Plasma SCFAs After Fermentable Cereal Fibres - A Postprandial Study
NCT ID: NCT05443828
Last Updated: 2022-07-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
22 participants
INTERVENTIONAL
2021-11-09
2022-05-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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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
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.
AX bread
Participants consumed a portion of bread enriched with arabynoxylans (AX) contained 11 g of fiber, in the context of a breakfast meal
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.
Wheat bran puff
Participants consumed a portion of wheat bran puff contained 11 g of fiber, in the context of a breakfast meal
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.
Interventions
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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.
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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
30 Years
75 Years
ALL
Yes
Sponsors
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Federico II University
OTHER
Responsible Party
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rivellese angela
Full Professor
Principal Investigators
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Angela Rivellese, MD
Role: STUDY_CHAIR
Federico II University
Locations
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Department of Clinical Medicine and Surgery Federico II University
Naples, , Italy
Countries
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References
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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.
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.
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.
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.
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.
Other Identifiers
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299/20
Identifier Type: -
Identifier Source: org_study_id
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