Plasma SCFAs After Fermentable Cereal Fibres - A Postprandial Study

NCT05443828 | Completed

• 1 other identifier: 299/20
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight and Obesity

Keywords

dietary fiber; short chain fatty acids; butyrate; propionate; gut microbiota; glucose metabolism

Outcome Measures

Primary Outcomes (1)

• 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

  24 hours

Secondary Outcomes (5)

• Effects of the different fibres sources on plasma glucose

  24 hours

• Effects of the different fibres sources on plasma insulin

  24 hours

• Effects of the different fibres sources on plasma free fatty acids

  24 hours

• Effects of the different fibres sources on plasma GLP-1

  24 hours

• Gut microbiota composition

  24 hours

Study Arms (3)

Extruded puff with vitacel

ACTIVE COMPARATOR

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

AX bread

EXPERIMENTAL

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

Wheat bran puff

EXPERIMENTAL

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

Other: Breakfast Test Meal

Interventions

Breakfast Control Meal OTHER

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.

Also known as: Breakfast Meal with vitacel puff

Extruded puff with vitacel

Breakfast Test Meal OTHER

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.

Also known as: Breakfast Meal with AX bread

AX bread

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

Department of Clinical Medicine and Surgery Federico II University

Naples, 80131, Italy

Location

Related Publications (5)

• 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.

  PMID: 30696735 RESULT

• 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.

  PMID: 30264354 RESULT

• 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.

  PMID: 28713163 RESULT

• 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.

  PMID: 26552345 RESULT

• Costabile G, Vitale M, Testa R, Rivieccio A, Palmnas M, Lopez-Sanchez P, Landberg R, Riccardi G, Giacco R. Daily profiles of plasma short-chain fatty acids after the intake of three different cereal fibers: a randomized controlled study. Eur J Nutr. 2025 Jun 11;64(5):217. doi: 10.1007/s00394-025-03741-7.

  PMID: 40498116 DERIVED

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Angela Rivellese, MD

  Federico II University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: June 14, 2022
• First Posted: July 5, 2022
• Study Start: November 9, 2021
• Primary Completion: May 24, 2022
• Study Completion: May 24, 2022
• Last Updated: July 5, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)