RecruitingNot ApplicableNCT07420023

The Satiety Control Optimization by Nutritional Enhancement Study

Characterization of the Impact of Dietary Fibre Interactions in Food Products on Postprandial Glycaemic Response, Satiety, and Microbiome Composition and Function


Sponsor

University College Cork

Enrollment

24 participants

Start Date

Aug 18, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

High-glycaemic foods contribute to elevated risk of obesity, type 2 diabetes, and cardiometabolic disease. Replacing digestible carbohydrates with dietary fibres is known to reduce postprandial glycaemic excursions, enhance satiety, and support beneficial microbial fermentation. However, limited evidence exists on how interactions between different isolated fibres within a processed food matrix may modulate these responses, particularly when such interactions could recreate structural features of intrinsic plant fibre networks that naturally restrict starch accessibility and alter fermentation dynamics. This randomized, single-blinded, placebo-controlled crossover trial will investigate how isolated dietary fibres, alone and in combination, influence metabolic and microbial responses when incorporated into a commonly consumed cereal-based food (scone). Overweight but otherwise healthy adults (BMI 25-\<30 kg/m²) will consume seven fibre-enriched scone formulations across two consecutive mornings per intervention phase. Outcomes include postprandial glycaemic response measured via continuous glucose monitoring (primary outcome), perceived satiety and energy intake, gastrointestinal symptoms, fermentation dynamics via breath hydrogen and methane, and gut microbiota composition assessed through 16S rRNA sequencing. This study will generate novel insights into potential synergistic interactions between isolated fibres within a food matrix and their consequences for glycaemic control, satiety, microbial fermentation, and community. Findings will inform next-generation food design strategies aimed at replicating complex intrinsic fibre structures to enhance the health impact of processed foods.


Eligibility

Min Age: 18 YearsMax Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether specific nutritional supplements or foods can improve feelings of fullness (satiety) and help manage weight in overweight but otherwise healthy adults. Participants will try different dietary interventions and researchers will measure hunger hormones, appetite, and metabolic markers. **You may be eligible if...** - You are 18 to 45 years old - Your BMI is between 25 and 30 (overweight range) - Your waist circumference is above 94 cm (men) or 80 cm (women) - Your body weight has been stable for the past 3 months - You are in generally good health **You may NOT be eligible if...** - You are obese (BMI 30 or above) or underweight - You have metabolic or hormonal conditions affecting weight - You are outside the age range Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERCereal-based food, Fiber-enriched scones

Scone supplemented with 4 to 20 grams of fibres, nicknamed (A, B, C, D, E, F, G)


Locations(1)

University College Cork

Cork, Ireland

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NCT07420023