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RECRUITING
NCT07420023
NA

The Satiety Control Optimization by Nutritional Enhancement Study

Sponsor: University College Cork

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

24

Start Date

2025-08-18

Completion Date

2026-05

Last Updated

2026-02-19

Healthy Volunteers

Yes

Interventions

OTHER

Cereal-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