Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06436937
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-31
First Post:
2024-04-10
Brief Title:
Protein Quality of Fava Bean and Honey Chlorella in Humans
Sponsor:
Institut National de Recherche pour lAgriculture lAlimentation et lEnvironnement
Organization:
Institut National de Recherche pour lAgriculture lAlimentation et lEnvironnement
Study Overview
Official Title:
Protein Quality of Fava Bean Meat Analogue and Honey Chlorella Ingested as Mixed Meals in Healthy Volunteers
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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:
Giant Leaps
Brief Summary:
The goal of the project is to determine the protein quality of alternative protein sources honey chlorella and Faba bean ingested as mixed meals in healthy subjects equipped with naso-ileal tube For this purpose Chlorella and Faba bean are intrinsically labelled with 15N Faba bean is processed to produce a meat analogue Chlorella is introduced in a drink The protein quality is determined by following the digestive and metabolic fate of 15N during a 8h postprandial investigation
Detailed Description:
The objective is to determine the nutritional quality of protein from honey chlorella and faba bean meat analogue in healthy humans especially in terms of protein and amino acid digestibility as well as nitrogen retention Ileal digestibility is determined in ileal digesta collected postprandially with a naso-ileal tube The protein sources are intrinsically labelled in 15N in order to track dietary nitrogen and amino acids in the samples
Ethical and regulatory aspects
The protocol has been approved to the Ethical Committee and authorized the French Agency of Drugs and Health The personal data management will be in accordance with the regulation on personal data protection regulation n 2018-493 du 20 juin 2018
Meal
The meal will consist in either a drink containing 40 g of honey chlorella or a mixed meal containiong 80 g of meat analogue to provide 20 g protein Sensory tests will be realized to optimize the organoleptic properties of the meal
Volunteers
Sixteen subjects will be included in the study The investigators plan to recruit around 40 volunteers to accommodate for the usual 60 dropouts
Four days before the experiment the volunteers will follow a standard diet adapted to their body weight to control their protein intake 13 g proteinkg body weight
The volunteers will arrive at the Human Nutrition Research Centre of Avicenne Hospital on the morning before the day of the experiment They will be equipped with a double lumen intestinal tube that will be allowed to progress through the intestinal tract for 24h One of the lumen is radio opaque and serves to perfuse a non-absorbable maker in the intestine slow marker method The other lumen is dedicated to the continuous aspiration of the effluents 15 cm below the perfusion site The measurement of the non-absorbable marker in the effluents allows the determination of the effluent flow rate
On the evening before the experimental day they will ingest 3 oral doses of deuterated water 99 to reach 5gkg total body water to label the intestinal endogenous proteins
On the day of the experiment the position of the tube will be checked by radiography to verify its location at the terminal ileum A catheter will be inserted in the forearm vein for blood sampling The perfusion of the non-absorbable marker PEG-4000 20gl will start at a flow rate of 1mlmin The intestinal flow and the basal ileal sample will be collected during 30 min Basal plasma sample will be sampled
Then at t0 the volunteers will drink the test-meal Until t8h intestinal content will be continuously collected by aspiration and pooled every 30 minutes Blood will be sampled every 30 minutes during 4h and hourly thereafter The urine will be collected every 2 h for 8 h
Measurements
In the ilel digesta
PEG-4000 by turbidimetric method total N and 15N enrichment by EA-IRMS amino acid concentrations by UPLC after acid hydrolysis HCl 6N at 110C for 24h 15N amino acid enrichment by GC-c-IRMS after purification on cation exchange resin and derivatization 2H amino acid enrichment by GC-c-IRMS microbiome analysis DNA sequencing peptide analysis LC-MS
In the plasma
Glucose urea colorimetric methods insulin ELISA amino acid concentrations UPLC 15N enrichment in plasma protein urea and free amino acids EA-IRMS after purification on cation exchange resin and derivatization
In the urine
Urea colorimetric method and 15N urea EA-IRMS after purification on cation exchange resin and derivatization
Main outcomes are
Real ileal digestibility of protein and amino acids digestive losses Postprandial deamination metabolic losses Net Postprandial Protein Utilization
Ethical and regulatory aspects
The protocol has been approved to the Ethical Committee and authorized the French Agency of Drugs and Health The personal data management will be in accordance with the regulation on personal data protection regulation n 2018-493 du 20 juin 2018
Meal
The meal will consist in either a drink containing 40 g of honey chlorella or a mixed meal containiong 80 g of meat analogue to provide 20 g protein Sensory tests will be realized to optimize the organoleptic properties of the meal
Volunteers
Sixteen subjects will be included in the study The investigators plan to recruit around 40 volunteers to accommodate for the usual 60 dropouts
Four days before the experiment the volunteers will follow a standard diet adapted to their body weight to control their protein intake 13 g proteinkg body weight
The volunteers will arrive at the Human Nutrition Research Centre of Avicenne Hospital on the morning before the day of the experiment They will be equipped with a double lumen intestinal tube that will be allowed to progress through the intestinal tract for 24h One of the lumen is radio opaque and serves to perfuse a non-absorbable maker in the intestine slow marker method The other lumen is dedicated to the continuous aspiration of the effluents 15 cm below the perfusion site The measurement of the non-absorbable marker in the effluents allows the determination of the effluent flow rate
On the evening before the experimental day they will ingest 3 oral doses of deuterated water 99 to reach 5gkg total body water to label the intestinal endogenous proteins
On the day of the experiment the position of the tube will be checked by radiography to verify its location at the terminal ileum A catheter will be inserted in the forearm vein for blood sampling The perfusion of the non-absorbable marker PEG-4000 20gl will start at a flow rate of 1mlmin The intestinal flow and the basal ileal sample will be collected during 30 min Basal plasma sample will be sampled
Then at t0 the volunteers will drink the test-meal Until t8h intestinal content will be continuously collected by aspiration and pooled every 30 minutes Blood will be sampled every 30 minutes during 4h and hourly thereafter The urine will be collected every 2 h for 8 h
Measurements
In the ilel digesta
PEG-4000 by turbidimetric method total N and 15N enrichment by EA-IRMS amino acid concentrations by UPLC after acid hydrolysis HCl 6N at 110C for 24h 15N amino acid enrichment by GC-c-IRMS after purification on cation exchange resin and derivatization 2H amino acid enrichment by GC-c-IRMS microbiome analysis DNA sequencing peptide analysis LC-MS
In the plasma
Glucose urea colorimetric methods insulin ELISA amino acid concentrations UPLC 15N enrichment in plasma protein urea and free amino acids EA-IRMS after purification on cation exchange resin and derivatization
In the urine
Urea colorimetric method and 15N urea EA-IRMS after purification on cation exchange resin and derivatization
Main outcomes are
Real ileal digestibility of protein and amino acids digestive losses Postprandial deamination metabolic losses Net Postprandial Protein Utilization
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