Satiety Evaluation of Mature Okra Flour-incorporated Biscuit

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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.
• Другое 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.

Первичные конечные точки

• Satiety Response [Срок оценки: Baseline (0 minutes) and post-consumption at 15, 45, 75, 105, 135, and 165 minutes]
• Change in Plasma Insulin Concentration [Срок оценки: Fasting state (0 minutes), 75 minutes, and 165 minutes post-consumption]
• Change in Active Glucagon-Like Peptide-1 (GLP-1) Concentration [Срок оценки: Fasting state (0 minutes), 75 minutes, and 165 minutes post-consumption]
• Change in Plasma Peptide YY (PYY3-36) Concentration [Срок оценки: Fasting state (0 minutes), 75 minutes, and 165 minutes post-consumption]
• Change in Plasma Cholecystokinin (CCK) Concentration [Срок оценки: Fasting state (0 minutes), 75 minutes, and 165 minutes post-consumption]
• Change in Active Ghrelin Concentration [Срок оценки: Fasting state (0 minutes), 75 minutes, and 165 minutes post-consumption]
• Changes in Metabolite Profiles [Срок оценки: Fasting state (0 minutes) and 165 minutes post-consumption]

Вторичные конечные точки (2)

• Blood Glucose Response [Срок оценки: Baseline (0 minutes) and post-consumption at 15, 45, 75, 105, 135, and 165 minutes]
• Ad Libitum Energy Intake at a Subsequent Meal [Срок оценки: At the end of the satiety evaluation session (165 minutes post-biscuit consumption)]

Критерии участия

Критерии включения

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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Другое

Центры проведения

Малайзия · 1 центр

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

Идентификаторы

NCT: NCT07631663 · JKEUPM-2025-1085 · GP-IPS/2024/9813100

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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