The Satiety Control Optimization by Nutritional Enhancement Study

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

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
* Have symptomatic respiratory or cardiac illness.
* Experience alarm features such as sudden weight loss, rectal bleeding, a recent change in bowel habits, or significant abdominal pain within three months before baseline.
* Individuals who, in the opinion of the investigator, are poor attendees or unlikely for any reason to be able to comply with the study protocol.
* Are receiving treatment involving experimental drugs.
* If the participant has been in a recent experimental trial, these must have been completed not less than 30 days before this study.
* Individuals who regularly undertake rigorous exercise.
* Individuals who smoke or vape.

Conditions2

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