Fiber-enriched Croissant Consumption and Effects on Metabolic Status, Appetite and Gut Microbiota
CROMA
Effect of Daily Consumption of a Fiber-enriched Croissant on Metabolic Status, Dietary Habits and Gut Microbiota in Healthy Subjects (CROMA)
1 other identifier
interventional
32
1 country
1
Brief Summary
The aim of this study is to evaluate the effect of a daily consumption for 2 weeks of a sourdough croissant enriched with dietary fibers vs a control sourdough croissant with no fiber added on daily energy intakes, fasting metabolic parameters, inflammatory status, blood pressure, anthropometric measures, body composition, appetite sensations, gastrointestinal functionality and gut microbiota composition.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable healthy
Started Sep 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 5, 2021
CompletedFirst Posted
Study publicly available on registry
August 10, 2021
CompletedStudy Start
First participant enrolled
September 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2022
CompletedJanuary 12, 2023
January 1, 2023
8 months
August 5, 2021
January 11, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Variation of daily energy intakes
Calculation of total daily energy intakes based on 7 days food records
2 weeks
Secondary Outcomes (22)
Changes in fasting plasma inflammatory markers
2 weeks
Changes in fasting plasma lipids
2 weeks
Changes in fasting blood glucose
2 weeks
Variation of serum Insulin hormone concentration
2 weeks
Variation of plasma endocannabinoids and N-acyl-ethanolamines concentration
2 weeks
- +17 more secondary outcomes
Study Arms (2)
Fiber Croissant (FIBCRO) Group
EXPERIMENTALDaily consumption at breakfast for 2 weeks of a fiber-enriched croissant
Control Croissant (CONCRO) Group
ACTIVE COMPARATORDaily consumption at breakfast for 2 weeks of a control croissant
Interventions
Subjects will consume for 2 weeks at breakfast a fiber-enriched sourdough croissant. All subjects will be requested not to change other dietary habits and their physical activity during the 2 week intervention period.
Subjects will consume for 2 weeks at breakfast a sourdough croissant. All subjects will be requested not to change other dietary habits and their physical activity during the 2 week intervention period.
Eligibility Criteria
You may qualify if:
- healthy subjects;
- men and women;
- age 18-50 years;
- kg/m2 ≤ BMI ≤ 35 kg/m2;
- habitual daily breakfast consumption (≥ 250kcal/day);
- habitual diet characterized by absence of any food supplements and alternative medication, probiotics and prebiotics, whole grain and/or fiber enriched foods;
- intake of fruit/vegetables \< 3 servings/day;
- low level of physical activity;
- signed written informed consent.
You may not qualify if:
- food allergies and intolerances and celiac disease;
- gastrointestinal diseases;
- relevant diseases;
- pregnant or breastfeeding;
- previous abdominal surgery;
- hypertriglyceridemia (Triglycerides \> 200 mg/dL);
- hypercholesterolemia (Total cholesterol \> 200 mg/dL);
- hyperglycaemia (glycaemia ≥ 110 mg/dL);
- hypertension (arterial blood pressure ≥140/90 mm Hg);
- weight loss ≥ 3 kg within 2 months before the study;
- antibiotics treatment within 3 months before the study;
- any medication (different from antibiotics) at the enrollment and within 2 months before the study;
- habitual diet characterized by high fruit and vegetables intakes (\>3 portion/die);
- high level of physical activity;
- alcohol consumption ≥ 3 alcohol units per day;
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Agricultural Sciences, Federico II University
Portici, 80055, Italy
Related Publications (1)
Barone Lumaga R, Tagliamonte S, De Rosa T, Valentino V, Ercolini D, Vitaglione P. Consumption of a Sourdough-Leavened Croissant Enriched with a Blend of Fibers Influences Fasting Blood Glucose in a Randomized Controlled Trial in Healthy Subjects. J Nutr. 2024 Oct;154(10):2976-2987. doi: 10.1016/j.tjnut.2024.08.015. Epub 2024 Aug 22.
PMID: 39179206DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Paola Vitaglione, Professor
Department of Agricultural Sciences, Federico II University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
August 5, 2021
First Posted
August 10, 2021
Study Start
September 1, 2021
Primary Completion
April 30, 2022
Study Completion
June 30, 2022
Last Updated
January 12, 2023
Record last verified: 2023-01