Protein Quality of Chlorella and Fababean Meat AnalogueGiant LeapsNCT06436937
Protein Quality of Fava Bean and Honey Chlorella in Humans
A study testing Single meal containing 20 g of 15N intrinsically labelled protein from honey chlorella and Single meal containing 20 g of 15N intrinsically labelled protein from faba bean meat analogue in people with Protein Quality of Chlorella and Fababean Meat Analogue, run by Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Protein Quality of Chlorella and Fababean Meat Analogue
- What is being tested?
- Single meal containing 20 g of 15N intrinsically labelled protein from honey chlorella and Single meal containing 20 g of 15N intrinsically labelled protein from faba bean meat analogue
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteFrance
- Study dates
- 13 Jun 2024to 2 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18<BMI<30
- Good health (WHO=0)
- For woman: use of birth control
Who cannot join
- food allergy
- allergy against latex
- pregnant women
- Positive serology for AgHBS, AcHbc, HCV, HIV
- Anemia
- Excessive alcohool consumption
Show all 10Show fewer
- Hypertension, diabetes, digestive, hepatic or renal diseases, cardiac disease
- Exercice>7h/week
- Blood donation within 3 months before the study
- Participation to another clinical study within 3 months before the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Gheorghe Airinei, MD contact
France1 site, 1 recruiting
- Recruiting
Research Center on Volunteers
Bobigny, 93000
Claire Gaudichon, 33 1 89 10 08 52, claire.gaudichon@agroparistech.fr
About this study
Official title: Protein Quality of Fava Bean Meat Analogue and Honey Chlorella Ingested as Mixed Meals in Healthy Volunteers
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.
Read the 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 (1.3 g protein/kg 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 5g/kg 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 (20g/l), will start at a flow rate of 1ml/min. The intestinal flow and the basal ileal sample will be collected during 30 min. Basal plasma sample will be sampled.
Then, at t=0, the volunteers will drink the test-meal. Until t=8h, 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 110°C 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
- Being tested
- Single meal containing 20 g of 15N intrinsically labelled protein from honey chlorella, Single meal containing 20 g of 15N intrinsically labelled protein from faba bean meat analogue
- Keywords
- Digestibility, healthy humans, nasoileal tubes, stable isotopes, nitrogen retention, postprandial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single meal containing 20 g of 15N intrinsically labelled protein from honey chlorellaDietary supplement
Ingestion of a 15N labeled test meal. Subjects are equipped with a nasoileal tube. 15N is followed in biological fluids (plasma, effluents, urines).
Single meal containing 20 g of 15N intrinsically labelled protein from faba bean meat analogueDietary supplement
Ingestion of a 15N labeled test meal. Subjects are equipped with a nasoileal tube. 15N is followed in biological fluids (plasma, effluents, urines).
| Study group | Role | What they receive |
|---|---|---|
| Honey Chlorella | Experimental | The subjects ingest a single meal: a drink including 40 g of honey chlorella intrinsically labelled with 15N, to provide 20g protein from chlorella Receives: Dietary Supplement: Single meal containing 20 g of 15N intrinsically labelled protein from honey chlorella |
| Faba bean meat analogue | Experimental | The subjects ingest a single meal: a mixed meal including 80 g of faba bean meat analogue intrinsically labelled with 15N, to provide 20g protein from faba bean Receives: Dietary Supplement: Single meal containing 20 g of 15N intrinsically labelled protein from faba bean meat analogue |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ileal digestibility of protein and amino acids
The measurement of nitrogen (mmol) and 15N enrichment (atom %) in ileal samples allow to determine the amount of dietary nitrogen in the lumen. Dietary nitrogen that is recovered in the ileal samples are then considered as non absorbed.
Measured: -30 minutes to 8 hours after the test meal
Net Postprandial Protein Utilization (NPPU)
The measurement of urea (mmol) and 15N enrichment of urea (atom %) allow to determine the amount of dietary N that was transferred to urea, thus accounting for metabolic losses. Metabolic losses of dietary N, together with digestive losses of dietary N, are not retained in the body.
Measured: 0 to 8 hours after the test meal
Ileal digestibility of amino acids
The measurement of amino acid concentration (mmol) and their individual 15N enrichment (atom %) allow the determination of dietary amino acids remaining in the lumen. Dietary amino acids that are recovered in the ileal samples are then considered as non absorbed.
Measured: -30 minutes to 8 hours after the test meal
Secondary outcomes (5)
Nitrogen metabolites in blood in response to the ingestion of 15N fava bean
urea and amino acids (mmol/l)
Measured: 0 to 8 hours after the test meal
Plasma glucose in blood in response to the ingestion of 15N fava bean
plasma glucose (mmol/l)
Measured: 0 to 8 hours after the test meal
Plasma insulin in blood in response to the ingestion of 15N fava bean
plasma insulin (pmol/l)
Measured: 0 to 8 hours after the test meal
Ileal microbiota
Microbial DNA sequencing
Measured: -0.5 h before the meal
Peptide composition of ileal digesta
Peptidomic anlaysis by LC-MS
Measured: 0-8 h after the test meal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2024
- Study start13 Jun 2024
- Primary completion2 May 2026 (estimated)
- Study completion2 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Protein Quality of Chlorella and Fababean Meat AnalogueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
- Sponsor type
- University, hospital or other
- Collaborators
- European Commission
- Responsible party
- Principal investigator, Robert Benamouzig, Assistance Publique - Hôpitaux de Paris
- Investigators
- Claire Gaudichon, PhD, Prof, Study director, INRAERobert Benamouzig, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06436937
- Sponsor's protocol ID
- GIANT LEAPS
- Acronym
- Giant Leaps
- Status last verified
- May 2025
- First submitted
- 10 Apr 2024
- Last updated
- 20 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protein Quality of Fava Bean Meat Analogue and Honey Chlorella Ingested as Mixed Meals in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT06436937
- Acronym / sponsor ID
- Giant Leaps / GIANT LEAPS
- Keywords
- Digestibility, healthy humans, nasoileal tubes, stable isotopes, nitrogen retention, postprandial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Institut National de Recherche pour l'Agriculture, l'Alimentation et l'EnvironnementUniversity, hospital or other
- Collaborators
- European Commission
- Study start
- 13 Jun 2024 (actual)
- Primary completion
- 2 May 2026 (estimated)
- Study completion
- 2 Sep 2026 (estimated)
- First posted
- 31 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 (1.3 g protein/kg 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 5g/kg 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 (20g/l), will start at a flow rate of 1ml/min. The intestinal flow and the basal ileal sample will be collected during 30 min. Basal plasma sample will be sampled.
Then, at t=0, the volunteers will drink the test-meal. Until t=8h, 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 110°C 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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Honey Chlorella | Experimental | Dietary Supplement: Single meal containing 20 g of 15N intrinsically labelled protein from honey chlorellaThe subjects ingest a single meal: a drink including 40 g of honey chlorella intrinsically labelled with 15N, to provide 20g protein from chlorella |
| Faba bean meat analogue | Experimental | Dietary Supplement: Single meal containing 20 g of 15N intrinsically labelled protein from faba bean meat analogueThe subjects ingest a single meal: a mixed meal including 80 g of faba bean meat analogue intrinsically labelled with 15N, to provide 20g protein from faba bean |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 18<BMI<30
- Good health (WHO=0)
- For woman: use of birth control
Key exclusion criteria (10 listed)
- food allergy
- allergy against latex
- pregnant women
- Positive serology for AgHBS, AcHbc, HCV, HIV
- Anemia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single meal containing 20 g of 15N intrinsically labelled protein from honey chlorellaIngestion of a 15N labeled test meal. Subjects are equipped with a nasoileal tube. 15N is followed in biological fluids (plasma, effluents, urines). | Dietary supplement | Honey Chlorella |
| Single meal containing 20 g of 15N intrinsically labelled protein from faba bean meat analogueIngestion of a 15N labeled test meal. Subjects are equipped with a nasoileal tube. 15N is followed in biological fluids (plasma, effluents, urines). | Dietary supplement | Faba bean meat analogue |
Primary outcome
Ileal digestibility of protein and amino acids
Time frame: -30 minutes to 8 hours after the test meal
The measurement of nitrogen (mmol) and 15N enrichment (atom %) in ileal samples allow to determine the amount of dietary nitrogen in the lumen. Dietary nitrogen that is recovered in the ileal samples are then considered as non absorbed.
Net Postprandial Protein Utilization (NPPU)
Time frame: 0 to 8 hours after the test meal
The measurement of urea (mmol) and 15N enrichment of urea (atom %) allow to determine the amount of dietary N that was transferred to urea, thus accounting for metabolic losses. Metabolic losses of dietary N, together with digestive losses of dietary N, are not retained in the body.
Ileal digestibility of amino acids
Time frame: -30 minutes to 8 hours after the test meal
The measurement of amino acid concentration (mmol) and their individual 15N enrichment (atom %) allow the determination of dietary amino acids remaining in the lumen. Dietary amino acids that are recovered in the ileal samples are then considered as non absorbed.
5 secondary outcomes
Nitrogen metabolites in blood in response to the ingestion of 15N fava bean
Time frame: 0 to 8 hours after the test meal
Plasma glucose in blood in response to the ingestion of 15N fava bean
Time frame: 0 to 8 hours after the test meal
Plasma insulin in blood in response to the ingestion of 15N fava bean
Time frame: 0 to 8 hours after the test meal
Ileal microbiota
Time frame: -0.5 h before the meal
Peptide composition of ileal digesta
Time frame: 0-8 h after the test meal
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2025.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gheorghe Airinei, MD contact
Claire Gaudichon, PhD, Prof study director
INRAE
Robert Benamouzig, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single meal containing 20 g of 15N intrinsically labelled protein from honey chlorella and Single meal containing 20 g of 15N intrinsically labelled protein from faba bean meat analogue in people with Protein Quality of Chlorella and Fababean Meat Analogue, run by Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Claire Gaudichon, PhD, Prof (33189100852, claire.gaudichon@agroparistech.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ileal digestibility of protein and amino acids (time frame: -30 minutes to 8 hours after the test meal). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2025.