Actively Recruiting

Phase Not Applicable
Age: 18Years - 45Years
All Genders
Healthy Volunteers
NCT07420023

The Satiety Control Optimization by Nutritional Enhancement Study

Led by University College Cork · Updated on 2026-02-19

24

Participants Needed

1

Research Sites

36 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

The Satiety Control Optimization by Nutritional Enhancement Study

Who Can Participate

Age: 18Years - 45Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Willing and able to provide written informed consent
  • Aged between 18 and 45 years
  • Body mass index (BMI) between 25 and less than 30 kg/m2 (overweight)
  • Waist circumference greater than 94 cm for males or greater than 80 cm for females
  • Stable body weight with less than 5% change over the past three months
  • Generally good health with systolic blood pressure below 160 mm Hg and diastolic blood pressure below 100 mm Hg
  • Willing to avoid dietary supplements, prebiotics, probiotics, or fibre-rich supplements for four weeks before baseline and during the study
  • Willing to avoid vigorous physical activities on intervention days
  • Willing to consume the study food products and menu plan daily throughout the study
Not Eligible

You will not qualify if you...

  • Pregnant, lactating, post-menopausal women, or planning pregnancy during the study
  • Antibiotic treatment within three months before baseline
  • Taking medications that interfere with study objectives or safety, including anti-inflammatory drugs, H2 blockers, antacids, proton pump inhibitors, anti-hypertensive medications, corticosteroids, laxatives, enemas, antibiotics, anti-coagulants, or immunosuppressants unless stable for two months
  • History or current drug or alcohol abuse
  • Habitual alcohol consumption over two alcoholic drinks per day
  • Following vegetarian or vegan diet
  • Typical daily fibre intake over 30 grams
  • Major dietary changes within three months before baseline
  • Planning major lifestyle changes during the study
  • Diagnosed eating disorder
  • Food allergy or intolerance preventing study product intake (e.g., eggs, gluten, nuts, milk)
  • Active gastrointestinal disorder or previous gastrointestinal surgery
  • Significant acute or chronic medical conditions contraindicating study participation
  • Severely immunocompromised status
  • Malignant disease or end-stage organ disease
  • Symptomatic respiratory or cardiac illness
  • Recent alarming symptoms such as weight loss, rectal bleeding, bowel changes, or severe abdominal pain
  • Poor attendance or inability to comply with study protocol
  • Receiving experimental drug treatments
  • Participation in another experimental trial within 30 days
  • Regularly undertaking rigorous exercise
  • Smoking or vaping

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

University College Cork

Cork, Ireland

Actively Recruiting

Loading map...

Research Team

M

Manon Oliero, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

BASIC_SCIENCE

Number of Arms

3

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here