Status:

UNKNOWN

Physiological and Sensory Responses to Prolonged Fasting in Humans

Lead Sponsor:

University of Bath

Collaborating Sponsors:

University of Nottingham

Conditions:

Fasting

Metabolic Disturbance

Eligibility:

All Genders

18-45 years

Phase:

NA

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. ...

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 ener...

Eligibility Criteria

Inclusion

  • • 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

  • • 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.

Key Trial Info

Start Date :

June 28 2021

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

May 30 2024

Estimated Enrollment :

7 Patients enrolled

Trial Details

Trial ID

NCT05977569

Start Date

June 28 2021

End Date

May 30 2024

Last Update

August 4 2023

Active Locations (1)

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Page 1 of 1 (1 locations)

1

University of Bath

Bath, Somerset, United Kingdom, BA2 7AY

Physiological and Sensory Responses to Prolonged Fasting in Humans | DecenTrialz