Show all 24Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Fasting, Metabolic Disturbance, Energy Supply; Deficiency, Adiposity
- Being tested
- Prolonged Fasting
- Medical subject headings
- Fasting, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prolonged FastingOther
Participants are asked to refrain from caloric intake for 3 days following a period of habitual lifestyle assessment and metabolic assessment.
| Study group | Role | What they receive |
|---|---|---|
| Prolonged Fasting | Experimental | All participants are asked to act as their own control prior to being asked to undergo 3 days of fasting. Receives: Other: Prolonged Fasting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in postprandial insulin responses
Change in postprandial insulin (mmol/L) response to a standardised meal before and after 3 days of fasting.
Measured: 3 days
Secondary outcomes (13)
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)
Measured: 1 day, 2 days, 3 days
Change in Autophagy
Change in autophagic flux in response to prolonged fasting, assessed in skeletal muscle and circulating neutrophils.
Measured: 3 days
Change in plasma lactate
Change in plasma lactate in response to prolonged fasting (indices of Cori cycle)
Measured: 1 day, 2 days, 3 days
Change in plasma pyruvate
Change in plasma pyruvate in response to prolonged fasting (indices of Cori cycle)
Measured: 1 day, 2 days, 3 days
Change in ketosis.
Change in urinary (acetoacetate) ketones in response to prolonged fasting.
Measured: 1 day, 2 days, 3 days.
Change in ketosis.
Change in circulating (beta-hydroxybutyrate) ketones in response to prolonged fasting.
Measured: 1 day, 2 days, 3 days.
Change in body mass
Change in body mass, pre-post, and during the prolonged fast.
Measured: 1 day, 2 days, 3 days.
Change in blood pressure
Change in blood pressure pre-, post-, and during the prolonged fast
Measured: 1 day, 2 days, 3 days.
Change in interstitial fluid glucose concentrations
Change in interstitial fluid glucose concentrations pre-, post-, and during the prolonged fast (assessed via continual glucose monitoring)
Measured: 1 day, 2 days, 3 days.
Change in amino acid metabolism
Change in amino acid metabolism (i.e. BCAAs and ketoacids) in skeletal muscle
Measured: 3 days.
Change in amino acid metabolism
Change in amino acid metabolism (i.e. BCAAs and ketoacids) in adipose tissue
Measured: 3 days.
Change in amino acid metabolism
Change in amino acid metabolism (i.e. BCAAs and ketoacids) in circulation
Measured: 3 days.
Change in postprandial glucose responses.
Change in postprandial glucose (mmol/L) response to a standardised meal before and after 3 days of fasting.
Measured: 3 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2023
- Study start28 Jun 2021
- Primary completion30 May 2024 (estimated)
- Study completion30 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FastingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bath
- Sponsor type
- University, hospital or other
- Collaborators
- University of Nottingham
- Responsible party
- Principal investigator, James Betts, University of Bath
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05977569
- Sponsor's protocol ID
- PF
- Acronym
- PRO-FAST
- Status last verified
- Jul 2023
- First submitted
- 7 Sep 2021
- Last updated
- 4 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiological and Sensory Responses to Prolonged Fasting in Humans
- ClinicalTrials.gov ID
- NCT05977569
- Acronym / sponsor ID
- PRO-FAST / PF
- Conditions
- Fasting, Metabolic Disturbance, Energy Supply; Deficiency, Adiposity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 7 participants (estimated)
- Lead sponsor
- University of BathUniversity, hospital or other
- Collaborators
- University of Nottingham
- Study start
- 28 Jun 2021 (actual)
- Primary completion
- 30 May 2024 (estimated)
- Study completion
- 30 May 2024 (estimated)
- First posted
- 4 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prolonged Fasting | Experimental | Other: Prolonged FastingAll participants are asked to act as their own control prior to being asked to undergo 3 days of fasting. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- • Body mass index 20.0-29.9 kg∙m-2
Key exclusion criteria (24 listed)
- • Any reported condition or behaviour deemed either to pose undue personal risk to the participant or introduce bias
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prolonged FastingParticipants are asked to refrain from caloric intake for 3 days following a period of habitual lifestyle assessment and metabolic assessment. | Other | Prolonged Fasting |
Primary outcome
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.
13 secondary outcomes
Change in circulating glycerol and non-esterified fatty acids
Time frame: 1 day, 2 days, 3 days
Change in Autophagy
Time frame: 3 days
Change in plasma lactate
Time frame: 1 day, 2 days, 3 days
Change in plasma pyruvate
Time frame: 1 day, 2 days, 3 days
Change in ketosis.
Time frame: 1 day, 2 days, 3 days.
Change in ketosis.
Time frame: 1 day, 2 days, 3 days.
Change in body mass
Time frame: 1 day, 2 days, 3 days.
Change in blood pressure
Time frame: 1 day, 2 days, 3 days.
Change in interstitial fluid glucose concentrations
Time frame: 1 day, 2 days, 3 days.
Change in amino acid metabolism
Time frame: 3 days.
Change in amino acid metabolism
Time frame: 3 days.
Change in amino acid metabolism
Time frame: 3 days.
Change in postprandial glucose responses.
Time frame: 3 days.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prolonged Fasting in people with Fasting and Metabolic Disturbance, run by University of Bath at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in postprandial insulin responses (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2023.