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

NCT07251842 | Not Yet Recruiting

• 1 other identifier: FRGS/1/2024/SKK06/UKM/02/3
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Healthy Women of Child Bearing Potential

Keywords

IAAO; Metabolic availability; tempeh

Outcome Measures

Primary Outcomes (1)

• 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

  From enrollment to the end of treatment at 8 weeks

Study Arms (1)

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.

Other: dietary intakes; Other: Dietary intake

Interventions

dietary intakes OTHER

Four levels of methionine intake provided via a crystalline amino acid mixture.

Also known as: crystalline amino acid mixture

metabolic availability of methionine in tempeh chips

Dietary intake OTHER

Three levels of methionine intake derived from tempeh chips.

Also known as: tempeh chips

metabolic availability of methionine in tempeh chips

Eligibility Criteria

• Age: 19 Years - 30 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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%)

You may not qualify if:

• 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

Sponsors & Collaborators

• National University of Malaysia: lead
• International Atomic Energy Agency: collaborator

Study Sites (1)

Universiti Kebangsaan Malaysia Kampus Kuala Lumpur

Kuala Lumpur, 50300, Malaysia

Location

Related Publications (1)

• 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.

  PMID: 35218191 BACKGROUND

MeSH Terms

Interventions

Eating

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Digestive System Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Central Study Contacts

Hasnah Haron Associate Professor Ts. Dr.

CONTACT

+60133996594; hasnaharon@ukm.edu.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 26, 2025
• Study Start (Estimated): June 20, 2026
• Primary Completion (Estimated): October 15, 2026
• Study Completion (Estimated): October 20, 2026
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)