Ignite Creation Date:
2024-05-06 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06161155
Status:
COMPLETED
Last Update Posted:
2024-03-28
First Post:
2023-10-19
Brief Title:
Protein Fermentation Unraveled PROFUN - Exploring the Relationship Between Digestibility and Metabolite Production
Sponsor:
Wageningen University
Organization:
Wageningen University
Study Overview
Official Title:
The PROFUN Study Protein Fermentation Unraveled - Exploring the Relationship Between Digestibility and Metabolite Production
Status:
COMPLETED
Status Verified Date:
2024-03
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:
PROFUN
Brief Summary:
Background of the study
Protein intake is often higher than recommended in Western countries This leads to increased amounts of protein flowing into the large intestine Next to increased dietary protein intake protein digestibility and endogenous protein losses also affect the amount of protein entering the large intestine However these aspects have barely been studied especially in humans The large intestine is home to the largest bacterial ecosystem of the body During the fermentation of protein by these bacteria microbiota metabolites are produced such as ammonia branched-chain fatty acids biogenic amines phenolic compounds indoles and N-nitroso compounds There is evidence that some of these metabolites could be harmful for gut epithelia gastrointestinal health and health in general after they enter blood circulation In general doing measurements inside the gastrointestinal tract is invasive During this project the protein fermentation will be studied in the gastrointestinal tract using feces and urine but also in situ using the GISMO GEN1 ingestible This ingestible contains sensors to measure pH ammonium temperature and redox potential
Objective of the study
The primary objectives of this study are
1 To investigate the feasibility of the GISMO GEN1 System to monitor biomarkers in the gastrointestinal tract by studying the ingestible transit time data coverage participant experience and serious adverse events if applicable
2 To study the effect of a 7-day high versus low digestible protein source present in the diet on protein fermentation in healthy subjects measured by ammonia concentrations
Study design
The study is divided into 2 phases In phase 1 preliminary feasibility of the GISMO GEN1 ingestible system will be assessed and the baseline measurements will be taken without any dietary restrictions An interim analysis will be performed after phase 1 and only after a positive evaluation of the GISMO GEN1 System the study will continue with phase 2
Phase 2 is a randomized cross-over controlled feeding trial Two diets will be used one diet containing a high digestible protein source and the other diet containing a low digestible protein source Each diet will be given for 7 days with a wash-out period in between Measurements done during the dietary interventions will be compared to the other diet and to the baseline measurements
Study population
15 healthy male or female volunteers age 16 or older BMI 185-30
Intervention
A high digestible protein diet 30 gd whey protein and a low digestible protein diet 30 gd bovine plasma protein
Primary study parametersoutcome of the study
Ammonia as biomarker for protein fermentation measured in feces and urine and in situ by the GISMO GEN1 ingestible
Also ingestible transit time data coverage participant experience and serious adverse events
Secundary study parametersoutcome of the study if applicable
Secondary study parameters include other protein fermentation related metabolites measured in feces urine and blood microbiome composition transit time absorption kinetics
Protein intake is often higher than recommended in Western countries This leads to increased amounts of protein flowing into the large intestine Next to increased dietary protein intake protein digestibility and endogenous protein losses also affect the amount of protein entering the large intestine However these aspects have barely been studied especially in humans The large intestine is home to the largest bacterial ecosystem of the body During the fermentation of protein by these bacteria microbiota metabolites are produced such as ammonia branched-chain fatty acids biogenic amines phenolic compounds indoles and N-nitroso compounds There is evidence that some of these metabolites could be harmful for gut epithelia gastrointestinal health and health in general after they enter blood circulation In general doing measurements inside the gastrointestinal tract is invasive During this project the protein fermentation will be studied in the gastrointestinal tract using feces and urine but also in situ using the GISMO GEN1 ingestible This ingestible contains sensors to measure pH ammonium temperature and redox potential
Objective of the study
The primary objectives of this study are
1 To investigate the feasibility of the GISMO GEN1 System to monitor biomarkers in the gastrointestinal tract by studying the ingestible transit time data coverage participant experience and serious adverse events if applicable
2 To study the effect of a 7-day high versus low digestible protein source present in the diet on protein fermentation in healthy subjects measured by ammonia concentrations
Study design
The study is divided into 2 phases In phase 1 preliminary feasibility of the GISMO GEN1 ingestible system will be assessed and the baseline measurements will be taken without any dietary restrictions An interim analysis will be performed after phase 1 and only after a positive evaluation of the GISMO GEN1 System the study will continue with phase 2
Phase 2 is a randomized cross-over controlled feeding trial Two diets will be used one diet containing a high digestible protein source and the other diet containing a low digestible protein source Each diet will be given for 7 days with a wash-out period in between Measurements done during the dietary interventions will be compared to the other diet and to the baseline measurements
Study population
15 healthy male or female volunteers age 16 or older BMI 185-30
Intervention
A high digestible protein diet 30 gd whey protein and a low digestible protein diet 30 gd bovine plasma protein
Primary study parametersoutcome of the study
Ammonia as biomarker for protein fermentation measured in feces and urine and in situ by the GISMO GEN1 ingestible
Also ingestible transit time data coverage participant experience and serious adverse events
Secundary study parametersoutcome of the study if applicable
Secondary study parameters include other protein fermentation related metabolites measured in feces urine and blood microbiome composition transit time absorption kinetics
Detailed Description:
None
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