Ignite Creation Date:
2024-07-17 @ 10:42 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06480799
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-28
First Post:
2024-06-24
Brief Title:
Effect of Pectin and Inulin Fibre Supplementation on Glucose and ANS Modulation
Sponsor:
Elizabeth Simpson
Organization:
University of Nottingham
Study Overview
Official Title:
The Role of Dietary Fibres in Modulating Blood Glucose and the Autonomic Nervous System - A Pilot Randomised Placebo-controlled Dietary Intervention Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
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:
None
Brief Summary:
The study involves intake of dietary supplements which are commonly found in the UK diet not pharmacological agents to test their effects on inflammation in the body and gut microbiome composition Study subjects will be healthy volunteers recruited from the University and local population and will be asked to attend the laboratory on 2 occasions before and after 4-week supplementing the diet daily with either the dietary fibres Pectin and Inulin or placebo maltodextrin At each study visit 3hrs participants will be asked to provide a stool and blood sample and will have blood pressure measured They will also consume a glucose drink to assess how effectively the body regulates its blood glucose concentration In the week before each study visit participants will wear an activity and glucose monitor and record their food intake
Detailed Description:
The overall aim of the proposed project is to unlock the effect of two structurally different dietary fibres on anti-inflammatory and cardioprotective metabolic responses via the modulation of the gut microbiome and SCFAs production
Specific Aim 1 To deliver a wealth of molecular data including effect sizes on the physiological effects of two distinct fibres on the changes in the composition and function of the gut microbiome and changes in the metabolomic and physiological profile of an individual
Specific Aim 2 To investigate the mechanisms whereby the gut microbiome modulates crucial physiological parameters such blood glucose regulation hunger and appetite immune function markers in response to the anti-inflammatory effects of the gut microbiome
30 healthy non obese volunteers will be recruited following a successful medical screening Between recruitment and first study visit and in the final week of the 4-week intervention before the second study visit participants will be asked to wear a wrist-worn activity monitor and a subcutaneous glucose monitor Freestyle Libre 2 7 days to complete a dietary record 4 days to collect a stool sample on the day before the study visit and to fast from midnight the night before this visit
At both study visits participants will have weight hipwaist circumference and blood pressure measured They will consume 75g of glucose in 300ml of water as an oral glucose challenge and glucose concentration will be monitored over 2 hours via the subcutaneous monitor They will also be asked to complete some questionnaires After completion of the first study day participants will be randomised to receive either the dietary fibres or placebo powder They will be given the blinded products portioned in individual sachets with instructions to add the contents of one sachet a day to juice smoothies or water and to consume immediately Study visit 2 will be scheduled at the end of the 4 week dosing period
Specific Aim 1 To deliver a wealth of molecular data including effect sizes on the physiological effects of two distinct fibres on the changes in the composition and function of the gut microbiome and changes in the metabolomic and physiological profile of an individual
Specific Aim 2 To investigate the mechanisms whereby the gut microbiome modulates crucial physiological parameters such blood glucose regulation hunger and appetite immune function markers in response to the anti-inflammatory effects of the gut microbiome
30 healthy non obese volunteers will be recruited following a successful medical screening Between recruitment and first study visit and in the final week of the 4-week intervention before the second study visit participants will be asked to wear a wrist-worn activity monitor and a subcutaneous glucose monitor Freestyle Libre 2 7 days to complete a dietary record 4 days to collect a stool sample on the day before the study visit and to fast from midnight the night before this visit
At both study visits participants will have weight hipwaist circumference and blood pressure measured They will consume 75g of glucose in 300ml of water as an oral glucose challenge and glucose concentration will be monitored over 2 hours via the subcutaneous monitor They will also be asked to complete some questionnaires After completion of the first study day participants will be randomised to receive either the dietary fibres or placebo powder They will be given the blinded products portioned in individual sachets with instructions to add the contents of one sachet a day to juice smoothies or water and to consume immediately Study visit 2 will be scheduled at the end of the 4 week dosing period
Study Oversight
Has Oversight DMC:
None
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?:
None