xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05977569</url>
    </required_header>
    <id_info>
      <org_study_id>PF</org_study_id>
      <nct_id>NCT05977569</nct_id>
    </id_info>
    <brief_title>Physiological and Sensory Responses to Prolonged Fasting in Humans</brief_title>
    <acronym>PRO-FAST</acronym>
    <official_title>Physiological and Sensory Responses to Prolonged Fasting in Humans</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Bath</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>University of Nottingham</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Bath</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study aims to establish the metabolic/molecular response in both adipose tissue and&#xD;
        skeletal muscle as well as sensory experiences (pain, fatigue, drive) to prolonged fasting of&#xD;
        3 days duration. Participants will undergo sequential meal assessment before and after a 3&#xD;
        day fast with measures taken throughout each fasting day.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study will employ a single-arm, non-randomised design in which participants will act as&#xD;
        their own control prior to undergoing 3 days of fasting. The control phase includes 3 days of&#xD;
        habitual energy balance assessment before coming into the laboratory for baseline meal&#xD;
        testing with blood, muscle, and adipose samples as well as anthropometric assessment.&#xD;
  &#xD;
        Participants will then be provided with a standardised lunch to be consumed around midday and&#xD;
        a standardised dinner to be consumed at 2000 h.&#xD;
  &#xD;
        Participants will then be asked to refrain from caloric intake for 3 days until they return&#xD;
        to the laboratory for follow up measures.&#xD;
  &#xD;
        Participants will be provided with monitoring equipment throughout the 3 days of fasting and&#xD;
        will be asked to provide a blood sample at 0800 h each day alongside self recording of blood&#xD;
        pressure, weight, and urinary ketones each day. On the middle day (day 2) participants will&#xD;
        also be asked to come into the lab to provide a blood sample at 2000 h.&#xD;
  &#xD;
        The follow up visit will be identical to that performed before the fast, including meal&#xD;
        testing, blood, muscle, and adipose samples.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">June 28, 2021</start_date>
    <completion_date type="Anticipated">May 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">May 30, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Basic Science</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in postprandial insulin responses</measure>
      <time_frame>3 days</time_frame>
      <description>Change in postprandial insulin (mmol/L) response to a standardised meal before and after 3 days of fasting.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in circulating glycerol and non-esterified fatty acids</measure>
      <time_frame>1 day, 2 days, 3 days</time_frame>
      <description>Change in indices of lipolysis from adipose tissue in response to prolonged fasting (Glycerol mmol/L; NEFA mmol/L)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Autophagy</measure>
      <time_frame>3 days</time_frame>
      <description>Change in autophagic flux in response to prolonged fasting, assessed in skeletal muscle and circulating neutrophils.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in plasma lactate</measure>
      <time_frame>1 day, 2 days, 3 days</time_frame>
      <description>Change in plasma lactate in response to prolonged fasting (indices of Cori cycle)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in plasma pyruvate</measure>
      <time_frame>1 day, 2 days, 3 days</time_frame>
      <description>Change in plasma pyruvate in response to prolonged fasting (indices of Cori cycle)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in ketosis.</measure>
      <time_frame>1 day, 2 days, 3 days.</time_frame>
      <description>Change in urinary (acetoacetate) ketones in response to prolonged fasting.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in ketosis.</measure>
      <time_frame>1 day, 2 days, 3 days.</time_frame>
      <description>Change in circulating (beta-hydroxybutyrate) ketones in response to prolonged fasting.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in body mass</measure>
      <time_frame>1 day, 2 days, 3 days.</time_frame>
      <description>Change in body mass, pre-post, and during the prolonged fast.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in blood pressure</measure>
      <time_frame>1 day, 2 days, 3 days.</time_frame>
      <description>Change in blood pressure pre-, post-, and during the prolonged fast</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in interstitial fluid glucose concentrations</measure>
      <time_frame>1 day, 2 days, 3 days.</time_frame>
      <description>Change in interstitial fluid glucose concentrations pre-, post-, and during the prolonged fast (assessed via continual glucose monitoring)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in amino acid metabolism</measure>
      <time_frame>3 days.</time_frame>
      <description>Change in amino acid metabolism (i.e. BCAAs and ketoacids) in skeletal muscle</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in amino acid metabolism</measure>
      <time_frame>3 days.</time_frame>
      <description>Change in amino acid metabolism (i.e. BCAAs and ketoacids) in adipose tissue</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in amino acid metabolism</measure>
      <time_frame>3 days.</time_frame>
      <description>Change in amino acid metabolism (i.e. BCAAs and ketoacids) in circulation</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in postprandial glucose responses.</measure>
      <time_frame>3 days.</time_frame>
      <description>Change in postprandial glucose (mmol/L) response to a standardised meal before and after 3 days of fasting.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">7</enrollment>
    <condition>Fasting</condition>
    <condition>Metabolic Disturbance</condition>
    <condition>Energy Supply; Deficiency</condition>
    <condition>Adiposity</condition>
    <arm_group>
      <arm_group_label>Prolonged Fasting</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>All participants are asked to act as their own control prior to being asked to undergo 3 days of fasting.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Prolonged Fasting</intervention_name>
      <description>Participants are asked to refrain from caloric intake for 3 days following a period of habitual lifestyle assessment and metabolic assessment.</description>
      <arm_group_label>Prolonged Fasting</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  • Body mass index 20.0-29.9 kg∙m-2&#xD;
  &#xD;
                 -  Age 18-45 years&#xD;
  &#xD;
                 -  Willing to abstain from food intake for just over 3 days (~82 hours)&#xD;
  &#xD;
                 -  Able and willing to provide informed consent and safely comply with study&#xD;
                    procedures&#xD;
  &#xD;
                 -  Females to maintain record of regular menstrual cycle phase or contraceptive use&#xD;
  &#xD;
                 -  No anticipated changes in lifestyle during the study (e.g. holidays or exercise&#xD;
                    programmes)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  • Any reported condition or behaviour deemed either to pose undue personal risk to the&#xD;
               participant or introduce bias&#xD;
  &#xD;
                 -  Any diagnosed metabolic disease (e.g. type 1 or type 2 diabetes)&#xD;
  &#xD;
                 -  Any reported use of substances which may pose undue personal risk to the&#xD;
                    participants or introduce bias into the experiment&#xD;
  &#xD;
                 -  Pregnancy&#xD;
  &#xD;
                 -  Breastfeeding&#xD;
  &#xD;
                 -  Lifestyle not conforming to standard sleep-wake cycle (e.g. shift worker)&#xD;
  &#xD;
                 -  History of eating disorders (e.g. anorexia)&#xD;
  &#xD;
                 -  Any reported recent (&lt;6 months) change in body mass (± 3%)&#xD;
  &#xD;
                 -  Uncontrolled hyperthyroidism&#xD;
  &#xD;
                 -  Advanced cerebrovascular insufficiency or dementia&#xD;
  &#xD;
                 -  Advanced liver or kidney insufficiency&#xD;
  &#xD;
                 -  History of migraine and or headache&#xD;
  &#xD;
                 -  Psychotic disorders&#xD;
  &#xD;
                 -  Unstable or severe coronary artery disease&#xD;
  &#xD;
                 -  Retinal detachment&#xD;
  &#xD;
                 -  Duodenal or stomach ulcer&#xD;
  &#xD;
                 -  Cancer and malignant disease&#xD;
  &#xD;
                 -  Regular use of Non-steroidal anti-inflammatory drugs (NSAIDs)&#xD;
  &#xD;
                 -  Use of Systemic corticoids&#xD;
  &#xD;
                 -  Use of Antihypertensives (especially beta-blockers and diuretics)&#xD;
  &#xD;
                 -  Use of Antidiabetics&#xD;
  &#xD;
                 -  Use of Anti-coagulants&#xD;
  &#xD;
                 -  Use of Psychotropics (especially neuroleptics and lithium)&#xD;
  &#xD;
                 -  Use of Anticonvulsants.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>45 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>University of Bath</name>
        <address>
          <city>Bath</city>
          <state>Somerset</state>
          <zip>BA2 7AY</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United Kingdom</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>September 7, 2021</study_first_submitted>
    <study_first_submitted_qc>July 26, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>July 26, 2023</last_update_submitted>
    <last_update_submitted_qc>July 26, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 4, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Bath</investigator_affiliation>
      <investigator_full_name>James Betts</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Obesity</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <provided_document_section>
      <provided_document>
        <document_type>Study Protocol and Statistical Analysis Plan</document_type>
        <document_has_protocol>Yes</document_has_protocol>
        <document_has_icf>No</document_has_icf>
        <document_has_sap>Yes</document_has_sap>
        <document_date>September 23, 2020</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/69/NCT05977569/Prot_SAP_000.pdf</document_url>
      </provided_document>
      <provided_document>
        <document_type>Informed Consent Form</document_type>
        <document_has_protocol>No</document_has_protocol>
        <document_has_icf>Yes</document_has_icf>
        <document_has_sap>No</document_has_sap>
        <document_date>November 23, 2020</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/69/NCT05977569/ICF_001.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05977569
  org study id: PF
  nct id: NCT05977569
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Basic Science
  masking: None (Open Label)
  measure: Change in postprandial insulin responses
  time frame: 3 days
  description: Change in postprandial insulin (mmol/L) response to a standardised meal before and after 3 days of fasting.
  measure: Change in circulating glycerol and non-esterified fatty acids
  time frame: 1 day, 2 days, 3 days
  description: Change in indices of lipolysis from adipose tissue in response to prolonged fasting (Glycerol mmol/L; NEFA mmol/L)
  measure: Change in Autophagy
  time frame: 3 days
  description: Change in autophagic flux in response to prolonged fasting, assessed in skeletal muscle and circulating neutrophils.
  measure: Change in plasma lactate
  time frame: 1 day, 2 days, 3 days
  description: Change in plasma lactate in response to prolonged fasting (indices of Cori cycle)
  measure: Change in plasma pyruvate
  time frame: 1 day, 2 days, 3 days
  description: Change in plasma pyruvate in response to prolonged fasting (indices of Cori cycle)
  measure: Change in ketosis.
  time frame: 1 day, 2 days, 3 days.
  description: Change in urinary (acetoacetate) ketones in response to prolonged fasting.
  measure: Change in ketosis.
  time frame: 1 day, 2 days, 3 days.
  description: Change in circulating (beta-hydroxybutyrate) ketones in response to prolonged fasting.
  measure: Change in body mass
  time frame: 1 day, 2 days, 3 days.
  description: Change in body mass, pre-post, and during the prolonged fast.
  measure: Change in blood pressure
  time frame: 1 day, 2 days, 3 days.
  description: Change in blood pressure pre-, post-, and during the prolonged fast
  measure: Change in interstitial fluid glucose concentrations
  time frame: 1 day, 2 days, 3 days.
  description: Change in interstitial fluid glucose concentrations pre-, post-, and during the prolonged fast (assessed via continual glucose monitoring)
  measure: Change in amino acid metabolism
  time frame: 3 days.
  description: Change in amino acid metabolism (i.e. BCAAs and ketoacids) in skeletal muscle
  measure: Change in amino acid metabolism
  time frame: 3 days.
  description: Change in amino acid metabolism (i.e. BCAAs and ketoacids) in adipose tissue
  measure: Change in amino acid metabolism
  time frame: 3 days.
  description: Change in amino acid metabolism (i.e. BCAAs and ketoacids) in circulation
  measure: Change in postprandial glucose responses.
  time frame: 3 days.
  description: Change in postprandial glucose (mmol/L) response to a standardised meal before and after 3 days of fasting.
  arm group label: Prolonged Fasting
  arm group type: Experimental
  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: Prolonged Fasting
  description: Participants are asked to refrain from caloric intake for 3 days following a period of habitual lifestyle assessment and metabolic assessment.
  arm group label: Prolonged Fasting
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 45 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: United Kingdom
  responsible party type: Principal Investigator
  investigator affiliation: University of Bath
  investigator full name: James Betts
  investigator title: Professor
  mesh term: Obesity
  sharing ipd: No
  provided document: 
  provided document: 