The Satiety Control Optimization by Nutritional Enhancement Study

NCT07420023 | Recruiting

• 1 other identifier: APC-189
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Metabolic Diseases, Type 2 Diabetes, Cardiovascular Disease

Keywords

Dietary fibers; metabolic diseases; blood glucose; satiety; fermentation; food matrix

Outcome Measures

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.

  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 (4)

• Changes in participant-reported Perceived Satiety

  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).

• Gastrointestinal Tolerance and Symptoms

  8 times total at baseline (day 3) and on the second day of each intervention phase (days 6, 9, 13, 16, 20, 23, 27)

• Bacterial Fermentation

  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).

• Gut Microbiome Composition

  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).

Study Arms (3)

A

EXPERIMENTAL

The order in which each participant receives the seven different scone recipes. D, C, E, A, F, B, G

Other: Cereal-based food, Fiber-enriched scones

B

EXPERIMENTAL

The order in which each participant receives the seven different scone recipes. C, D, G, B, A, F, E

Other: Cereal-based food, Fiber-enriched scones

C

EXPERIMENTAL

The order in which each participant receives the seven different scone recipes. E, F, A, G, D, C, B

Other: Cereal-based food, Fiber-enriched scones

Interventions

Cereal-based food, Fiber-enriched scones OTHER

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

A; B; C

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).
• Have had a stable body weight (\<5% change over the past three months).
• Be in general good health as determined by the investigator through interview and vital signs (blood pressure, pulse, temperature). Systolic blood pressure less than 160mm Hg and diastolic blood pressure less than 100 mm Hg (defined as Hypertension stage 2).
• Be willing to avoid consuming dietary supplements (at the discretion of the investigator), prebiotics, probiotics, or fibre-rich supplements within four weeks before the baseline visit, and until the end of the study.
• Be willing to avoid vigorous physical activities on the interventional days (defined as any physical activity that is planned to achieve a fitness goal).
• Be willing to consume the investigational food products and menu plan daily for the duration of the study.

You may not qualify if:

• 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.
• Have a habitual alcohol consumption of \>2 alcoholic beverages/day (\>28g ethanol daily).
• Follow a vegetarian or vegan diet.
• Have a typical fibre intake of \>30g per day.
• Have experienced major dietary changes within three months before the study baseline.
• Plan major lifestyle changes (diet, physical activity, or travel) during the study period.
• Have a clinically diagnosed eating disorder.
• Have a food allergy or intolerance that would preclude study product intake (for example, eggs, gluten, nuts, milk, or any other food allergy or intolerance).
• Have an active gastrointestinal disorder or previous gastrointestinal surgery.
• Have a significant active and medically-diagnosed acute or chronic co-existing illness including: metabolic, psychiatric, cardiovascular, endocrinological, immunological condition, gastrointestinal disease or any other condition which contraindicates, in the investigator's judgement, entry to the study (such as, diarrhoea, Crohn's disease, ulcerative colitis, IBS, diverticulosis, stomach or duodenal ulcers, hepatitis A/B/C, HIV, cancer, diabetes etc) or a significant history of such diseases.
• Are severely immunocompromised (e.g., HIV positive, transplant patient, on anti-rejection medications, on a steroid for \>30 days, or chemotherapy or radiotherapy within the last 12 months).
• Have a malignant disease or concomitant end-stage organ disease.

Sponsors & Collaborators

• University College Cork: lead

Study Sites (1)

University College Cork

Cork, Ireland

RECRUITING

MeSH Terms

Conditions

Metabolic Diseases; Diabetes Mellitus, Type 2; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Endocrine System Diseases

Study Officials

• Jens Walter, PhD

  University College Cork; University of Alberta

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Manon Oliero, PhD

CONTACT

+353 (0)86 199 2919; sconestudy@ucc.ie

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-blinded, randomised, crossover

Study Record Dates

• First Submitted: December 15, 2025
• First Posted: February 19, 2026
• Study Start: August 18, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE

Locations

IE (1)