Clinical Trials Directory

Trials / Completed

CompletedNCT04999280

Fiber-enriched Croissant Consumption and Effects on Metabolic Status, Appetite and Gut Microbiota

Effect of Daily Consumption of a Fiber-enriched Croissant on Metabolic Status, Dietary Habits and Gut Microbiota in Healthy Subjects (CROMA)

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
32 (actual)
Sponsor
Federico II University · Academic / Other
Sex
All
Age
18 Years – 50 Years
Healthy volunteers
Accepted

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.

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

Interventions

TypeNameDescription
OTHERFiber Croissant (FIBCRO) GroupSubjects 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.
OTHERControl Croissant (CONCRO) GroupSubjects 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.

Timeline

Start date
2021-09-01
Primary completion
2022-04-30
Completion
2022-06-30
First posted
2021-08-10
Last updated
2023-01-12

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT04999280. Inclusion in this directory is not an endorsement.