Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2025-12-25 @ 8:18 PM
Study NCT ID:
NCT05977569
Status:
UNKNOWN
Last Update Posted:
2023-08-04
First Post:
2021-09-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Physiological and Sensory Responses to Prolonged Fasting in Humans
Sponsor:
University of Bath
Organization:
Study Overview
Official Title:
Physiological and Sensory Responses to Prolonged Fasting in Humans
Status:
UNKNOWN
Status Verified Date:
2023-07
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRO-FAST
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: