Healthy Women of Child Bearing PotentialNCT06184984
Metabolic Availability of Methionine in Mung Beans
A study testing Metabolic availability of methionine in mung beans in people with Healthy Women of Child Bearing Potential, run by Food and Nutrition Research Institute, Philippines at 1 site in Philippines.
Trial summary
The goal of this study is to determine the protein quality of Philippine mung beans. The main objective of this study is to determine the metabolic availability of methionine in mung beans that the body can use. We will test the mung beans by studying them after cooking them as sauté. Read more about this study
- Who is it for?
- Ages 19 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Women of Child Bearing Potential
- What is being tested?
- Metabolic availability of methionine in mung beans
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 sitePhilippines
- Study dates
- Apr 2025to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 19 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Non-pregnant
- Non-lactating
- Stable body weight
- Healthy, with no known clinical condition that would affect protein or AA metabolism, e.g. Diabetes
- Not on any medications that could affect protein or amino acid metabolism e.g. steroids.
Who cannot join
- Unwillingness to participate or unable to tolerate the diet
- Recent history of weight loss within the last 3 months or on a weight-reducing diet
- Inability to tolerate study diets (e.g. Allergy to ingredients)
Trial locations and contacts
1 site in 1 country.
Philippines1 site
Department of Science and Technology - Food and Nutrition Research Institute
City of Taguig, National Capital Region, 1630
Myquie Nicole R de Guzman, BS Chemistry, (63) 02 8837-8113 ext. 307, deguzmanmyquie@gmail.com
Ma. Lourdes T Cumagun, Bachelor's, (63) 02 8837-8113 ext. 307, maloucumagun@yahoo.com
About this study
Official title: Metabolic Availability of Methionine in Monggo Meal Among Women of Reproductive Age Using Indicator Amino Acid Oxidation (IAAO)
The goal of this study is to determine the protein quality of Philippine mung beans. The main objective of this study is to determine the metabolic availability of methionine in mung beans that the body can use. We will test the mung beans by studying them after cooking them as sauté.
This research is being done in order to bridge the gap between knowledge of protein requirement and the amount of food needed to meet that requirement. Results from this study will be important for recommendations guiding food choices of mung beans as a major protein source in the diet.
Read more
Each study participant will be part of seven (7) different experimental diets, and randomly assigned to one of the diets every time. Four (4) reference diets would be based on egg protein composition, and three (3) test diets will have protein from cooked mung beans.
Each experimental diet will be studied over 3 days: 2 adaptation days and 1 study day. The meals during the 2-day adaptation period would be consumed at home. On the study day, following a 10 to 12-h overnight fast, the study participants will come to the research unit at the Department of Science - Food and Nutrition Research Institute (DOST-FNRI), Gen. Santos Ave., Bicutan, Taguig City, Philippines, for a period of 8 to 9 hours and consume the diets as 9 hourly meals.
Read the detailed description
The pre-study assessments will include the measurement of Basal Metabolic Rate (BMR) / Resting Energy Expenditure (REE) by open-circuit indirect calorimetry, and body composition (fat and fat-free mass) by deuterium oxide dilution technique.
The study protocol is a 3-day experimental protocol (2 days of adaptation plus 1 study day), with an interval of ≥1 week to ensure complete tracer washout.
Each participant is adapted to the test diets for two days to provide them with adequate energy and protein (isonitrogenous diet), and to stabilize their metabolic pool. The energy during the adaptation period is provided at resting energy expenditure (REE/BMR) x 1.7 and protein 1.0 g.kg-1.d-1. During this period, each participant will be expected to consume 4 meals per day consisting of a protein liquid drink and protein free-cookies and/or cooked mung bean meal, which the investigators will provide.
On the study day, after a 10-12 h overnight fast, the participants will come to the research unit for 8-9 h, and receive 9 isonitrogenous, isocaloric hourly meals, each representing one-tenth of the participant's total daily protein (1 g.kg-1.d-1) and energy requirement (1.5 x REE/BMR).
The protein is supplied either as the reference amino acid mixture or as a combination of the reference amino acid mixture and the test proteins. The amount of each test protein provided at each level of selected IAA (Indispensable Amino Acid) intake should be calculated based on the concentration from all sources.
Indicator AA (Amino Acid), phenylalanine is provided at 30 mg.kg-1.d -1 in all study diets (from food protein and isotope). The amount of phenylalanine provided from crystalline amino acid should be deducted depending on the natural phenylalanine content in the test protein.
The non-protein energy in the test diets is provided through a flavored sugar-oil drink and protein-free wheat starch cookies.
The reference amino acid mixture, non-labelled crystalline phenylalanine, tyrosine, and selected IAA are added and mixed with the sugar-oil drink before administering the hourly mini-meals. The test proteins are separately administered to the participants with each mini-meal.
Breath samples are collected before starting the first mini meal, at baseline (before the tracer protocol; a stable fed state in breath 13CO2 background abundance occurs after 4 hourly mini-meals) and every 15-min during isotopic steady state (approximately 2.5 h after starting the isotope). Three breath samples should be collected in 10 mL non-silicon-coated tubes using a collection mechanism that permits the removal of dead-space air at each time point. When breath collection coincides with an hourly meal, the breath sample should be collected first, followed by the meal. Then, all breath samples are stored at room temperature, pending analysis.
Enrichment of 13C in breath is analyzed by continuous flow isotope ratio mass spectrometer. The 13CO2 enrichment in the breath samples due to isotopic administration during the fed state is expressed as atom % excess (APE) over baseline. Then, the fraction of 13CO2 (F13CO2) from the tracer phenylalanine oxidation in relation to the amount administered is calculated.
The reference and test IAAO response slopes are calculated from F13CO2 measurements and the respective IAA intakes using a linear mixed effect regression mode, with a common origin of F13CO2 response at base test IAA intake. The metabolic availability (MA) of test amino acid in the test meal is determined by the slope-ratio method using the following equation:
MA (%) = (Test protein slope × 100)/ Reference slope
- Conditions
- Healthy Women of Child Bearing Potential
- Being tested
- Metabolic availability of methionine in mung beans
- Keywords
- Metabolic Availability, Methionine, IAAO, Mung beans
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metabolic availability of methionine in mung beansDietary supplement
Each participant will randomly receive 7 different levels of methionine provided as free amino acids and cooked mung beans.
| Study group | Role | What they receive |
|---|---|---|
| Methionine metabolic availability in mung beans | Experimental | Participants will be seen initially for pre-study assessment. They will then be studied for up to 7 times.
The participants will be expected to participate in 7 different sets of experiments which will take 2 to 3 months. Each set of experiment consists of a 3 day period. During the first 2 days (Adaptation Days) you will be expected to consume 4 meals per day consisting of a protein liquid drink and protein free-cookies and/or cooked mung bean, which will be provided by the investigators. Receives: Dietary Supplement: Metabolic availability of methionine in mung beans |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic availability of methionine in mung beans
Protein quality of mung beans measured as metabolic availability using the IAAO method
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2023
- Study startApr 2025 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Women of Child Bearing PotentialStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Food and Nutrition Research Institute, Philippines
- Sponsor type
- Other government
- Collaborators
- International Atomic Energy Agency, Mahidol University
- Responsible party
- Principal investigator, Johanne B. Guilaran, Food and Nutrition Research Institute, Philippines
- Investigators
- Johanne B Guilaran, Bachelor's, Principal investigator, Department of Science and Technology - Food and Nutrition Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06184984
- Sponsor's protocol ID
- FIERC-2024-030
- Status last verified
- Oct 2024
- First submitted
- 14 Dec 2023
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Availability of Methionine in Monggo Meal Among Women of Reproductive Age Using Indicator Amino Acid Oxidation (IAAO)
- ClinicalTrials.gov ID
- NCT06184984
- Acronym / sponsor ID
- FIERC-2024-030
- Conditions
- Healthy Women of Child Bearing Potential
- Keywords
- Metabolic Availability, Methionine, IAAO, Mung beans
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Food and Nutrition Research Institute, PhilippinesOther government
- Collaborators
- International Atomic Energy Agency, Mahidol University
- Study start
- Apr 2025 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 29 Dec 2023 (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 this study is to determine the protein quality of Philippine mung beans. The main objective of this study is to determine the metabolic availability of methionine in mung beans that the body can use. We will test the mung beans by studying them after cooking them as sauté.
This research is being done in order to bridge the gap between knowledge of protein requirement and the amount of food needed to meet that requirement. Results from this study will be important for recommendations guiding food choices of mung beans as a major protein source in the diet.
Each study participant will be part of seven (7) different experimental diets, and randomly assigned to one of the diets every time. Four (4) reference diets would be based on egg protein composition, and three (3) test diets will have protein from cooked mung beans.
Each experimental diet will be studied over 3 days: 2 adaptation days and 1 study day. The meals during the 2-day adaptation period would be consumed at home. On the study day, following a 10 to 12-h overnight fast, the study participants will come to the research unit at the Department of Science - Food and Nutrition Research Institute (DOST-FNRI), Gen. Santos Ave., Bicutan, Taguig City, Philippines, for a period of 8 to 9 hours and consume the diets as 9 hourly meals.
Detailed description
The pre-study assessments will include the measurement of Basal Metabolic Rate (BMR) / Resting Energy Expenditure (REE) by open-circuit indirect calorimetry, and body composition (fat and fat-free mass) by deuterium oxide dilution technique.
The study protocol is a 3-day experimental protocol (2 days of adaptation plus 1 study day), with an interval of ≥1 week to ensure complete tracer washout.
Each participant is adapted to the test diets for two days to provide them with adequate energy and protein (isonitrogenous diet), and to stabilize their metabolic pool. The energy during the adaptation period is provided at resting energy expenditure (REE/BMR) x 1.7 and protein 1.0 g.kg-1.d-1. During this period, each participant will be expected to consume 4 meals per day consisting of a protein liquid drink and protein free-cookies and/or cooked mung bean meal, which the investigators will provide.
On the study day, after a 10-12 h overnight fast, the participants will come to the research unit for 8-9 h, and receive 9 isonitrogenous, isocaloric hourly meals, each representing one-tenth of the participant's total daily protein (1 g.kg-1.d-1) and energy requirement (1.5 x REE/BMR).
The protein is supplied either as the reference amino acid mixture or as a combination of the reference amino acid mixture and the test proteins. The amount of each test protein provided at each level of selected IAA (Indispensable Amino Acid) intake should be calculated based on the concentration from all sources.
Indicator AA (Amino Acid), phenylalanine is provided at 30 mg.kg-1.d -1 in all study diets (from food protein and isotope). The amount of phenylalanine provided from crystalline amino acid should be deducted depending on the natural phenylalanine content in the test protein.
The non-protein energy in the test diets is provided through a flavored sugar-oil drink and protein-free wheat starch cookies.
The reference amino acid mixture, non-labelled crystalline phenylalanine, tyrosine, and selected IAA are added and mixed with the sugar-oil drink before administering the hourly mini-meals. The test proteins are separately administered to the participants with each mini-meal.
Breath samples are collected before starting the first mini meal, at baseline (before the tracer protocol; a stable fed state in breath 13CO2 background abundance occurs after 4 hourly mini-meals) and every 15-min during isotopic steady state (approximately 2.5 h after starting the isotope). Three breath samples should be collected in 10 mL non-silicon-coated tubes using a collection mechanism that permits the removal of dead-space air at each time point. When breath collection coincides with an hourly meal, the breath sample should be collected first, followed by the meal. Then, all breath samples are stored at room temperature, pending analysis.
Enrichment of 13C in breath is analyzed by continuous flow isotope ratio mass spectrometer. The 13CO2 enrichment in the breath samples due to isotopic administration during the fed state is expressed as atom % excess (APE) over baseline. Then, the fraction of 13CO2 (F13CO2) from the tracer phenylalanine oxidation in relation to the amount administered is calculated.
The reference and test IAAO response slopes are calculated from F13CO2 measurements and the respective IAA intakes using a linear mixed effect regression mode, with a common origin of F13CO2 response at base test IAA intake. The metabolic availability (MA) of test amino acid in the test meal is determined by the slope-ratio method using the following equation:
MA (%) = (Test protein slope × 100)/ Reference slope
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Methionine metabolic availability in mung beans | Experimental | Dietary Supplement: Metabolic availability of methionine in mung beansParticipants will be seen initially for pre-study assessment. They will then be studied for up to 7 times. The participants will be expected to participate in 7 different sets of experiments which will take 2 to 3 months. Each set of experiment consists of a 3 day period. During the first 2 days (Adaptation Days) you will be expected to consume 4 meals per day consisting of a protein liquid drink and protein free-cookies and/or cooked mung bean, which will be provided by the investigators. |
Who may qualify
- Ages
- 19 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Non-pregnant
- Non-lactating
- Stable body weight
- Healthy, with no known clinical condition that would affect protein or AA metabolism, e.g. Diabetes
- Not on any medications that could affect protein or amino acid metabolism e.g. steroids.
Key exclusion criteria (3 listed)
- Unwillingness to participate or unable to tolerate the diet
- Recent history of weight loss within the last 3 months or on a weight-reducing diet
- Inability to tolerate study diets (e.g. Allergy to ingredients)
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 |
|---|---|---|
| Metabolic availability of methionine in mung beansEach participant will randomly receive 7 different levels of methionine provided as free amino acids and cooked mung beans. | Dietary supplement | Methionine metabolic availability in mung beans |
Primary outcome
Metabolic availability of methionine in mung beans
Time frame: 2 years
Protein quality of mung beans measured as metabolic availability using the IAAO method
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Johanne B Guilaran, Bachelor's principal investigator
Department of Science and Technology - Food and Nutrition Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metabolic availability of methionine in mung beans in people with Healthy Women of Child Bearing Potential, run by Food and Nutrition Research Institute, Philippines at 1 site in Philippines.
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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 13 Feb 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 Philippines. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Johanne B Guilaran, Bachelor's ((63) 02 8837-8113 ext. 307, yuyanbguilaran@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabolic availability of methionine in mung beans (time frame: 2 years). 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 13 Feb 2025.