- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07631663
Satiety Evaluation of Mature Okra Flour-incorporated Biscuit (MOFB)
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.
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Chee Yee Tan
- Telefonní číslo: +60134904250
- E-mail: cheeyee721@gmail.com
Studijní záloha kontaktů
- Jméno: Mohd Redzwan Sabran, PhD
- Telefonní číslo: +60397692766
- E-mail: mohdredzwan@upm.edu.my
Studijní místa
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Selangor
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Serdang, Selangor, Malajsie, 43400
- Nábor
- Faculty of Medicine and Health Sciences, Universiti Putra Malaysia (UPM)
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Kontakt:
- Chee Yee Tan
- Telefonní číslo: +60134904250
- E-mail: cheeyee721@gmail.com
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Vrchní vyšetřovatel:
- Mohd Redzwan Sabran, PhD
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Dílčí vyšetřovatel:
- Chee Yee Tan
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Jiný
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: 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.
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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.
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Aktivní komparátor: 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.
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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.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Satiety Response
Časové okno: Baseline (0 minutes) and post-consumption at 15, 45, 75, 105, 135, and 165 minutes
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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.
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Baseline (0 minutes) and post-consumption at 15, 45, 75, 105, 135, and 165 minutes
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Change in Plasma Insulin Concentration
Časové okno: Fasting state (0 minutes), 75 minutes, and 165 minutes post-consumption
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Plasma concentration of insulin will be measured using an enzyme-linked immunosorbent assay (ELISA) kit.
This metric evaluates metabolic responses to the biscuit interventions.
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Fasting state (0 minutes), 75 minutes, and 165 minutes post-consumption
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Change in Active Glucagon-Like Peptide-1 (GLP-1) Concentration
Časové okno: Fasting state (0 minutes), 75 minutes, and 165 minutes post-consumption
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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.
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Fasting state (0 minutes), 75 minutes, and 165 minutes post-consumption
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Change in Plasma Peptide YY (PYY3-36) Concentration
Časové okno: Fasting state (0 minutes), 75 minutes, and 165 minutes post-consumption
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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.
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Fasting state (0 minutes), 75 minutes, and 165 minutes post-consumption
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Change in Plasma Cholecystokinin (CCK) Concentration
Časové okno: Fasting state (0 minutes), 75 minutes, and 165 minutes post-consumption
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Plasma concentration of CCK will be determined using a radioimmunoassay (RIA) kit.
This metric evaluates anorexigenic hormone responses to the biscuit interventions.
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Fasting state (0 minutes), 75 minutes, and 165 minutes post-consumption
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Change in Active Ghrelin Concentration
Časové okno: Fasting state (0 minutes), 75 minutes, and 165 minutes post-consumption
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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.
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Fasting state (0 minutes), 75 minutes, and 165 minutes post-consumption
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Changes in Metabolite Profiles
Časové okno: Fasting state (0 minutes) and 165 minutes post-consumption
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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.
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Fasting state (0 minutes) and 165 minutes post-consumption
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Blood Glucose Response
Časové okno: Baseline (0 minutes) and post-consumption at 15, 45, 75, 105, 135, and 165 minutes
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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.
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Baseline (0 minutes) and post-consumption at 15, 45, 75, 105, 135, and 165 minutes
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Ad Libitum Energy Intake at a Subsequent Meal
Časové okno: At the end of the satiety evaluation session (165 minutes post-biscuit consumption)
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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).
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At the end of the satiety evaluation session (165 minutes post-biscuit consumption)
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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Studijní židle: Mohd Redzwan Sabran, PhD, Universiti Putra Malaysia
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další identifikační čísla studie
- JKEUPM-2025-1085
- GP-IPS/2024/9813100 (Jiné číslo grantu/financování: Universiti Putra Malaysia)
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