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Completed

NCT Number: NCT05443828

Plasma SCFAs After Fermentable Cereal Fibres - A 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.

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Key information

Conditions

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

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Clinical Medicine and Surgery Federico II University

Naples, 80131, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Other names: Breakfast Meal with vitacel puff

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.

Other names: Breakfast Meal with AX bread

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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.

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Registry information

Official study title

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

Acronym: FIFERM

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 5, 2022
Registry last updated
Jul 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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