Satiety Evaluation of Mature Okra Flour-incorporated Biscuit

NCT07631663 | Recruiting

• 2 other identifiers: JKEUPM-2025-1085GP-IPS/2024/9813100
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Young Adults; Appetite Regulation

Keywords

Satiety response; Blood glucose response; Hormonal change; Metabolomic analysis

Outcome Measures

Primary Outcomes (7)

• Satiety Response

  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

  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

  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

  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

  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

  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

  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 Outcomes (2)

• Blood Glucose Response

  Baseline (0 minutes) and post-consumption at 15, 45, 75, 105, 135, and 165 minutes

• Ad Libitum Energy Intake at a Subsequent Meal

  At the end of the satiety evaluation session (165 minutes post-biscuit consumption)

Study Arms (2)

Mature Okra Flour-incorporated Biscuit (MOFB) Group

EXPERIMENTAL

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)

Control Biscuit Group

ACTIVE COMPARATOR

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

Interventions

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.

Mature Okra Flour-incorporated Biscuit (MOFB) Group

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.

Control Biscuit Group

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universiti Putra Malaysia: lead

Study Sites (1)

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

Serdang, Selangor, 43400, Malaysia

RECRUITING

Study Officials

• Mohd Redzwan Sabran, PhD

  Universiti Putra Malaysia

  STUDY CHAIR

Central Study Contacts

Chee Yee Tan

CONTACT

+60134904250; cheeyee721@gmail.com

Mohd Redzwan Sabran, PhD

CONTACT

+60397692766; mohdredzwan@upm.edu.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD candidate

Model Details: Thirty volunteers will be recruited in Faculty of Medicine and Health Science, UPM for the single-blind satiety evaluation. Volunteers' habitual dietary behaviours and chronotypes will be assessed and considered prior to randomisation to ensure balanced group distribution. To balance the study groups, participants will be stratified based on their age, BMI, and psychometric profiles derived from the Three-Factor Eating Questionnaire-R18 (TFEQ-R18) and Morningness-Eveningness Questionnaire (MEQ). This process ensures that baseline traits are evenly distributed between the MOFB and control groups. By controlling for these biological and behavioural variables prior to randomisation, the study minimises confounding factors, ensuring that any observed differences in satiety are accurately attributed to the mature okra flour intervention. The volunteers will be assigned to two groups and follow two different breakfasts that include biscuits incorporated with okra flour and control biscuit.

Study Record Dates

• First Submitted: May 28, 2026
• First Posted: June 8, 2026
• Study Start: May 15, 2026
• Primary Completion: June 25, 2026
• Study Completion: June 25, 2026
• Last Updated: June 8, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)