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)

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.

Study Overview

• Status: Completed
• Conditions: Healthy; Overweight and Obesity
• Intervention / Treatment: Other: Fiber Croissant (FIBCRO) Group; Other: Control Croissant (CONCRO) Group

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 Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Portici, Italy, 80055
    • Department of Agricultural Sciences, Federico II University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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;
• intake of fruit/vegetables < 3 servings/day;
• low level of physical activity;
• signed written informed consent.

Exclusion Criteria:

• 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;
• simultaneous participation in other trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fiber Croissant (FIBCRO) Group; Daily consumption at breakfast for 2 weeks of a fiber-enriched croissant	Other: Fiber Croissant (FIBCRO) Group; 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.; Other Names: Fiber-enriched Croissant
Active Comparator: Control Croissant (CONCRO) Group; Daily consumption at breakfast for 2 weeks of a control croissant	Other: Control Croissant (CONCRO) Group; 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.; Other Names: Control Croissant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Variation of daily energy intakes	Calculation of total daily energy intakes based on 7 days food records	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in fasting plasma inflammatory markers	Measure of plasma C-reactive protein (mmol/L)	2 weeks
Changes in fasting plasma lipids	Measure of plasma concentrations (mg/dL) of Total-, LDL-, and HDL-Cholesterol, as well as Triglycerides	2 weeks
Changes in fasting blood glucose	Measure of blood glucose concentrations (mg/dL)	2 weeks
Variation of serum Insulin hormone concentration	Measure of serum Insulin concentrations (mg/dL)	2 weeks
Variation of plasma endocannabinoids and N-acyl-ethanolamines concentration	Measure of plasma endocannabinoids and N-acyl-ethanolamines concentrations (mg/dL)	2 weeks
Variation of serum dipeptidyl-dipeptidase-IV activity	Measure of serum dipeptidyl-dipeptidase-IV (U/L) activity	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)	2 weeks
Variation of urinary excretion levels of urolithins	Measure of urolithins concentration in urine by mean of LC/MS/MS	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.	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.	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.	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.	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.	2 weeks
Changes in body weight	Measure of body weight in fasting subjects	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.	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.	2 weeks
Changes in hip circumference	Measure of hip circumference around the widest portion of the buttocks.	2 weeks
Changes in blood pressure	Measure of systolic pressure and diastolic pressure in millimetres of mercury (mmHg) by using a digital sphygmomanometer	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.	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.	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.	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.	2 weeks

Collaborators and Investigators

• Sponsor: Federico II University
• Investigators: Study Director: Paola Vitaglione, Professor, Department of Agricultural Sciences, Federico II University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Actual): April 30, 2022
• Study Completion (Actual): June 30, 2022

Study Registration Dates

• First Submitted: August 5, 2021
• First Submitted That Met QC Criteria: August 5, 2021
• First Posted (Actual): August 10, 2021

Study Record Updates

• Last Update Posted (Actual): January 12, 2023
• Last Update Submitted That Met QC Criteria: January 11, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Overweight
• Other Study ID Numbers: CROMA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No