Plasma SCFAs After Fermentable Cereal Fibres - A Postprandial Study (FIFERM)

June 29, 2022 updated by: rivellese angela, Federico II University

Short-chain Fatty Acids in Plasma After Intake of Fermentable Cereal Fibres- An Extended Postprandial Study

Circulating SCFAs reflect the net effect of what is produced in the large intestine from dietary fibre fermentation, bioavailability after considerable absorption by the enterocytes and in the liver and the elimination. It is yet unclear to what extent SCFA levels in systemic circulation is of importance for metabolic disease risk and diabetes aetiology. Recent high-impact studies strongly suggest beneficial metabolic effects of butyrate and adverse effects from propionate However, no study has yet investigated to what extent butyrate or propionate producing diets may influence metabolic risk factors for T2D across individuals with different butyrate or propionate producing capacity. The overall aim is to investigate individual's ability to generate high concentrations of butyrate and propionate in plasma after acute intake of different fibre rich foods in an extended postprandial setting. The aim is further to optimize time points for data collection to allow robust assessment of plasma-time concentration profiles of butyrate and propionate to establish a screening approach to identify individuals with high/low butyrate/propionate plasma concentrations. This will be used in later precision nutrition studies where diet will be tailored to high/low SCFA-metabotypes.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
22

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Naples, Italy, 80131
        • Department of Clinical Medicine and Surgery Federico II University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

30 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Body mass index (BMI) 20-35 kg/m2
  • Waist circumference >102 cm (males) or 88 cm (females)
  • Haemoglobin, low density lipoprotein (LDL) cholesterol or triglycerides within the normal reference ranges (age and sex specific) according to the laboratory analysing the screening samples.
  • Willing to collect faecal samples at home and store them in their household freezer

Exclusion Criteria:

  • Blood donation or participation in a clinical study with blood sampling within 30 days prior to screening visit and throughout the study
  • Having been treated with antibiotics within the past 3 months or planning to undergo treatment during the study period.
  • Diastolic blood pressure ³ 105 mm Hg at visit 1
  • Systolic blood pressure ³ 160 mm at visit 1
  • History of stomach or gastrointestinal conditions (Inflammatory bowel disease, Crohn's disease, malabsorption etc.)
  • More than 10 hours physical activity per week
  • History of heart failure or heart attack within 1 year prior to screening
  • Having type I and type 2 diabetes
  • Previous gastrointestinal surgery (e.g., gastric bypass, gastric sleeve, bowel resection, colostomy etc.), with the exception of minor surgeries such removal of appendix or gall bladder at least 6 months prior to screening.
  • Thyroid disorder not controlled by drug therapy
  • History of drug or alcohol abuse
  • Stroke or transient ischemic attack (TIA) within 1 year prior to screening
  • Consumption of drugs aimed at weight management or drugs affecting body weight to a degree that is considered unsuitable for study participation by responsible physician.
  • Pregnant, lactation or planning a pregnancy within the timeframe of the study. Pregnancy must have ended at least 6 months prior to screening, and lactation must have ended at least 1 month prior to screening.
  • Food allergies or intolerances preventing consumption of any products included in the study
  • Strict vegetarian/vegan (participants must be able to consume the standardized meals used in the study)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Extruded puff with vitacel
The participants consumed a portion of extruded puff with added vitacel (cellulose) contained 11 g of fiber, in the context of a breakfast meal
Other: Breakfast Control Meal
The participants consumed extruded puff with added vitacel (cellulose) as part of the breakfast meal (400 kcal, 12 g fiber) followed by consumption of standardised meal at lunch and dinner . The lunch and dinner did noft contain any intervention products. Blood samples were collected at 14 timepoints drawn (first sample 15 minutes before breakfast, last sample 24 hours after breakfast), during 6 hours after the test breakfast meal and during other 2 hours after standardised lunch.
Other Names:
  • Breakfast Meal with vitacel puff
Experimental: AX bread
Participants consumed a portion of bread enriched with arabynoxylans (AX) contained 11 g of fiber, in the context of a breakfast meal
Other: Breakfast Test Meal
The participants consumed bread with added arabynoxylans (AX) as part of the breakfast meal (400 kcal, 12 g fiber) followed by consumption of standardised meal at lunch and dinner . The lunch and dinner did noft contain any intervention products. Blood samples were collected at 14 timepoints drawn (first sample 15 minutes before breakfast, last sample 24 hours after breakfast), during 6 hours after the test breakfast meal and during other 2 hours after standardised lunch.
Other Names:
  • Breakfast Meal with AX bread
Other: Breakfast Test Meal
The participants consumed extruded puff with added wheat bran as part of the breakfast meal (400 kcal, 12 g fiber) followed by consumption of standardised meal at lunch and dinner . The lunch and dinner did noft contain any intervention products. Blood samples were collected at 14 timepoints drawn (first sample 15 minutes before breakfast, last sample 24 hours after breakfast), during 6 hours after the test breakfast meal and during other 2 hours after standardised lunch.
Other Names:
  • Breakfast Meal with extruded puff with added wheat bran
Experimental: Wheat bran puff
Participants consumed a portion of wheat bran puff contained 11 g of fiber, in the context of a breakfast meal
Other: Breakfast Test Meal
The participants consumed bread with added arabynoxylans (AX) as part of the breakfast meal (400 kcal, 12 g fiber) followed by consumption of standardised meal at lunch and dinner . The lunch and dinner did noft contain any intervention products. Blood samples were collected at 14 timepoints drawn (first sample 15 minutes before breakfast, last sample 24 hours after breakfast), during 6 hours after the test breakfast meal and during other 2 hours after standardised lunch.
Other Names:
  • Breakfast Meal with AX bread
Other: Breakfast Test Meal
The participants consumed extruded puff with added wheat bran as part of the breakfast meal (400 kcal, 12 g fiber) followed by consumption of standardised meal at lunch and dinner . The lunch and dinner did noft contain any intervention products. Blood samples were collected at 14 timepoints drawn (first sample 15 minutes before breakfast, last sample 24 hours after breakfast), during 6 hours after the test breakfast meal and during other 2 hours after standardised lunch.
Other Names:
  • Breakfast Meal with extruded puff with added wheat bran

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Differences in plasma propionate and butyrate concentration
Time Frame: 24 hours
Differences in plasma SCFA concentration- time profiles , with emphasis on butyrate and propionate concentrations after intake of the breakfast meals cointaned the same amount of different fibre sources (wheat bran puff and Arabynoxylans bread) compared to control fiber (extruded vitacel puff). Plasma SCFAs concentration was evaluated by LC-MS analysis
24 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Effects of the different fibres sources on plasma glucose
Time Frame: 24 hours
Differences in postprandial plasma glucose concentrations after intake of the breakfast meals cointaned the same amount of different fibre sources (wheat bran puff and Arabynoxylans bread) compared to control fiber (extruded vitacel puff). Plasma glucose concentration was measured by enzymatic colorimetric methods
24 hours
Effects of the different fibres sources on plasma insulin
Time Frame: 24 hours
Differences in postprandial plasma insulin concentrations after intake of the breakfast meals cointaned the same amount of different fibre sources (wheat bran puff and Arabynoxylans bread) compared to control fiber (extruded vitacel puff). Plasma insulin concentration was measured by ELISA method
24 hours
Effects of the different fibres sources on plasma free fatty acids
Time Frame: 24 hours
Differences in postprandial plasma free fatty acids (FFA) concentrations after intake of the breakfast meals cointaned the same amount of different fibre sources (wheat bran puff and Arabynoxylans bread) compared to control fiber (extruded vitacel puff). Plasma FFA concentration was measured by enzymatic colorimetric method
24 hours
Effects of the different fibres sources on plasma GLP-1
Time Frame: 24 hours
Differences in postprandial plasma glucagon like peptide 1 (GLP1) concentrations after intake of the breakfast meals cointaned the same amount of different fibre sources (wheat bran puff and Arabynoxylans bread) compared to control fiber (extruded vitacel puff). Plasma GLP1 concentration was measured by ELISA method
24 hours
Gut microbiota composition
Time Frame: 24 hours
Analysis of the gut microbiota composition from faecal samples collected at fasting before the intake of the breakfast meals cointaned the same amount of different fibre sources (wheat bran puff and Arabynoxylans bread) compared to control fiber (extruded vitacel puff). Faecal microbiota composition was evaluated by 16S rRNA sequencing.
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Federico II University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Angela Rivellese, MD, Federico II University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 9, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 24, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 24, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 14, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 29, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 5, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 5, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 29, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 299/20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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