The Satiety Control Optimization by Nutritional Enhancement Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-45
SponsorUniversity College Cork
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
Be willing and able to give written informed consent.
Be between 18 and 45 years of age.
Have a BMI of =25<30kg/m2(overweight).
Have a waist circumference of >94cm for a male, >80cm for a female (increased risk of metabolic syndrome).
Disqualifiers
Pregnant, lactating, or post-menopausal women, or women who are planning to become pregnant over the study period.
Have had antibiotic treatment within three months before baseline.
Are taking a medication that the investigator believes would interfere with the objectives of the study, pose a safety risk, or confound the interpretation of study results; to include anti-inflammatory drugs, H2 blockers, antacids, proton pump inhibitors, anti-hypertensive medications, corticosteroids, laxatives, enemas, antibiotics, anti-coagulants, and immunosuppressant medication. Participants should have a wash-out period of at least two weeks for each of these medications except for antibiotics, which should not have been taken in the previous three months. Participants taking proton pump inhibitors and medications for chronic conditions (e.g., anti-hypertensive medication) will be allowed into the study if the dose has been stable for at least two months before the study baseline visit.
Have a history or indication of drug and/or alcohol abuse at the time of enrolment.
Trial design
Design model
Crossover
Treatments tested in this trial
Cereal-based food, Fiber-enriched scones
Other interventionScone supplemented with 4 to 20 grams of fibres, nicknamed (A, B, C, D, E, F, G)
Treatment groups
24 Participants
are divided into 3 treatment groupsGroup A: AExperimental treatment 1 intervention
Group B: BExperimental treatment 1 intervention
Group C: CExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Impact on Postprandial Glycaemic Response
Change in interstitial glucose concentration following consumption of each interventional meal, measured using continuous glucose monitoring. The primary endpoint is the incremental area under the curve (iAUC) for glucose over 2 hours post-consumption between treatments.
Time frame
Measured continuously over each 2-day intervention phase, with readings recorded every 15 minutes, covering all seven scone interventions plus baseline across the 28-day study period.Secondary outcomes
1
Changes in participant-reported Perceived Satiety
Subjective feelings of hunger and fullness were assessed using a validated Satiety Labeled Intensity Magnitude (SLIM) visual analogue scale (VAS) ranging from -50 ("greatest imaginable hunger") to +50 ("greatest fullness"), administered before and after each intervention meal. Snack consumption, provided ad libitum, was also monitored as an objective proxy for satiety.
Time frame
Before and after each breakfast, lunch, and dinner, measurements were taken over the three days of baseline (days 1-3) and during each 2-day intervention phase for all seven scone interventions (days 5-6, 8-9, 12-13, 15-16, 19-20, 22-23, 26-27).2
Gastrointestinal Tolerance and Symptoms
Participant-reported GI symptoms (bloating, cramping, stool frequency and form, discomfort) collected via validated questionnaires, including the Bristol Stool Scale, to assess tolerance to fibre-enriched scones
Time frame
8 times total at baseline (day 3) and on the second day of each intervention phase (days 6, 9, 13, 16, 20, 23, 27)3
Bacterial Fermentation
Measurement of breath hydrogen and methane concentrations to assess colonic fermentation and transit of fibre, using a portable breath-analysis device
Time frame
Before and after each breakfast, lunch, and dinner, measurements were taken over the three days of baseline (days 1-3) and during each 2-day intervention phase for all seven scone interventions (days 5-6, 8-9, 12-13, 15-16, 19-20, 22-23, 26-27).4
Gut Microbiome Composition
Analysis of participant faecal samples using 16S rRNA gene sequencing to determine microbiota composition, diversity, and potential functional changes in response to individual or combined dietary fibres.
Time frame
8 times total a day after baseline (day 4) and on the day after each intervention phase (days 7, 10, 14, 17, 21, 24, 28).Sponsors and contacts
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Source ClinicalTrials.gov