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NCT Number: NCT07631663

Satiety Evaluation of Mature Okra Flour-incorporated Biscuit

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.

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Key information

Age range

18 year–39 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine and Health Sciences, Universiti Putra Malaysia (UPM)

Serdang, Selangor, 43400, Malaysia

Location status: Recruiting

Location contact

Chee Yee Tan

CONTACT

[email protected]

+60134904250

Chee Yee Tan

SUB_INVESTIGATOR

Mohd Redzwan Sabran, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mature Okra Flour-incorporated Biscuit (MOFB)

Other

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.

Control biscuit

Other

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Secondary outcomes

  1. 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.

  2. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Chee Yee Tan

CONTACT

[email protected]

+60134904250

Mohd Redzwan Sabran, PhD

CONTACT

[email protected]

+60397692766

Sponsors and collaborators

Lead sponsor

Universiti Putra Malaysia

Other

Registry information

Official study title

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

Acronym: MOFB

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 8, 2026
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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