Satiety Evaluation of Mature Okra Flour-incorporated Biscuit (MOFB)

June 3, 2026 updated by: Tan Chee Yee, Universiti Putra Malaysia

Evaluating the Impact of Mature Okra Flour-Incorporated Biscuits (MOFB) on Perceived Satiety Through the Satiety Labeled Intensity Magnitude (SLIM) Scale and Metabolomic Approach

This study aims to evaluate whether eating biscuits made with mature okra flour can help young adults feel fuller (enhance satiety) and change certain blood markers compared to eating standard biscuits.

Mature okra is a nutrient-dense agricultural by-product that is often discarded due to its tough texture. For this study, mature okra pods are dried and ground into a flour, which is then used to replace 10% of the wheat flour in a custom biscuit formulation.

Participants will take part in a single-blind, randomised trial where they will consume either the okra-incorporated biscuits or the standard control biscuits on separate occasions. Researchers will measure participants' perceived fullness over 165 minutes using a visual rating scale. Blood samples will also be collected at specific intervals during this time to evaluate blood glucose levels, appetite-related hormones, and metabolic responses.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Okra is one of the top ten most consumed vegetable crops by Malaysians, with 1.7kg per capita consumption as reported by the Department of Statistic Malaysia in 2023. Among the total 65.6 thousand tonnes of output available, around 7.7% of the okra is turned into waste and partially fed to the livestock. Mature okra becomes unmarketable and turns into waste because it develops a tougher, more fibrous texture and a less desirable taste, unlike tender, immature okra, which is typically preferred for consumption. Studies in the literature found that mature okra also possesses comparable nutrient content or is even better than immature okra in certain aspects. Incorporation of agricultural waste, for instance, mature okra, into food products can offer significant health advantages besides reducing waste and also promotes a sustainable future, aligning with the objectives of Sustainable Development Goals (SDGs) goal No.12. Besides, transforming mature okra and other agricultural by-products into functional or value-added foods is an urge to address environmental and unsustainable use of natural resources. This study aims to evaluate the impact of mature okra flour-incorporated biscuits (MOFB) on perceived satiety and metabolomic responses. Mature okra flour will be prepared by dehydrating and grinding okra pods, then incorporated into biscuits at 10% substitution of wheat flour. This ratio of mature okra flour incorporation is pre-determined based on the previous phase study, as this ratio of incorporation results in a better nutritional profile and an acceptable sensorial score. Subsequently, thirty healthy young adults will participate in a single-blind, randomised trial comparing MOFB and control biscuits. Satiety will be assessed using the SLIM scale and blood glucose measurements over 165 minutes post-consumption. Blood samples will be collected for hormone and metabolomic analyses using ELISA, RIA, and Liquid Chromatography-Mass Spectrometry (LC-MS). The findings will help determine whether MOFB enhances satiety and alters metabolic profiles, supporting its potential as a functional food for appetite regulation.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Malaysia
    • Selangor
      • Serdang, Selangor, Malaysia, 43400
        • Recruiting
        • Faculty of Medicine and Health Sciences, Universiti Putra Malaysia (UPM)
        • Contact:
        • Principal Investigator:
          • Mohd Redzwan Sabran, PhD
        • Sub-Investigator:
          • Chee Yee Tan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Young adults aged between 18 and 39 years.
  • Normal Body Mass Index (BMI).

Exclusion Criteria:

  • Smokers.
  • Pregnant or lactating women.
  • Individuals with daily medication prescriptions for chronic metabolic conditions, cardiovascular management, or hormonal regulation.

  • Use of daily medications/supplements that influence appetite regulation, metabolic signalling, or systemic metabolomic profiles, including:

    1. Hormonal contraceptives, glucocorticoids, and oral/injectable anti-obesity medications (e.g., GLP-1 agonists).
    2. Antihypertensives and lipid-lowering agents (statins).
    3. Chronic Nonsteroidal Anti-Inflammatory Drugs (NSAIDs).
    4. Daily fibre supplements.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Mature Okra Flour-incorporated Biscuit (MOFB) Group
Young adult participants assigned to this group will consume the functional biscuit formulation incorporated with mature okra flour. Perceived satiety, metabolomic profiles, and appetite signalling will be assessed post-ingestion.
Other: Mature Okra Flour-incorporated Biscuit (MOFB)
Standard biscuit formulation manufactured where 10% of the wheat flour is substituted with mature okra flour, designed to enhance the nutritional profile while maintaining acceptable sensory scores.
Active Comparator: Control Biscuit Group
Young adult participants assigned to this group will consume the standard control biscuit formulation made with 100% wheat flour. Perceived satiety, metabolomic profiles, and appetite signalling will be assessed post-ingestion.
Other: Control Biscuit
Standard biscuit formulation manufactured using 100% wheat flour, designed to match the sensory profile and appearance of the experimental biscuit without the inclusion of mature okra flour.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Satiety Response
Time Frame: Baseline (0 minutes) and post-consumption at 15, 45, 75, 105, 135, and 165 minutes
The satiety response after biscuit consumption will be determined by the Satiety Labeled Intensity Magnitude (SLIM) scale. The SLIM scale consists of a 100mm vertical line with labelled phrases to indicate satiety: "greatest imaginable fullness", "extremely full", "very full", "moderately full", "slightly full", "neither hungry nor full", "slightly hungry", "moderately hungry", "very hungry", and "extremely hungry", and "greatest imaginable hunger". The first satiety survey is filled before breakfast (time 0), and the remaining surveys at 15, 45, 75, 105, 135 and 165 min later.
Baseline (0 minutes) and post-consumption at 15, 45, 75, 105, 135, and 165 minutes
Change in Plasma Insulin Concentration
Time Frame: Fasting state (0 minutes), 75 minutes, and 165 minutes post-consumption
Plasma concentration of insulin will be measured using an enzyme-linked immunosorbent assay (ELISA) kit. This metric evaluates metabolic responses to the biscuit interventions.
Fasting state (0 minutes), 75 minutes, and 165 minutes post-consumption
Change in Active Glucagon-Like Peptide-1 (GLP-1) Concentration
Time Frame: Fasting state (0 minutes), 75 minutes, and 165 minutes post-consumption
Plasma concentration of active GLP-1 will be measured using an enzyme-linked immunosorbent assay (ELISA) kit. This metric evaluates anorexigenic hormone responses to the biscuit interventions.
Fasting state (0 minutes), 75 minutes, and 165 minutes post-consumption
Change in Plasma Peptide YY (PYY3-36) Concentration
Time Frame: Fasting state (0 minutes), 75 minutes, and 165 minutes post-consumption
Plasma concentration of PYY3-36 will be measured using an enzyme-linked immunosorbent assay (ELISA) kit. This metric evaluates anorexigenic hormone responses to the biscuit interventions.
Fasting state (0 minutes), 75 minutes, and 165 minutes post-consumption
Change in Plasma Cholecystokinin (CCK) Concentration
Time Frame: Fasting state (0 minutes), 75 minutes, and 165 minutes post-consumption
Plasma concentration of CCK will be determined using a radioimmunoassay (RIA) kit. This metric evaluates anorexigenic hormone responses to the biscuit interventions.
Fasting state (0 minutes), 75 minutes, and 165 minutes post-consumption
Change in Active Ghrelin Concentration
Time Frame: Fasting state (0 minutes), 75 minutes, and 165 minutes post-consumption
Plasma concentration of active ghrelin will be measured using an enzyme-linked immunosorbent assay (ELISA) kit. This metric evaluates orexigenic hormone responses to the biscuit interventions.
Fasting state (0 minutes), 75 minutes, and 165 minutes post-consumption
Changes in Metabolite Profiles
Time Frame: Fasting state (0 minutes) and 165 minutes post-consumption
For metabolomic analysis, the blood samples will be taken in the fasting state (0 min) and after the last satiety survey (165 min). Metabolites will be quantified by Liquid Chromatography-Mass Spectrometry (LC-MS) analysis, and the serum samples will be prepared according to In Vitro Diagnostics Research (IVDr) standard operating procedures.
Fasting state (0 minutes) and 165 minutes post-consumption

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Blood Glucose Response
Time Frame: Baseline (0 minutes) and post-consumption at 15, 45, 75, 105, 135, and 165 minutes
The capillary blood glucose will be measured using the finger-prick method during the fasting state (time 0), and at 15, 45, 75, 105, 135 and 165 min later.
Baseline (0 minutes) and post-consumption at 15, 45, 75, 105, 135, and 165 minutes
Ad Libitum Energy Intake at a Subsequent Meal
Time Frame: At the end of the satiety evaluation session (165 minutes post-biscuit consumption)
Following the 165-minute satiety evaluation session, participants will be served an ad libitum meal consisting of fried rice and requested to consume as much as they want until comfortably full. The weight of the food consumed will be calculated by subtracting the remaining food weight from the initial served weight using a digital weighing scale (accurate to 1.0 g). Total energy intake will be calculated by multiplying the weight of the food consumed by the specific caloric content of the fried rice (expressed in kilocalories).
At the end of the satiety evaluation session (165 minutes post-biscuit consumption)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universiti Putra Malaysia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Mohd Redzwan Sabran, PhD, Universiti Putra Malaysia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 15, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 25, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 25, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 28, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 3, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 8, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • JKEUPM-2025-1085
  • GP-IPS/2024/9813100 (Other Grant/Funding Number: Universiti Putra Malaysia)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be publicly shared to protect participant confidentiality in accordance with institutional ethics committee guidelines. However, aggregated study data and final statistical outcomes will be made available upon reasonable request to the corresponding author.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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