Probiotic in Fruit Snack (Probiotics)
A Physiological Study of a Fruit Snack Containing Probiotics
The aim of this study is to investigate whether a fruit snack containing probiotic ''Lactobacillus rhamnosus'' can survive and establish itself more effectively in the gut when it is protected inside a natural plant-protein coating and delivered in a fruit snack.
Lactobacillus rhamnosus is a beneficial bacterium that may support gut health and influence communication between the gut and the brain. In this study, we will examine how the probiotic affects the gut microbiome (the community of bacteria that naturally live in the gut).
We are recruiting 25 healthy men and women aged 25-65 years with a body mass index (BMI) between 18.5 and 31.9 kg/m². Participants will be randomly assigned to receive either:
A) Fruit snack containing encapsulated Lactobacillus rhamnosus probiotics, or a similar fruit snack that does not contain probiotics (placebo).
Neither participants nor researchers (blinded) will know which snack is being provided during the study.
Participants will attend four study visits over approximately 10 weeks (70 days): at the baseline visit Day 0 and again at Days 28, Day 42, and Day 70. A blood and stool samples will be collected at the beginning of the study, and samples will be used to assess changes in the gut microbiome over time.
The findings from this study will help us better understand how targeted delivery of probiotics to the gut may influence the gut microbiome and support digestive health.
A tanulmány áttekintése
Állapot
Körülmények
Részletes leírás
The gut microbiota plays an important role in human health through interactions with the gastrointestinal, immune, endocrine, and nervous systems. Increasing evidence suggests that the gut microbiota influences gastrointestinal and brain function through the microbiota-gut-brain axis, a bidirectional communication network linking the gastrointestinal tract and the central nervous system. Alterations in gut microbial composition have been associated with aging-related physiological changes, gastrointestinal function, inflammation, cognition, and mood.
Probiotics are live microorganisms that, when administered in adequate amounts, confer a health benefit on the host. However, the effectiveness of probiotic supplementation depends on the ability of viable microorganisms to survive food processing, storage, gastric acidity, and gastrointestinal transit before reaching their target site in the intestine. Consequently, strategies that improve probiotic survival and targeted delivery may enhance intestinal colonisation and biological activity within the gastrointestinal tract.
Microencapsulation is a promising approach for protecting probiotic bacteria during manufacturing, storage, and passage through the upper gastrointestinal tract. Encapsulation within a protective plant protein matrix may increase delivery of viable probiotic cells to the intestine by reducing exposure to gastric acid and digestive enzymes. The investigational product used in this study contains Lactobacillus rhamnosus microencapsulated using a plant protein-based delivery system and incorporated into a fruit snack.
The primary objective of this study is to determine whether daily consumption of a fruit snack containing microencapsulated Lactobacillus rhamnosus increases intestinal colonisation compared with a matched fruit snack without probiotics. Colonisation will be assessed by measuring the abundance of Lactobacillus rhamnosus in stool samples.
Secondary objectives include evaluating the effects of the intervention on gut microbiome composition and diversity, and exploring changes in markers related to gastrointestinal function and microbiota-gut-brain axis physiology.
This study is a randomised, double-blind, placebo-controlled crossover trial. Participants will complete two 28-day intervention periods separated by a 14-day washout period. Participants will receive both study interventions in a random order: (1) a fruit snack containing microencapsulated Lactobacillus rhamnosus and (2) a matched fruit snack without probiotics.
Participants will consume one 28-g serving of the assigned fruit snack each day during each intervention period. The probiotic snack contains Lactobacillus rhamnosus at a concentration of 2 × 10⁹ colony-forming units (CFU) per gram, providing a total daily dose of approximately 5.6 × 10¹⁰ CFU (56 billion CFU/day). Stool samples will be collected at predefined study visits to assess probiotic colonisation and changes in gut microbiome composition.
This study will provide evidence regarding the effectiveness of plant protein-based microencapsulation technology for probiotic delivery and improve understanding of the impact of targeted probiotic supplementation on intestinal colonisation and the human gut microbiome.
Tanulmány típusa
Beiratkozás (Tényleges)
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Tanulmányi helyek
-
-
Dublin 04
-
Dublin, Dublin 04, Írország, D04 T6F4
- Clinical Research Centre, St. Vincent's University Hospital
-
-
Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
- Felnőtt
- Idősebb felnőtt
Egészséges önkénteseket fogad
Leírás
Inclusion Criteria:
- Signed informed consent prior to any study-related procedure Age 25-65 years-old
- BMI range 18.5-31.9 kg/m2
- Willing to abstain from regular consumption of probiotic supplements or food products containing probiotic bacteria (including fermented food and beverages)
- Willing to abstain from regular consumption of supplements and medications known to alter gastrointestinal function or inflammatory status during the study
Exclusion Criteria:
- Smoking
- Substance abuse
- Pregnancy and lactaction
- Diagnosis of type 1 and/or type 2 diabetes
- Current (or within the last 4 weeks prior to study start) use of probiotic supplementation.
- Immobile (defined as the inability to participate in all study-related procedures)
- People with intellectual disabilities.
- History of complicated gastrointestinal surgery
- Diagnosed inflammatory bowel disease (IBD)
- Current diagnosis of psychiatric disease/s or syndromes
- Current diagnosis of neurodegenerative disease
- Systemic use of antibiotics and/or steroid medication in the last 4 months prior to inclusion
- Use of any non-steroidal anti-inflammatory drug (NSAID) more than 3 times a week for the last 2 months
- Consumption of any NSAID within 7 days of study start
- Any condition which could substantially interfere with intestinal barrier function (e.g. gluten sensitivity, lactose intolerance, celiac disease, IBS, IBD) or in any other way with the outcome of the study, as decided by the principle investigator's discretion
- Regular smoking, use of snuff, nicotine, cannabidiol narcotics/supplements, or e-cigarette use
- Drinking more than 9 standard cups of alcohol per week and/or more than 3 standard cups of alcohol per occasion
- Regular use, for more than three times a week for the last 2 months and/or 7 days prior to inclusion, of medications which according to the principal investigator can have an anti-inflammatory effect or affect in any way the intestinal barrier function or have an impact on the study analysis (such as laxatives, anti-diarrheal, anti-cholinergic, etc.)
- After being included in the study, starting any medication or treatment that could potentially influence the study participation and/or study analysis.
Justification: it is necessary to exclude participation from individuals with smoking or substance abuse as that may compromise the physiological gut response.
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Alapvető tudomány
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Crossover kiosztás
- Maszkolás: Kettős
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
|
Aktív összehasonlító: Experimental Arm 1
Participants receive the fruit snack containing microencapsulated Lactobacillus rhamnosus for 28 days, followed by a 14-day washout period and then the placebo fruit snack for 28 days.
|
Participants consume one 28-gram fruit snack daily containing microencapsulated Lactobacillus rhamnosus at a concentration of 2 × 10⁹ CFU/g, providing a total daily dose of approximately 5.6 × 10¹⁰ CFU (56 billion CFU/day). The probiotic is delivered in a plant protein-based microencapsulation matrix designed to enhance survival through the gastrointestinal tract and support delivery to the intestine. Arm 1: Probiotic then Placebo intervention.
Más nevek:
|
|
Placebo Comparator: Experimental Arm 2
Participants receive the placebo fruit snack for 28 days, followed by a 14-day washout period and then the fruit snack containing microencapsulated Lactobacillus rhamnosus for 28 days.
|
Participants daily consume one 28-gram fruit snack daily that is identical in appearance, taste, and texture to the active product but does not contain probiotic bacteria. The placebo snack contains the same base ingredients without Lactobacillus rhamnosus. Arm 2: Placebo then Probiotic intervention.
Más nevek:
|
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Change in faecal abundance of Lactobacillus rhamnosus
Időkeret: Baseline, Day 28, Day 42 (end of washout), Day 70 (end of second intervention period).
|
Stool samples will be collected at four time points: baseline (pre-intervention), end of the first 28-day intervention period, end of the washout period (Day 42), and end of the second 28-day intervention period (Day 70).
The abundance of Lactobacillus rhamnosus will be quantified using strain-specific molecular and/or sequencing-based microbiome analysis methods.
Changes in abundance will be compared between probiotic and placebo intervention periods in a crossover design.
|
Baseline, Day 28, Day 42 (end of washout), Day 70 (end of second intervention period).
|
Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Serum serotonin concentration
Időkeret: Baseline, end of Period 1 (Day 28), end of washout (Day 42), and end of Period 2 (Day 70)
|
Serum serotonin levels will be measured from blood samples to assess systemic neuroactive changes.
|
Baseline, end of Period 1 (Day 28), end of washout (Day 42), and end of Period 2 (Day 70)
|
|
Serum brain-derived neurotrophic factor (BDNF)
Időkeret: Baseline, end of Period 1 (Day 28), end of washout (Day 42), and end of Period 2 (Day 70)
|
Serum BDNF levels measured as a marker of neurotrophic activity and brain-gut axis signalling.
|
Baseline, end of Period 1 (Day 28), end of washout (Day 42), and end of Period 2 (Day 70)
|
|
Inflammatory cytokine (IL-6) concentration
Időkeret: Baseline, end of Period 1 (Day 28), end of washout (Day 42), and end of Period 2 (Day 70)
|
Plasma concentrations of IL-6 will be measured as indicators of systemic inflammatory and anti-inflammatory responses.
|
Baseline, end of Period 1 (Day 28), end of washout (Day 42), and end of Period 2 (Day 70)
|
|
Inflammatory cytokine (IL-10) concentration
Időkeret: Baseline, end of Period 1 (Day 28), end of washout (Day 42), and end of Period 2 (Day 70)
|
Plasma concentrations IL-10 will be measured as indicators of systemic inflammatory and anti-inflammatory responses.
|
Baseline, end of Period 1 (Day 28), end of washout (Day 42), and end of Period 2 (Day 70)
|
|
Inflammatory cytokine (TNF-alpha)
Időkeret: Baseline, end of Period 1 (Day 28), end of washout (Day 42), and end of Period 2 (Day 70)
|
Plasma concentrations TNF-α will be measured as indicators of systemic inflammatory and anti-inflammatory responses.
|
Baseline, end of Period 1 (Day 28), end of washout (Day 42), and end of Period 2 (Day 70)
|
|
Intestinal fatty acid-binding protein (I-FABP)
Időkeret: Baseline, end of Period 1 (Day 28), end of washout (Day 42), and end of Period 2 (Day 70)
|
Plasma I-FABP levels will be measured as a marker of intestinal epithelial integrity and permeability.
|
Baseline, end of Period 1 (Day 28), end of washout (Day 42), and end of Period 2 (Day 70)
|
Együttműködők és nyomozók
Szponzor
Publikációk és hasznos linkek
Általános kiadványok
- World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA. 2013 Nov 27;310(20):2191-4. doi: 10.1001/jama.2013.281053. No abstract available.
- Wickens KL, Barthow CA, Murphy R, Abels PR, Maude RM, Stone PR, Mitchell EA, Stanley TV, Purdie GL, Kang JM, Hood FE, Rowden JL, Barnes PK, Fitzharris PF, Crane J. Early pregnancy probiotic supplementation with Lactobacillus rhamnosus HN001 may reduce the prevalence of gestational diabetes mellitus: a randomised controlled trial. Br J Nutr. 2017 Mar;117(6):804-813. doi: 10.1017/S0007114517000289. Epub 2017 Apr 3.
- Zhou JS, Shu Q, Rutherfurd KJ, Prasad J, Gopal PK, Gill HS. Acute oral toxicity and bacterial translocation studies on potentially probiotic strains of lactic acid bacteria. Food Chem Toxicol. 2000 Feb-Mar;38(2-3):153-61. doi: 10.1016/s0278-6915(99)00154-4.
- Zhou JS, Pillidge CJ, Gopal PK, Gill HS. Antibiotic susceptibility profiles of new probiotic Lactobacillus and Bifidobacterium strains. Int J Food Microbiol. 2005 Feb 1;98(2):211-7. doi: 10.1016/j.ijfoodmicro.2004.05.011.
- Zahr NM, Mayer D, Pfefferbaum A, Sullivan EV. Low striatal glutamate levels underlie cognitive decline in the elderly: evidence from in vivo molecular spectroscopy. Cereb Cortex. 2008 Oct;18(10):2241-50. doi: 10.1093/cercor/bhm250. Epub 2008 Jan 29.
- Yao M, Xie J, Du H, McClements DJ, Xiao H, Li L. Progress in microencapsulation of probiotics: A review. Compr Rev Food Sci Food Saf. 2020 Mar;19(2):857-874. doi: 10.1111/1541-4337.12532. Epub 2020 Feb 11.
- Wu D, Lewis ED, Pae M, Meydani SN. Nutritional Modulation of Immune Function: Analysis of Evidence, Mechanisms, and Clinical Relevance. Front Immunol. 2019 Jan 15;9:3160. doi: 10.3389/fimmu.2018.03160. eCollection 2018.
- Rode J, Edebol Carlman HMT, Konig J, Repsilber D, Hutchinson AN, Thunberg P, Andersson P, Persson J, Kiselev A, Lathrop Stern L, Salomon B, Mohammed AA, Labus JS, Brummer RJ. Probiotic Mixture Containing Lactobacillus helveticus, Bifidobacterium longum and Lactiplantibacillus plantarum Affects Brain Responses Toward an Emotional Task in Healthy Subjects: A Randomized Clinical Trial. Front Nutr. 2022 Apr 29;9:827182. doi: 10.3389/fnut.2022.827182. eCollection 2022.
- Moro-Garcia MA, Alonso-Arias R, Baltadjieva M, Fernandez Benitez C, Fernandez Barrial MA, Diaz Ruisanchez E, Alonso Santos R, Alvarez Sanchez M, Saavedra Mijan J, Lopez-Larrea C. Oral supplementation with Lactobacillus delbrueckii subsp. bulgaricus 8481 enhances systemic immunity in elderly subjects. Age (Dordr). 2013 Aug;35(4):1311-26. doi: 10.1007/s11357-012-9434-6. Epub 2012 May 30.
- Hutchinson AN, Bergh C, Kruger K, Susserova M, Allen J, Ameen S, Tingo L. The Effect of Probiotics on Health Outcomes in the Elderly: A Systematic Review of Randomized, Placebo-Controlled Studies. Microorganisms. 2021 Jun 21;9(6):1344. doi: 10.3390/microorganisms9061344.
- Gbassi GK, Vandamme T. Probiotic encapsulation technology: from microencapsulation to release into the gut. Pharmaceutics. 2012 Feb 6;4(1):149-63. doi: 10.3390/pharmaceutics4010149.
- Costabile A, Bergillos-Meca T, Rasinkangas P, Korpela K, de Vos WM, Gibson GR. Effects of Soluble Corn Fiber Alone or in Synbiotic Combination with Lactobacillus rhamnosus GG and the Pilus-Deficient Derivative GG-PB12 on Fecal Microbiota, Metabolism, and Markers of Immune Function: A Randomized, Double-Blind, Placebo-Controlled, Crossover Study in Healthy Elderly (Saimes Study). Front Immunol. 2017 Dec 12;8:1443. doi: 10.3389/fimmu.2017.01443. eCollection 2017.
- Anderson LA, Goodman RA, Holtzman D, Posner SF, Northridge ME. Aging in the United States: opportunities and challenges for public health. Am J Public Health. 2012 Mar;102(3):393-5. doi: 10.2105/AJPH.2011.300617. Epub 2012 Jan 19. No abstract available.
- Bagga D, Aigner CS, Reichert JL, Cecchetto C, Fischmeister FPS, Holzer P, Moissl-Eichinger C, Schopf V. Influence of 4-week multi-strain probiotic administration on resting-state functional connectivity in healthy volunteers. Eur J Nutr. 2019 Aug;58(5):1821-1827. doi: 10.1007/s00394-018-1732-z. Epub 2018 May 30.
- Stewart DA, Burns JM, Beard K, Dall JL, Lennox IM, Roberts MA, Macfarlane GJ. The roles of general and geriatric medicine in the provision of acute medical care for elderly patients. Health Bull (Edinb). 1992 May;50(3):259-66.
- Altamirano-Rios AV, Guadarrama-Lezama AY, Arroyo-Maya IJ, Hernandez-Alvarez A, Orozco-Villafuerte J. Effect of encapsulation methods and materials on the survival and viability of Lactobacillus acidophilus: A review. Int J Food Sci Tech. 2022 Apr; 57(7):15779.
Hasznos linkek
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
Elsődleges befejezés (Becsült)
A tanulmány befejezése (Becsült)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- RS24-010
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
Gyógyszer- és eszközinformációk, tanulmányi dokumentumok
Egy amerikai FDA által szabályozott gyógyszerkészítményt tanulmányoz
Egy amerikai FDA által szabályozott eszközterméket tanulmányoz
Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .