Ignite Creation Date:
2024-05-06 @ 4:52 PM
Last Modification Date:
2024-10-26 @ 2:17 PM
Study NCT ID:
NCT05110664
Status:
UNKNOWN
Last Update Posted:
2021-11-08
First Post:
2021-09-24
Brief Title:
APPETITE linguAl PYY3-36 on aPpEtite and acuTe Energy InTakE
Sponsor:
University College London
Organization:
University College London
Study Overview
Official Title:
A Double-blind Cross-over Placebo-controlled Proof-of-concept Study Using Oral Peptide YY3-36 Solution to Investigate the Mechanistic Role of Lingual PYY in Regulating Appetite Energy Intake and Food Preference in People With OverweightObesity
Status:
UNKNOWN
Status Verified Date:
2021-09
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
APPETITE
Brief Summary:
A double-blind cross-over placebo-controlled proof-of-concept study using oral peptide YY3-36 solution to investigate the mechanistic role of lingual PYY in regulating appetite energy intake and food preference in people with overweightobesity The aim of this study is to investigate the mechanistic role of lingual PYY in regulating appetite energy intake and food preference in people with overweightobesity
Detailed Description:
In order to address the study objective two independent investigations in two separate groups of participants will need to be undertaken to avoid cross-contamination of the results
1 CohortInvestigation 1 A randomised within-subject double-blind cross-over placebo-controlled study to investigate the role of lingual PYY in regulating fasted and post-meal appetite following a fixed energy intake meal
2 CohortInvestigation 2 A randomised within-subject double-blind cross-over placebo-controlled study to investigate the role of lingual PYY in regulating ad libitum energy intake and food preference
People with overweight or obesity BMI 250-399 kgm2 identified via the University College London Hospitals UCLH Bariatric Centre for Weight Management and Metabolic Surgery and through advertising via University College London UCL and ULCH will be invited to take part
Potential participants will initially attend a screening visit where informed written consent will first be taken During the screening visit medical drug and dietary histories will be taken and participant eligibility will be confirmed
Participants will attend on two separate occasions at least 7 days apart for both cohortinvestigation 1 and cohortinvestigation 2 20 participants per cohortinvestigation will be randomised in a 11 manner stratified by sex to receive either oral PYY3-36 solution or matched placebo at their first study visit Participants will be recruited onto studyinvestigation 1 first and once this is complete new subjects will be enrolled onto studyinvestigation 2
CohortIntervention 1 The day prior to each visit participants will complete a 24 hour food diary and appetite scores at home Participants will fast overnight 12 hours and consume only water until reaching the clinical facility the following morning Participants will need to refrain from exercise for 2 days prior to the study visits and from drinking alcohol On arrival medical history will be re-reviewed sociodemographic information collected and a pregnancy test for women of childbearing potential will be performed Body weight and composition will be measured Baseline assessments of fasted subjective appetite assessed using validated visual analogue scales VAS saliva PYY levels via saliva sample and circulating gut hormones via blood sample will be taken
A single dose of lingual PYY GT-001 or placebo will be administered Appetite scores and a paired blood and saliva sample will be collected 10-15 minutes later 30 minutes after study drug application participants will then be asked to consume a standardised fixed meal over 15 minutes using established protocol and appetite scores VAS and saliva and blood samples will be taken for 180 minutes post-meal at regular intervals Participants will be asked to complete 24-hour food diary and appetite scores 6 12 and 24 hours after the study visit
CohortIntervention 2 The day prior to each study visit participants will complete a 24-hour food diary and appetite scores at home Participants will fast overnight 12 hours and consume only water until reaching the clinical facility the following morning Participants will need to refrain from exercise for 2 days prior to the study visits and from drinking alcohol On arrival medical history will be re-reviewed sociodemographic information collected and a pregnancy test for women of childbearing potential will be performed Body weight and composition will be measured Baseline assessments of fasted subjective appetite assessed using validated VAS saliva PYY levels via saliva sample and circulating gut hormones via blood sample will be taken
A single dose of lingual PYY GT-001 or placebo will be administered Appetite scores and a paired blood and saliva sample will be collected 10-15 minutes later 30 minutes after study drug application participants will be offered an extensive free-choice buffet lunch and asked to eat until full Ad libitum energy intake and food preferences will be assessed Participants will be asked to rank likeness of the items of the buffet Appetite scores VAS and paired blood and saliva sample will be taken again 60 minutes from the onset of the meal Participants will be asked to complete 24-hour food diary and appetite scores 24 hours after the study visit
After a 7-day washout period participants in each cohortintervention will be crossed-over and the same visit will be repeated Both the participants and researchers will be blinded to the study condition
1 CohortInvestigation 1 A randomised within-subject double-blind cross-over placebo-controlled study to investigate the role of lingual PYY in regulating fasted and post-meal appetite following a fixed energy intake meal
2 CohortInvestigation 2 A randomised within-subject double-blind cross-over placebo-controlled study to investigate the role of lingual PYY in regulating ad libitum energy intake and food preference
People with overweight or obesity BMI 250-399 kgm2 identified via the University College London Hospitals UCLH Bariatric Centre for Weight Management and Metabolic Surgery and through advertising via University College London UCL and ULCH will be invited to take part
Potential participants will initially attend a screening visit where informed written consent will first be taken During the screening visit medical drug and dietary histories will be taken and participant eligibility will be confirmed
Participants will attend on two separate occasions at least 7 days apart for both cohortinvestigation 1 and cohortinvestigation 2 20 participants per cohortinvestigation will be randomised in a 11 manner stratified by sex to receive either oral PYY3-36 solution or matched placebo at their first study visit Participants will be recruited onto studyinvestigation 1 first and once this is complete new subjects will be enrolled onto studyinvestigation 2
CohortIntervention 1 The day prior to each visit participants will complete a 24 hour food diary and appetite scores at home Participants will fast overnight 12 hours and consume only water until reaching the clinical facility the following morning Participants will need to refrain from exercise for 2 days prior to the study visits and from drinking alcohol On arrival medical history will be re-reviewed sociodemographic information collected and a pregnancy test for women of childbearing potential will be performed Body weight and composition will be measured Baseline assessments of fasted subjective appetite assessed using validated visual analogue scales VAS saliva PYY levels via saliva sample and circulating gut hormones via blood sample will be taken
A single dose of lingual PYY GT-001 or placebo will be administered Appetite scores and a paired blood and saliva sample will be collected 10-15 minutes later 30 minutes after study drug application participants will then be asked to consume a standardised fixed meal over 15 minutes using established protocol and appetite scores VAS and saliva and blood samples will be taken for 180 minutes post-meal at regular intervals Participants will be asked to complete 24-hour food diary and appetite scores 6 12 and 24 hours after the study visit
CohortIntervention 2 The day prior to each study visit participants will complete a 24-hour food diary and appetite scores at home Participants will fast overnight 12 hours and consume only water until reaching the clinical facility the following morning Participants will need to refrain from exercise for 2 days prior to the study visits and from drinking alcohol On arrival medical history will be re-reviewed sociodemographic information collected and a pregnancy test for women of childbearing potential will be performed Body weight and composition will be measured Baseline assessments of fasted subjective appetite assessed using validated VAS saliva PYY levels via saliva sample and circulating gut hormones via blood sample will be taken
A single dose of lingual PYY GT-001 or placebo will be administered Appetite scores and a paired blood and saliva sample will be collected 10-15 minutes later 30 minutes after study drug application participants will be offered an extensive free-choice buffet lunch and asked to eat until full Ad libitum energy intake and food preferences will be assessed Participants will be asked to rank likeness of the items of the buffet Appetite scores VAS and paired blood and saliva sample will be taken again 60 minutes from the onset of the meal Participants will be asked to complete 24-hour food diary and appetite scores 24 hours after the study visit
After a 7-day washout period participants in each cohortintervention will be crossed-over and the same visit will be repeated Both the participants and researchers will be blinded to the study condition
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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?:
None