Healthy Women of Child Bearing PotentialIAAONCT07251842
Metabolic Availability of Methionine in Tempeh Chips Among Reproductive-age Women Using Indicator Amino Acid Oxidation (IAAO) Method
A study testing dietary intakes and Dietary intake in people with Healthy Women of Child Bearing Potential, run by National University of Malaysia at 1 site in Malaysia.
Trial summary
The goal of this study is to determine the protein quality of soybean tempeh in the form of chips. The main objective of this study is to determine how much methionine in tempeh can be used by reproductive-age women using the stable isotope method. The tempeh will be studied in the form of chips. Read more about this study
- Who is it for?
- Ages 19 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Women of Child Bearing Potential
- What is being tested?
- dietary intakes and Dietary intake
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteMalaysia
- Study dates
- 20 Oct 2026to 20 May 2027
- 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 19 to 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Universiti Kebangsaan Malaysia Kuala Lumpur campus female students and staffs aged 19 - 30 years old
- Malaysian
- Have consistent weight in the past 6 months
- Have a normal body fat percentage (20% - 29.9%)
Who cannot join
- Pregnant women
- Lactating women
- Reported serious medical or surgical ailments 3 months prior to start of the study
- On dietary or nutrient supplements or who had taken antibiotics 4 weeks before the initiation of the study
- Smoking
- Allergy to soybean
- Excessively high protein intake in the past 6 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Malaysia1 site, 1 recruiting
- Recruiting
Universiti Kebangsaan Malaysia Kampus Kuala Lumpur
Kuala Lumpur, 50300
About this study
Official title: Understanding the Metabolic Availability of Methionine in High Calcium Tempeh (TempeCalTM) Chips Among Reproductive-Age Women by Using the Stable Isotope Technique
The goal of this study is to determine the protein quality of soybean tempeh in the form of chips. The main objective of this study is to determine how much methionine in tempeh can be used by reproductive-age women using the stable isotope method. The tempeh will be studied in the form of chips.
This research is being done to bridge the gap between the knowledge of protein requirements and the amount of food needed to meet those requirements. Results from this study will be important to confirm the protein quality of tempeh and thus provide a new alternative good protein source for humans, especially vegetarians and those with low socioeconomic status.
Each participant will undergo seven experimental trials randomly. During four experimental trials, methionine intake will be obtained from a crystalline amino acid mixture, and during another three experimental trials, it will be obtained from tempeh chips. Each experimental trial will take three days, consisting of two adaptation days and one study day. During the two adaptation days, four equal meals per day will be consumed by the participants at their own place. On the study day, participants will need to come to the research unit of the National University of Malaysia, Kuala Lumpur campus, to consume nine hourly meals. In addition, during the study day, participants will also need to have their breath samples collected, their expired carbon dioxide rate measured, and consume a stable isotope.
Read the detailed description
For the pre-study assessment, participants will be required to measure their body weight, height, and resting energy expenditure (REE) using indirect calorimetry.
The study protocol is a 3-day experimental protocol consisting of 2 adaptation days and 1 indicator amino acid oxidation (IAAO) study day. For each 3-day experimental protocol, participants will be provided with either a reference diet for 3 days or a tempeh diet for 3 days. To begin another 3-day experimental protocol for the same participant, at least a 1-week interval will be required to ensure complete washout of the tracer.
During each adaptation period, every participant will be given 4 equal meals per day (breakfast, lunch, dinner, and snack) that fulfill 100% of their daily energy and protein requirements (Energy requirement = Resting Energy Expenditure (REE) × 1.7; Protein requirement = 1.0 g/kg/day × body weight). Meals provided will include a protein-free formula (required), protein-free butterscotch cookies (required), a crystalline amino acid mixture, or a combination of the crystalline amino acid mixture with tempeh chips. The meals should be finished by participants within 15 minutes. A daily multivitamin supplement and a 500 mg choline supplement will also be provided. In addition to plain water, only one cup of tea or coffee without sugar or cream is allowed during the adaptation days.
During the IAAO study period, after an overnight fast of 12 hours, participants will attend the metabolic laboratory at Kolej Tun Syed Nasir (KTSN) for 8 hours. A total of 9 isonitrogenous and isocaloric hourly meals will be provided, with each meal contributing 1/10 of the total energy requirement (REE × 1.5) and protein requirement (1.0 g/kg/day). Meals will consist of a protein-free formula (required), protein-free butterscotch cookies (required), and either a crystalline amino acid mixture or a combination of the crystalline amino acid mixture with tempeh chips. Each meal should be consumed within 15 minutes. The total meals provided will meet 90% of the participants' energy and protein requirements. During the experimental day, a daily multivitamin supplement and 500 mg of choline will also be provided.
During the first to fourth meals, participants will only be required to consume the provided meals. Starting from the fifth meal, participants will receive a constant oral isotope incorporation. Phenylalanine, an indispensable amino acid whose final metabolism produces carbon dioxide, will be used as the tracer to measure oxidation. In addition, NaH13CO3 (¹³C-sodium bicarbonate) will be administered as a priming dose to allow 13CO2(carbon-13 labeled CO₂) in the breath to reach a plateau within 2-3 hours. A dose of 0.176 mg/kg of NaH13CO3 and 0.66 mg/kg of L-[1-13C]phenylalanine will be given as the priming isotope during the fifth meal. From the fifth meal until the last meal, 1.2 mg/kg of L-[1-13C]phenylalanine will be provided continuously. The amount of phenylalanine provided as the tracer (excluding the priming isotope) will be subtracted from the dietary provision to maintain a total phenylalanine intake of 30 mg/kg/day. A total of 40 mg/kg/day (160% of the total aromatic amino acid requirement) of tyrosine will also be provided to ensure that no labeled phenylalanine is hydroxylated to meet the tyrosine requirement. After the fifth meal, the expired carbon dioxide production rate (VCO2) will be measured using indirect calorimetry for 15 minutes.
For breath sample collection, samples will be collected every 15 minutes before the tracer protocol is initiated (i.e., before the fifth meal) and every 15 minutes after isotopic steady state is reached (approximately 2.5 hours after isotope administration) until the end of the study. Additional breath samples will be collected 30 minutes after the end of the study. Each breath sample will be collected in triplicate using 10 mL non-silicon-coated tubes. The enrichment of 13CO2 in the breath will be analyzed using a continuous-flow isotope ratio mass spectrometer and expressed as atom percent excess (APE) over baseline. The fraction of 13CO2 (F13CO2) from L-[1-13C]phenylalanine oxidation relative to the amount administered will be calculated.
Using a linear mixed-effects regression model, the reference and test IAAO response slopes will be generated from F13CO2 measurements and their corresponding methionine intakes, with a common origin of the F13CO2 response at the base methionine intake. The metabolic availability (MA) of methionine in the test protein will be determined by the slope-ratio method using the following equation:
MA (%) = (Test protein / Reference protein) × 100.
- Conditions
- Healthy Women of Child Bearing Potential
- Being tested
- dietary intakes, Dietary intake
- Keywords
- IAAO, Metabolic availability, tempeh
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dietary intakesOther
Also called crystalline amino acid mixture
Four levels of methionine intake provided via a crystalline amino acid mixture.
Dietary intakeOther
Also called tempeh chips
Three levels of methionine intake derived from tempeh chips.
| Study group | Role | What they receive |
|---|---|---|
| metabolic availability of methionine in tempeh chips | Experimental | Participants will undergo a pre-study assessment and will then complete up to seven experimental sessions over approximately 1.5-2 months.
Each experimental set lasts 3 days. During the first 2 days (Adaptation Days), participants will consume four meals per day consisting of a protein liquid drink and protein-free cookies and/or tempeh chips provided by the investigators. Receives: Other: dietary intakes; Other: Dietary intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic availability of methionine in tempeh chips
Using the Indicator Amino Acid Oxidation (IAAO) method to determine the MA of methionine in tempeh that is prepared in the chips form
Measured: From enrollment to the end of treatment at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study start20 Oct 2026 (estimated)
- Primary completion15 Mar 2027 (estimated)
- Study completion20 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Each subject will randomly receive 4 levels of methionine provided as free amino acids, 3 levels of methionine provided as tempeh chips for a total of 7 studies x 3 days per study.
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University of Malaysia
- Sponsor type
- University, hospital or other
- Collaborators
- International Atomic Energy Agency
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07251842
- Sponsor's protocol ID
- FRGS/1/2024/SKK06/UKM/02/3
- Acronym
- IAAO
- Status last verified
- Aug 2026
- First submitted
- 17 Nov 2025
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rafii M, Pencharz PB, Boileau K, Ball RO, Tomlinson C, Elango R, Courtney-Martin G. Metabolic Availability of Methionine Assessed Using Indicator Amino Acid Oxidation Method, Is Greater when Cooked Lentils and Steamed Rice Are Combined in the Diet of Healthy Young Men. J Nutr. 2022 Jun 9;152(6):1467-1475. doi: 10.1093/jn/nxac049.
PubMed 35218191
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding the Metabolic Availability of Methionine in High Calcium Tempeh (TempeCalTM) Chips Among Reproductive-Age Women by Using the Stable Isotope Technique
- ClinicalTrials.gov ID
- NCT07251842
- Acronym / sponsor ID
- IAAO / FRGS/1/2024/SKK06/UKM/02/3
- Conditions
- Healthy Women of Child Bearing Potential
- Keywords
- IAAO, Metabolic availability, tempeh
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- National University of MalaysiaUniversity, hospital or other
- Collaborators
- International Atomic Energy Agency
- Study start
- 20 Oct 2026 (estimated)
- Primary completion
- 15 Mar 2027 (estimated)
- Study completion
- 20 May 2027 (estimated)
- First posted
- 26 Nov 2025 (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 soybean tempeh in the form of chips. The main objective of this study is to determine how much methionine in tempeh can be used by reproductive-age women using the stable isotope method. The tempeh will be studied in the form of chips.
This research is being done to bridge the gap between the knowledge of protein requirements and the amount of food needed to meet those requirements. Results from this study will be important to confirm the protein quality of tempeh and thus provide a new alternative good protein source for humans, especially vegetarians and those with low socioeconomic status.
Each participant will undergo seven experimental trials randomly. During four experimental trials, methionine intake will be obtained from a crystalline amino acid mixture, and during another three experimental trials, it will be obtained from tempeh chips. Each experimental trial will take three days, consisting of two adaptation days and one study day. During the two adaptation days, four equal meals per day will be consumed by the participants at their own place. On the study day, participants will need to come to the research unit of the National University of Malaysia, Kuala Lumpur campus, to consume nine hourly meals. In addition, during the study day, participants will also need to have their breath samples collected, their expired carbon dioxide rate measured, and consume a stable isotope.
Detailed description
For the pre-study assessment, participants will be required to measure their body weight, height, and resting energy expenditure (REE) using indirect calorimetry.
The study protocol is a 3-day experimental protocol consisting of 2 adaptation days and 1 indicator amino acid oxidation (IAAO) study day. For each 3-day experimental protocol, participants will be provided with either a reference diet for 3 days or a tempeh diet for 3 days. To begin another 3-day experimental protocol for the same participant, at least a 1-week interval will be required to ensure complete washout of the tracer.
During each adaptation period, every participant will be given 4 equal meals per day (breakfast, lunch, dinner, and snack) that fulfill 100% of their daily energy and protein requirements (Energy requirement = Resting Energy Expenditure (REE) × 1.7; Protein requirement = 1.0 g/kg/day × body weight). Meals provided will include a protein-free formula (required), protein-free butterscotch cookies (required), a crystalline amino acid mixture, or a combination of the crystalline amino acid mixture with tempeh chips. The meals should be finished by participants within 15 minutes. A daily multivitamin supplement and a 500 mg choline supplement will also be provided. In addition to plain water, only one cup of tea or coffee without sugar or cream is allowed during the adaptation days.
During the IAAO study period, after an overnight fast of 12 hours, participants will attend the metabolic laboratory at Kolej Tun Syed Nasir (KTSN) for 8 hours. A total of 9 isonitrogenous and isocaloric hourly meals will be provided, with each meal contributing 1/10 of the total energy requirement (REE × 1.5) and protein requirement (1.0 g/kg/day). Meals will consist of a protein-free formula (required), protein-free butterscotch cookies (required), and either a crystalline amino acid mixture or a combination of the crystalline amino acid mixture with tempeh chips. Each meal should be consumed within 15 minutes. The total meals provided will meet 90% of the participants' energy and protein requirements. During the experimental day, a daily multivitamin supplement and 500 mg of choline will also be provided.
During the first to fourth meals, participants will only be required to consume the provided meals. Starting from the fifth meal, participants will receive a constant oral isotope incorporation. Phenylalanine, an indispensable amino acid whose final metabolism produces carbon dioxide, will be used as the tracer to measure oxidation. In addition, NaH13CO3 (¹³C-sodium bicarbonate) will be administered as a priming dose to allow 13CO2(carbon-13 labeled CO₂) in the breath to reach a plateau within 2-3 hours. A dose of 0.176 mg/kg of NaH13CO3 and 0.66 mg/kg of L-[1-13C]phenylalanine will be given as the priming isotope during the fifth meal. From the fifth meal until the last meal, 1.2 mg/kg of L-[1-13C]phenylalanine will be provided continuously. The amount of phenylalanine provided as the tracer (excluding the priming isotope) will be subtracted from the dietary provision to maintain a total phenylalanine intake of 30 mg/kg/day. A total of 40 mg/kg/day (160% of the total aromatic amino acid requirement) of tyrosine will also be provided to ensure that no labeled phenylalanine is hydroxylated to meet the tyrosine requirement. After the fifth meal, the expired carbon dioxide production rate (VCO2) will be measured using indirect calorimetry for 15 minutes.
For breath sample collection, samples will be collected every 15 minutes before the tracer protocol is initiated (i.e., before the fifth meal) and every 15 minutes after isotopic steady state is reached (approximately 2.5 hours after isotope administration) until the end of the study. Additional breath samples will be collected 30 minutes after the end of the study. Each breath sample will be collected in triplicate using 10 mL non-silicon-coated tubes. The enrichment of 13CO2 in the breath will be analyzed using a continuous-flow isotope ratio mass spectrometer and expressed as atom percent excess (APE) over baseline. The fraction of 13CO2 (F13CO2) from L-[1-13C]phenylalanine oxidation relative to the amount administered will be calculated.
Using a linear mixed-effects regression model, the reference and test IAAO response slopes will be generated from F13CO2 measurements and their corresponding methionine intakes, with a common origin of the F13CO2 response at the base methionine intake. The metabolic availability (MA) of methionine in the test protein will be determined by the slope-ratio method using the following equation:
MA (%) = (Test protein / Reference protein) × 100.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Each subject will randomly receive 4 levels of methionine provided as free amino acids, 3 levels of methionine provided as tempeh chips for a total of 7 studies x 3 days per study.
| Arm | Type | Receives |
|---|---|---|
| metabolic availability of methionine in tempeh chips | Experimental | Other: dietary intakes, Other: Dietary intakeParticipants will undergo a pre-study assessment and will then complete up to seven experimental sessions over approximately 1.5-2 months. Each experimental set lasts 3 days. During the first 2 days (Adaptation Days), participants will consume four meals per day consisting of a protein liquid drink and protein-free cookies and/or tempeh chips provided by the investigators. |
Who may qualify
- Ages
- 19 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Universiti Kebangsaan Malaysia Kuala Lumpur campus female students and staffs aged 19 - 30 years old
- Malaysian
- Have consistent weight in the past 6 months
- Have a normal body fat percentage (20% - 29.9%)
Key exclusion criteria (7 listed)
- Pregnant women
- Lactating women
- Reported serious medical or surgical ailments 3 months prior to start of the study
- On dietary or nutrient supplements or who had taken antibiotics 4 weeks before the initiation of the study
- Smoking
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 |
|---|---|---|
| dietary intakesAlso: crystalline amino acid mixtureFour levels of methionine intake provided via a crystalline amino acid mixture. | Other | metabolic availability of methionine in tempeh chips |
| Dietary intakeAlso: tempeh chipsThree levels of methionine intake derived from tempeh chips. | Other | metabolic availability of methionine in tempeh chips |
Primary outcome
Metabolic availability of methionine in tempeh chips
Time frame: From enrollment to the end of treatment at 8 weeks
Using the Indicator Amino Acid Oxidation (IAAO) method to determine the MA of methionine in tempeh that is prepared in the chips form
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 5 Aug 2026.
- Background: PubMed 35218191Rafii M, Pencharz PB, Boileau K, Ball RO, Tomlinson C, Elango R, Courtney-Martin G. Metabolic Availability of Methionine Assessed Using Indicator Amino Acid Oxidation Method, Is Greater when Cooked Lentils and Steamed Rice Are Combined in the Diet of Healthy Young Men. J Nutr. 2022 Jun 9;152(6):1467-1475. doi: 10.1093/jn/nxac049.
- Individual participant dataSharing planned: No
Related trials for Healthy Women of Child Bearing Potential
RecruitingPhase 2
PfSPZ-LARC2 Vaccine in Women of Child-bearing Potential (WOCBP) in Mali
Malaria (Plasmodium Falciparum)
Active, not recruitingPhase 2
Assessment of Safety, Immunogenicity and Efficacy of R21/Matrix-M1 Malaria Vaccine in Healthy WOCBP in Mali
Healthy Women of Child Bearing Potential
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dietary intakes and Dietary intake in people with Healthy Women of Child Bearing Potential, run by National University of Malaysia at 1 site in Malaysia.
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 4 inclusion and 7 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 5 Aug 2026. 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 Malaysia. 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 Hasnah Haron Associate Professor Ts. Dr. (+60133996594, hasnaharon@ukm.edu.my), 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 tempeh chips (time frame: From enrollment to the end of treatment at 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07251842, which also lists 1 linked publication.
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 5 Aug 2026.