HealthyCROMANCT04999280
Fiber-enriched Croissant Consumption and Effects on Metabolic Status, Appetite and Gut Microbiota
A study testing Fiber Croissant (FIBCRO) Group in people with Healthy and Overweight and Obesity, run by Federico II University at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Overweight and Obesity
- What is being tested?
- Fiber Croissant (FIBCRO) Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2021to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy subjects;
- men and women;
- age 18-50 years;
- 20 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;
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- intake of fruit/vegetables < 3 servings/day;
- low level of physical activity;
- signed written informed consent.
Who cannot join
- food allergies and intolerances and celiac disease;
- gastrointestinal diseases;
- relevant diseases;
- pregnant or breastfeeding;
- previous abdominal surgery;
- hypertriglyceridemia (Triglycerides > 200 mg/dL);
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- 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;
- simultaneous participation in other trial.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Department of Agricultural Sciences, Federico II University
Portici, 80055
About this study
Official title: Effect of Daily Consumption of a Fiber-enriched Croissant on Metabolic Status, Dietary Habits and Gut Microbiota in Healthy Subjects (CROMA)
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.
Read the detailed description
Associations between human health, diet and gut microbiota composition and functionality have been widely highlighted by the scientific literature in this field. Evidence shows that population adopting a Western dietary model, with a reduced intake of dietary fiber, undergo an adaptation of the gut microbiota characterized by the loss of some bacterial species and a general reduction in microbial biodiversity. The national guidelines for a healthy diet suggest to include daily fruit, vegetables, whole grains and legumes (the main sources of fiber in the diet) in the habitual diet to reduce the risk of diseases and to improve health. However, the compliance with these nutritional recommendations is generally low among individuals. Therefore, the commercial availability of dietary fiber-enriched products could be advantageous.
Breakfast is an important meal that should provide at least 20% of the daily calories with an adequate supply of all nutrients. Having fiber-enriched foods for breakfast could bring numerous nutritional benefits and if they are made with sourdough may be even better. Indeed, sourdough leavened baked products provide compounds with potential prebiotic activity, reduce the glucose and insulin response, increase satiety and reduce gastro-intestinal disorders upon consumption.
The hypothesis is that the combination of sourdough and dietary fiber in baked products could further ameliorate glucose metabolism in consumers compared to sourdough products.
The aim of this study is to evaluate the effects of a daily consumption at breakfast for 2 weeks of a sourdough croissant enriched with dietary fibers from 10 different sources vs a sourdough croissant with no fiber added (control) on daily energy intakes, metabolic and inflammatory status, appetite feelings, body weight, body mass index (BMI), waist and hip circumferences, body composition, blood pressure, gut microbiota composition and gastrointestinal functionality in healthy subjects.
- Conditions
- Healthy, Overweight and Obesity
- Being tested
- Fiber Croissant (FIBCRO) Group, Control Croissant (CONCRO) Group
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fiber Croissant (FIBCRO) GroupOther
Also called Fiber-enriched Croissant
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.
Control Croissant (CONCRO) GroupOther
Also called Control Croissant
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.
| Study group | Role | What they receive |
|---|---|---|
| Fiber Croissant (FIBCRO) Group | Experimental | Daily consumption at breakfast for 2 weeks of a fiber-enriched croissant Receives: Other: Fiber Croissant (FIBCRO) Group |
| Control Croissant (CONCRO) Group | Active comparator | Daily consumption at breakfast for 2 weeks of a control croissant Receives: Other: Control Croissant (CONCRO) Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation of daily energy intakes
Calculation of total daily energy intakes based on 7 days food records
Measured: 2 weeks
Secondary outcomes (22)
Changes in fasting plasma inflammatory markers
Measure of plasma C-reactive protein (mmol/L)
Measured: 2 weeks
Changes in fasting plasma lipids
Measure of plasma concentrations (mg/dL) of Total-, LDL-, and HDL-Cholesterol, as well as Triglycerides
Measured: 2 weeks
Changes in fasting blood glucose
Measure of blood glucose concentrations (mg/dL)
Measured: 2 weeks
Variation of serum Insulin hormone concentration
Measure of serum Insulin concentrations (mg/dL)
Measured: 2 weeks
Variation of plasma endocannabinoids and N-acyl-ethanolamines concentration
Measure of plasma endocannabinoids and N-acyl-ethanolamines concentrations (mg/dL)
Measured: 2 weeks
Variation of serum dipeptidyl-dipeptidase-IV activity
Measure of serum dipeptidyl-dipeptidase-IV (U/L) activity
Measured: 2 weeks
Variation of urinary excretion levels of polyphenols
Measure of polyphenols concentration in urine by mean of liquid chromatography coupled with tandem mass spectrometry (LC/MS/MS)
Measured: 2 weeks
Variation of urinary excretion levels of urolithins
Measure of urolithins concentration in urine by mean of LC/MS/MS
Measured: 2 weeks
Changes in stool consistency
Measure of consistency of feces by mean of King's stool chart filled out by subjects. The chart comprises four categories of stool consistency: hard and formed, soft and formed, loose and unformed, liquid.
Measured: 2 weeks
Changes in stool weight
Measure of stool weight by mean of King's stool chart filled out by subjects. The chart comprises three categories of stool weight : <100 g, 100-200 g, >200 g.
Measured: 2 weeks
Changes in stool frequency
Measure of frequency of feces by mean of King's stool chart filled out by subjects. Fecal frequency is incorporated by recording the code of each feces passed over a 24 hour period.
Measured: 2 weeks
Changes in gastrointestinal functionality
Calculation of daily fecal score from summation of all scores for stool consistency, weight and frequency obtained from King's stool chart filled out by subjects. Scores are weighted such that an increase in fecal frequency alone results in a higher score than a change in fecal consistency alone, which in turn results in a higher score than an increase in fecal weight alone. Diarrhea is classified by a daily fecal score of 15 or more.
Measured: 2 weeks
Changes in faecal microbiome
The composition of faecal microbiome will be determined by high throughput sequencing of the ribosomal ribonucleic acid 16S (16S rRNA) gene. The massive number of sequences obtained will be analyzed by using state of the art bioinformatics tools and the presence and relative abundance of the microbial species occurring in each sample will be determined.
Measured: 2 weeks
Changes in body weight
Measure of body weight in fasting subjects
Measured: 2 weeks
Changes in body mass index
Calculation of body mass index by using the formula weight in kilograms divided by height in meters squared.
Measured: 2 weeks
Changes in waist circumference
Measure of waist circumference at the midpoint between the lower margin of the least palpable rib and the top of the iliac crest.
Measured: 2 weeks
Changes in hip circumference
Measure of hip circumference around the widest portion of the buttocks.
Measured: 2 weeks
Changes in blood pressure
Measure of systolic pressure and diastolic pressure in millimetres of mercury (mmHg) by using a digital sphygmomanometer
Measured: 2 weeks
Changes in body composition
Body composition is determined by conventional bioelectrical impedance analysis with a single-frequency 50 kilohertz (kHz) bioelectrical impedance analyzer in the postabsorptive state (fasting subjects) and after being in the supine position for 20 min. Body composition data will be calculated from bioelectrical measurements and anthropometric data by using validated predictive equations.
Measured: 2 weeks
Variation of hunger feeling scores
Measures of hunger sensation over the day reported by subjects by using hunger Visual Analogue Scales (VAS) 0-10 centimeters (where 0 corresponds to the lowest and 10 to the highest feeling the individual could perceive). Changes in these scores may reflect potential effects of dietary intervention in modulating hunger.
Measured: 2 weeks
Variation of fullness feeling scores
Measure of fullness sensation over the day reported by subjects by using fullness Visual Analogue Scales (VAS) 0-10 centimeters (where 0 corresponds to the lowest and 10 to the highest feeling the individual could perceive). Changes in these scores may reflect potential effects of dietary intervention in modulating fullness.
Measured: 2 weeks
Variation of satiety feeling scores
Measure of satiety sensation over the day reported by subjects by using satiety Visual Analogue Scales (VAS) 0-10 centimeters (where 0 corresponds to the lowest and 10 to the highest feeling the individual could perceive). Changes in these scores may reflect potential effects of dietary intervention in modulating satiety.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2021
- Study start1 Sep 2021
- Primary completion30 Apr 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paola Vitaglione, Federico II University
- Investigators
- Paola Vitaglione, Professor, Study director, Department of Agricultural Sciences, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04999280
- Sponsor's protocol ID
- CROMA
- Acronym
- CROMA
- Status last verified
- Jan 2023
- First submitted
- 5 Aug 2021
- Last updated
- 12 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39179206
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Daily Consumption of a Fiber-enriched Croissant on Metabolic Status, Dietary Habits and Gut Microbiota in Healthy Subjects (CROMA)
- ClinicalTrials.gov ID
- NCT04999280
- Acronym / sponsor ID
- CROMA / CROMA
- Conditions
- Healthy, Overweight and Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 10 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Associations between human health, diet and gut microbiota composition and functionality have been widely highlighted by the scientific literature in this field. Evidence shows that population adopting a Western dietary model, with a reduced intake of dietary fiber, undergo an adaptation of the gut microbiota characterized by the loss of some bacterial species and a general reduction in microbial biodiversity. The national guidelines for a healthy diet suggest to include daily fruit, vegetables, whole grains and legumes (the main sources of fiber in the diet) in the habitual diet to reduce the risk of diseases and to improve health. However, the compliance with these nutritional recommendations is generally low among individuals. Therefore, the commercial availability of dietary fiber-enriched products could be advantageous.
Breakfast is an important meal that should provide at least 20% of the daily calories with an adequate supply of all nutrients. Having fiber-enriched foods for breakfast could bring numerous nutritional benefits and if they are made with sourdough may be even better. Indeed, sourdough leavened baked products provide compounds with potential prebiotic activity, reduce the glucose and insulin response, increase satiety and reduce gastro-intestinal disorders upon consumption.
The hypothesis is that the combination of sourdough and dietary fiber in baked products could further ameliorate glucose metabolism in consumers compared to sourdough products.
The aim of this study is to evaluate the effects of a daily consumption at breakfast for 2 weeks of a sourdough croissant enriched with dietary fibers from 10 different sources vs a sourdough croissant with no fiber added (control) on daily energy intakes, metabolic and inflammatory status, appetite feelings, body weight, body mass index (BMI), waist and hip circumferences, body composition, blood pressure, gut microbiota composition and gastrointestinal functionality in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fiber Croissant (FIBCRO) Group | Experimental | Other: Fiber Croissant (FIBCRO) GroupDaily consumption at breakfast for 2 weeks of a fiber-enriched croissant |
| Control Croissant (CONCRO) Group | Active comparator | Other: Control Croissant (CONCRO) GroupDaily consumption at breakfast for 2 weeks of a control croissant |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- healthy subjects;
- men and women;
- age 18-50 years;
- 20 kg/m2 ≤ BMI ≤ 35 kg/m2;
- habitual daily breakfast consumption (≥ 250kcal/day);
Key exclusion criteria (16 listed)
- food allergies and intolerances and celiac disease;
- gastrointestinal diseases;
- relevant diseases;
- pregnant or breastfeeding;
- previous abdominal surgery;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fiber Croissant (FIBCRO) GroupAlso: Fiber-enriched CroissantSubjects 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. | Other | Fiber Croissant (FIBCRO) Group |
| Control Croissant (CONCRO) GroupAlso: Control CroissantSubjects 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. | Other | Control Croissant (CONCRO) Group |
Primary outcome
Variation of daily energy intakes
Time frame: 2 weeks
Calculation of total daily energy intakes based on 7 days food records
22 secondary outcomes
Changes in fasting plasma inflammatory markers
Time frame: 2 weeks
Changes in fasting plasma lipids
Time frame: 2 weeks
Changes in fasting blood glucose
Time frame: 2 weeks
Variation of serum Insulin hormone concentration
Time frame: 2 weeks
Variation of plasma endocannabinoids and N-acyl-ethanolamines concentration
Time frame: 2 weeks
Variation of serum dipeptidyl-dipeptidase-IV activity
Time frame: 2 weeks
Variation of urinary excretion levels of polyphenols
Time frame: 2 weeks
Variation of urinary excretion levels of urolithins
Time frame: 2 weeks
Changes in stool consistency
Time frame: 2 weeks
Changes in stool weight
Time frame: 2 weeks
Changes in stool frequency
Time frame: 2 weeks
Changes in gastrointestinal functionality
Time frame: 2 weeks
Changes in faecal microbiome
Time frame: 2 weeks
Changes in body weight
Time frame: 2 weeks
Changes in body mass index
Time frame: 2 weeks
Changes in waist circumference
Time frame: 2 weeks
Changes in hip circumference
Time frame: 2 weeks
Changes in blood pressure
Time frame: 2 weeks
Changes in body composition
Time frame: 2 weeks
Variation of hunger feeling scores
Time frame: 2 weeks
Variation of fullness feeling scores
Time frame: 2 weeks
Variation of satiety feeling scores
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2023.
- Derived from this study: PubMed 39179206Barone 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paola Vitaglione, Professor study director
Department of Agricultural Sciences, Federico II University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fiber Croissant (FIBCRO) Group in people with Healthy and Overweight and Obesity, run by Federico II University at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variation of daily energy intakes (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04999280, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2023.