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

Primary Purpose

Overweight and Obesity

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Breakfast Control Meal
Breakfast Test Meal
Breakfast Test Meal
Sponsored by
Federico II University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight and Obesity focused on measuring dietary fiber, short chain fatty acids, butyrate, propionate, gut microbiota, glucose metabolism

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Department of Clinical Medicine and Surgery Federico II University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Extruded puff with vitacel

AX bread

Wheat bran puff

Arm Description

The participants consumed a portion of extruded puff with added vitacel (cellulose) contained 11 g of fiber, in the context of a breakfast meal

Participants consumed a portion of bread enriched with arabynoxylans (AX) contained 11 g of fiber, in the context of a breakfast meal

Participants consumed a portion of wheat bran puff contained 11 g of fiber, in the context of a breakfast meal

Outcomes

Primary Outcome Measures

Differences in plasma propionate and butyrate concentration
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

Secondary Outcome Measures

Effects of the different fibres sources on plasma glucose
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
Effects of the different fibres sources on plasma insulin
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
Effects of the different fibres sources on plasma free fatty acids
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
Effects of the different fibres sources on plasma GLP-1
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
Gut microbiota composition
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.

Full Information

First Posted
June 14, 2022
Last Updated
June 29, 2022
Sponsor
Federico II University
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1. Study Identification

Unique Protocol Identification Number
NCT05443828
Brief Title
Plasma SCFAs After Fermentable Cereal Fibres - A Postprandial Study
Acronym
FIFERM
Official Title
Short-chain Fatty Acids in Plasma After Intake of Fermentable Cereal Fibres- An Extended Postprandial Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
November 9, 2021 (Actual)
Primary Completion Date
May 24, 2022 (Actual)
Study Completion Date
May 24, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federico II University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity
Keywords
dietary fiber, short chain fatty acids, butyrate, propionate, gut microbiota, glucose metabolism

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Extruded puff with vitacel
Arm Type
Active Comparator
Arm Description
The participants consumed a portion of extruded puff with added vitacel (cellulose) contained 11 g of fiber, in the context of a breakfast meal
Arm Title
AX bread
Arm Type
Experimental
Arm Description
Participants consumed a portion of bread enriched with arabynoxylans (AX) contained 11 g of fiber, in the context of a breakfast meal
Arm Title
Wheat bran puff
Arm Type
Experimental
Arm Description
Participants consumed a portion of wheat bran puff contained 11 g of fiber, in the context of a breakfast meal
Intervention Type
Other
Intervention Name(s)
Breakfast Control Meal
Other Intervention Name(s)
Breakfast Meal with vitacel puff
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Breakfast Test Meal
Other Intervention Name(s)
Breakfast Meal with AX bread
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Breakfast Test Meal
Other Intervention Name(s)
Breakfast Meal with extruded puff with added wheat bran
Intervention Description
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.
Primary Outcome Measure Information:
Title
Differences in plasma propionate and butyrate concentration
Description
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
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Effects of the different fibres sources on plasma glucose
Description
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
Time Frame
24 hours
Title
Effects of the different fibres sources on plasma insulin
Description
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
Time Frame
24 hours
Title
Effects of the different fibres sources on plasma free fatty acids
Description
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
Time Frame
24 hours
Title
Effects of the different fibres sources on plasma GLP-1
Description
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
Time Frame
24 hours
Title
Gut microbiota composition
Description
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.
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Angela Rivellese, MD
Organizational Affiliation
Federico II University
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Clinical Medicine and Surgery Federico II University
City
Naples
ZIP/Postal Code
80131
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30696735
Citation
Baxter NT, Schmidt AW, Venkataraman A, Kim KS, Waldron C, Schmidt TM. Dynamics of Human Gut Microbiota and Short-Chain Fatty Acids in Response to Dietary Interventions with Three Fermentable Fibers. mBio. 2019 Jan 29;10(1):e02566-18. doi: 10.1128/mBio.02566-18.
Results Reference
result
PubMed Identifier
30264354
Citation
Chambers ES, Preston T, Frost G, Morrison DJ. Role of Gut Microbiota-Generated Short-Chain Fatty Acids in Metabolic and Cardiovascular Health. Curr Nutr Rep. 2018 Dec;7(4):198-206. doi: 10.1007/s13668-018-0248-8.
Results Reference
result
PubMed Identifier
28713163
Citation
Kim CH. Microbiota or short-chain fatty acids: which regulates diabetes? Cell Mol Immunol. 2018 Feb;15(2):88-91. doi: 10.1038/cmi.2017.57. Epub 2017 Jul 17. No abstract available.
Results Reference
result
PubMed Identifier
26552345
Citation
Kovatcheva-Datchary P, Nilsson A, Akrami R, Lee YS, De Vadder F, Arora T, Hallen A, Martens E, Bjorck I, Backhed F. Dietary Fiber-Induced Improvement in Glucose Metabolism Is Associated with Increased Abundance of Prevotella. Cell Metab. 2015 Dec 1;22(6):971-82. doi: 10.1016/j.cmet.2015.10.001. Epub 2015 Nov 6.
Results Reference
result

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Plasma SCFAs After Fermentable Cereal Fibres - A Postprandial Study

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