Physiological and Sensory Responses to Prolonged Fasting in Humans

NCT05977569 | Unknown

• 1 other identifier: PF
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Fasting; Metabolic Disturbance; Energy Supply; Deficiency; Adiposity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Change in circulating glycerol and non-esterified fatty acids

  1 day, 2 days, 3 days

• Change in Autophagy

  3 days

• Change in plasma lactate

  1 day, 2 days, 3 days

• Change in plasma pyruvate

  1 day, 2 days, 3 days

• Change in ketosis.

  1 day, 2 days, 3 days.

Study Arms (1)

Prolonged Fasting

EXPERIMENTAL

All participants are asked to act as their own control prior to being asked to undergo 3 days of fasting.

Other: Prolonged Fasting

Interventions

Prolonged Fasting OTHER

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

Prolonged Fasting

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Bath: lead
• University of Nottingham: collaborator

Study Sites (1)

University of Bath

Bath, Somerset, BA2 7AY, United Kingdom

Location

MeSH Terms

Conditions

Fasting; Obesity

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 7, 2021
• First Posted: August 4, 2023
• Study Start: June 28, 2021
• Primary Completion: May 30, 2024
• Study Completion: May 30, 2024
• Last Updated: August 4, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)