Investigation of the tolerability and potential health benefits of a novel butyrate generating supplement in a pilot human study

BACKGROUND: Butyrate is a health promoting short-chain fatty acid (SCFA) metabolite of fiber fermentation in the gut. Supplementing directly with a butyrate generator may be a dietary alternative with health benefits. OBJECTIVE: To evaluate the effect of tributyrin, a butyrate generator, on tolerabi...

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Veröffentlicht in:Nutrition and healthy aging 2024-10, Vol.9 (1), p.133-144
Hauptverfasser: Smith, Morganne, Lelah, Michael, Goggans, Mallory, Tunio, Sameer, Naqib, Ankur, Burton-Freeman, Britt, Edirisinghe, Indika
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container_end_page 144
container_issue 1
container_start_page 133
container_title Nutrition and healthy aging
container_volume 9
creator Smith, Morganne
Lelah, Michael
Goggans, Mallory
Tunio, Sameer
Naqib, Ankur
Burton-Freeman, Britt
Edirisinghe, Indika
description BACKGROUND: Butyrate is a health promoting short-chain fatty acid (SCFA) metabolite of fiber fermentation in the gut. Supplementing directly with a butyrate generator may be a dietary alternative with health benefits. OBJECTIVE: To evaluate the effect of tributyrin, a butyrate generator, on tolerability, gut microbiome composition, gut permeability, inflammation and metabolic markers in healthy adults at two dose levels. METHODS: Healthy adults (n = 29) were randomized to this single-blinded, two-arm, 28-day parallel design pilot study. Participants ingested one or two placebo capsules for 7 days followed by one or two (200 or 400 mg, respectively) ButyraGen® capsules, a novel tributyrin complex, daily for 21 days. Tolerability was assessed weekly by questionnaire. Blood and stool were collected at baseline and weekly for metabolic and inflammation markers, gut microbiome composition and SCFA concentrations, respectively. Urine was collected at baseline and end of the study for permeability assays. RESULTS: Twenty-four participants (n = 24, 25±8 years; 24.0±2.8 kg/m2; 66% male) completed the study. ButyraGen® was well-tolerated, with less than 10% (n = 2) reporting gastrointestinal-related discomfort. Fecal acetic (p = 0.03) and propionic (p = 0.03) acids decreased after supplementation (p = 0.03 and p = 0.03, respectively, n = 24) compared to baseline, and triglycerides increased (p = 0.02, 400 mg only, n = 11). Trends in decreased hs-CRP after 200 mg (p = 0.08) and 400 mg (p = 0.07) supplementation and decreased glucose (p = 0.10) after 200 mg supplementation was observed. No other changes in endpoints were observed. CONCLUSIONS: Tributyrin supplementation using ButyraGen® was safe and tolerable at the doses provided. Biological effects were observed suggesting butyrate generation and absorption in the small intestine followed by activity in the liver, though further investigation on mechanism of action is needed for confirmation.
doi_str_mv 10.3233/NHA-240005
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Supplementing directly with a butyrate generator may be a dietary alternative with health benefits. OBJECTIVE: To evaluate the effect of tributyrin, a butyrate generator, on tolerability, gut microbiome composition, gut permeability, inflammation and metabolic markers in healthy adults at two dose levels. METHODS: Healthy adults (n = 29) were randomized to this single-blinded, two-arm, 28-day parallel design pilot study. Participants ingested one or two placebo capsules for 7 days followed by one or two (200 or 400 mg, respectively) ButyraGen® capsules, a novel tributyrin complex, daily for 21 days. Tolerability was assessed weekly by questionnaire. Blood and stool were collected at baseline and weekly for metabolic and inflammation markers, gut microbiome composition and SCFA concentrations, respectively. Urine was collected at baseline and end of the study for permeability assays. RESULTS: Twenty-four participants (n = 24, 25±8 years; 24.0±2.8 kg/m2; 66% male) completed the study. ButyraGen® was well-tolerated, with less than 10% (n = 2) reporting gastrointestinal-related discomfort. Fecal acetic (p = 0.03) and propionic (p = 0.03) acids decreased after supplementation (p = 0.03 and p = 0.03, respectively, n = 24) compared to baseline, and triglycerides increased (p = 0.02, 400 mg only, n = 11). Trends in decreased hs-CRP after 200 mg (p = 0.08) and 400 mg (p = 0.07) supplementation and decreased glucose (p = 0.10) after 200 mg supplementation was observed. No other changes in endpoints were observed. CONCLUSIONS: Tributyrin supplementation using ButyraGen® was safe and tolerable at the doses provided. Biological effects were observed suggesting butyrate generation and absorption in the small intestine followed by activity in the liver, though further investigation on mechanism of action is needed for confirmation.</description><identifier>ISSN: 2451-9480</identifier><identifier>EISSN: 2451-9502</identifier><identifier>DOI: 10.3233/NHA-240005</identifier><language>eng</language><publisher>London, England: SAGE Publications</publisher><subject>Adults ; Biological activity ; Biological effects ; Dietary supplements ; Digestive system ; Feces ; Fermentation ; Gastrointestinal tract ; Health promotion ; Inflammation ; Intestinal microflora ; Intestine ; Metabolism ; Metabolites ; Microbiomes ; Permeability ; Small intestine ; Triglycerides</subject><ispartof>Nutrition and healthy aging, 2024-10, Vol.9 (1), p.133-144</ispartof><rights>2024 – The authors. Published by IOS Press</rights><rights>Copyright IOS Press BV 2024</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c1315-2777c824eb6ef4e7a718f17a57ac1a85da3c001986e88f4cc0c6708720419c203</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,777,781,861,27905,27906</link.rule.ids></links><search><creatorcontrib>Smith, Morganne</creatorcontrib><creatorcontrib>Lelah, Michael</creatorcontrib><creatorcontrib>Goggans, Mallory</creatorcontrib><creatorcontrib>Tunio, Sameer</creatorcontrib><creatorcontrib>Naqib, Ankur</creatorcontrib><creatorcontrib>Burton-Freeman, Britt</creatorcontrib><creatorcontrib>Edirisinghe, Indika</creatorcontrib><title>Investigation of the tolerability and potential health benefits of a novel butyrate generating supplement in a pilot human study</title><title>Nutrition and healthy aging</title><description>BACKGROUND: Butyrate is a health promoting short-chain fatty acid (SCFA) metabolite of fiber fermentation in the gut. Supplementing directly with a butyrate generator may be a dietary alternative with health benefits. OBJECTIVE: To evaluate the effect of tributyrin, a butyrate generator, on tolerability, gut microbiome composition, gut permeability, inflammation and metabolic markers in healthy adults at two dose levels. METHODS: Healthy adults (n = 29) were randomized to this single-blinded, two-arm, 28-day parallel design pilot study. Participants ingested one or two placebo capsules for 7 days followed by one or two (200 or 400 mg, respectively) ButyraGen® capsules, a novel tributyrin complex, daily for 21 days. Tolerability was assessed weekly by questionnaire. Blood and stool were collected at baseline and weekly for metabolic and inflammation markers, gut microbiome composition and SCFA concentrations, respectively. Urine was collected at baseline and end of the study for permeability assays. RESULTS: Twenty-four participants (n = 24, 25±8 years; 24.0±2.8 kg/m2; 66% male) completed the study. ButyraGen® was well-tolerated, with less than 10% (n = 2) reporting gastrointestinal-related discomfort. Fecal acetic (p = 0.03) and propionic (p = 0.03) acids decreased after supplementation (p = 0.03 and p = 0.03, respectively, n = 24) compared to baseline, and triglycerides increased (p = 0.02, 400 mg only, n = 11). Trends in decreased hs-CRP after 200 mg (p = 0.08) and 400 mg (p = 0.07) supplementation and decreased glucose (p = 0.10) after 200 mg supplementation was observed. No other changes in endpoints were observed. CONCLUSIONS: Tributyrin supplementation using ButyraGen® was safe and tolerable at the doses provided. Biological effects were observed suggesting butyrate generation and absorption in the small intestine followed by activity in the liver, though further investigation on mechanism of action is needed for confirmation.</description><subject>Adults</subject><subject>Biological activity</subject><subject>Biological effects</subject><subject>Dietary supplements</subject><subject>Digestive system</subject><subject>Feces</subject><subject>Fermentation</subject><subject>Gastrointestinal tract</subject><subject>Health promotion</subject><subject>Inflammation</subject><subject>Intestinal microflora</subject><subject>Intestine</subject><subject>Metabolism</subject><subject>Metabolites</subject><subject>Microbiomes</subject><subject>Permeability</subject><subject>Small intestine</subject><subject>Triglycerides</subject><issn>2451-9480</issn><issn>2451-9502</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2024</creationdate><recordtype>article</recordtype><sourceid>AFRWT</sourceid><recordid>eNptkMFLwzAUxoMoOOYu_gUBD4JQTdJmSY9jqBOGXvRc0uy1zeiS2qSD3vzTzajixdP74P2-9_g-hK4puU9Zmj68blYJywgh_AzNWMZpknPCzn91JsklWni_jwQVnHPCZ-jrxR7BB1OrYJzFrsKhARxcC70qTWvCiJXd4c4FsMGoFjeg2tDgEixUJviTQ2HrjtDicghjrwLgOi6jMLbGfui6Fg7RjI2NZGdaF3AzHJTFPgy78QpdVKr1sPiZc_Tx9Pi-3iTbt-eX9WqbaJpSnjAhhJYsg3IJVQZCCSorKhQXSlMl-U6lOsbK5RKkrDKtiV4KIgUjGc01I-kc3Ux3u959DjFysXdDb-PLIqWUsJxLKSN1N1G6d973UBVdbw6qHwtKilPJRSy5mEqO8O0Ee1XD37l_yG_nMXwC</recordid><startdate>20241018</startdate><enddate>20241018</enddate><creator>Smith, Morganne</creator><creator>Lelah, Michael</creator><creator>Goggans, Mallory</creator><creator>Tunio, Sameer</creator><creator>Naqib, Ankur</creator><creator>Burton-Freeman, Britt</creator><creator>Edirisinghe, Indika</creator><general>SAGE Publications</general><general>IOS Press BV</general><scope>AFRWT</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7QP</scope><scope>7QR</scope><scope>7T7</scope><scope>7TK</scope><scope>8FD</scope><scope>C1K</scope><scope>FR3</scope><scope>P64</scope></search><sort><creationdate>20241018</creationdate><title>Investigation of the tolerability and potential health benefits of a novel butyrate generating supplement in a pilot human study</title><author>Smith, Morganne ; 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Calcified Tissue Abstracts</collection><collection>Chemoreception Abstracts</collection><collection>Industrial and Applied Microbiology Abstracts (Microbiology A)</collection><collection>Neurosciences Abstracts</collection><collection>Technology Research Database</collection><collection>Environmental Sciences and Pollution Management</collection><collection>Engineering Research Database</collection><collection>Biotechnology and BioEngineering Abstracts</collection><jtitle>Nutrition and healthy aging</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Smith, Morganne</au><au>Lelah, Michael</au><au>Goggans, Mallory</au><au>Tunio, Sameer</au><au>Naqib, Ankur</au><au>Burton-Freeman, Britt</au><au>Edirisinghe, Indika</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Investigation of the tolerability and potential health benefits of a novel butyrate generating supplement in a pilot human study</atitle><jtitle>Nutrition and healthy aging</jtitle><date>2024-10-18</date><risdate>2024</risdate><volume>9</volume><issue>1</issue><spage>133</spage><epage>144</epage><pages>133-144</pages><issn>2451-9480</issn><eissn>2451-9502</eissn><abstract>BACKGROUND: Butyrate is a health promoting short-chain fatty acid (SCFA) metabolite of fiber fermentation in the gut. Supplementing directly with a butyrate generator may be a dietary alternative with health benefits. OBJECTIVE: To evaluate the effect of tributyrin, a butyrate generator, on tolerability, gut microbiome composition, gut permeability, inflammation and metabolic markers in healthy adults at two dose levels. METHODS: Healthy adults (n = 29) were randomized to this single-blinded, two-arm, 28-day parallel design pilot study. Participants ingested one or two placebo capsules for 7 days followed by one or two (200 or 400 mg, respectively) ButyraGen® capsules, a novel tributyrin complex, daily for 21 days. Tolerability was assessed weekly by questionnaire. Blood and stool were collected at baseline and weekly for metabolic and inflammation markers, gut microbiome composition and SCFA concentrations, respectively. Urine was collected at baseline and end of the study for permeability assays. RESULTS: Twenty-four participants (n = 24, 25±8 years; 24.0±2.8 kg/m2; 66% male) completed the study. ButyraGen® was well-tolerated, with less than 10% (n = 2) reporting gastrointestinal-related discomfort. Fecal acetic (p = 0.03) and propionic (p = 0.03) acids decreased after supplementation (p = 0.03 and p = 0.03, respectively, n = 24) compared to baseline, and triglycerides increased (p = 0.02, 400 mg only, n = 11). Trends in decreased hs-CRP after 200 mg (p = 0.08) and 400 mg (p = 0.07) supplementation and decreased glucose (p = 0.10) after 200 mg supplementation was observed. No other changes in endpoints were observed. CONCLUSIONS: Tributyrin supplementation using ButyraGen® was safe and tolerable at the doses provided. Biological effects were observed suggesting butyrate generation and absorption in the small intestine followed by activity in the liver, though further investigation on mechanism of action is needed for confirmation.</abstract><cop>London, England</cop><pub>SAGE Publications</pub><doi>10.3233/NHA-240005</doi><tpages>12</tpages><oa>free_for_read</oa></addata></record>
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subjects Adults
Biological activity
Biological effects
Dietary supplements
Digestive system
Feces
Fermentation
Gastrointestinal tract
Health promotion
Inflammation
Intestinal microflora
Intestine
Metabolism
Metabolites
Microbiomes
Permeability
Small intestine
Triglycerides
title Investigation of the tolerability and potential health benefits of a novel butyrate generating supplement in a pilot human study
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