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Metabolic Availability of Methionine in Tempeh Chips Among Reproductive-age Women Using Indicator Amino Acid Oxidation (IAAO) Method

Study acronym: IAAO
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 5 months later Oct 15, 2026 → Mar 15, 2027
See other at-risk trials from National University of Malaysia

Record History

  1. Notable Recruitment openedv3 Show 4 more changesShow less
    • Start date: Jun 20, 2026 to Oct 20, 2026
    • Primary completion pushed from Oct 15, 2026 to Mar 15, 2027
    • Study completion pushed from Oct 20, 2026 to May 20, 2027
    • Site details revised
  2. Notable Start date: Dec 20, 2025 to Jun 20, 2026
    • Primary completion date: Jun 15, 2026 to Oct 15, 2026
    • Study completion date: Aug 15, 2026 to Oct 20, 2026
    v2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07251842
Lead Sponsor National University of Malaysia
Collaborators: International Atomic Energy Agency
Conditions
(from sponsor)
Healthy Women of Child Bearing Potential
Enrollment 6 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov