Ignite Creation Date:
2024-05-06 @ 1:27 PM
Last Modification Date:
2024-10-26 @ 1:14 PM
Study NCT ID:
NCT04022434
Status:
UNKNOWN
Last Update Posted:
2020-04-15
First Post:
2019-07-15
Brief Title:
Investigation of Supplemental L-alanine in the Management of Dietary Fructose Intolerance
Sponsor:
Augusta University
Organization:
Augusta University
Study Overview
Official Title:
Investigation of Supplemental L-alanine in the Management of Dietary Fructose Intolerance a Double-blind Randomized Study
Status:
UNKNOWN
Status Verified Date:
2019-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Over the past few decades fructose consumption has risen significantly in the United States1 This sugar is increasingly being used as a sweetener in a variety of foods1 Because there is a limited absorptive capacity for fructose excessive ingestion of fructose leads to fructose malabsorption and dietary fructose intolerance DFI 2-9 13 Incomplete absorption of fructose may lead to a variety of gastrointestinal symptoms including bloating pain gas and diarrhea 2-9 In tertiary care centers the prevalence of DFI in subjects with unexplained GI symptoms has been estimated to range between 11-50 when subjects were assessed with breath tests following administration of 25 grams of fructose 2 5-7
Currently the main treatment for DFI consists of restricting the intake of fructose-containing foods 10-12 or limiting the intake of foods with excess free fructose ie fructose in excess of glucose or a high fructan content17 These diet restrictions can improve symptoms in patients with DFI 10-1217 However the diet is very restrictive and imposes a significant burden on the individual and the family In one study 40 of subjects were unable to comply with dietary restrictions 10 Currently there are no other therapeutic agents for treating this condition 14 15 Apart from promoting intestinal fructose absorption an ideal therapeutic agent should be safe simple to use inexpensive and have no calorific value
Fructose is mostly absorbed in the small intestine by facilitated diffusion which is mediated by the GLUT-5 transporter protein This protein is expressed on the intestinal mucosal surface In the presence of glucose fructose absorption is increased mostly due to co-transport with glucose via the GLUT-2 transporter protein However the calorie content of glucose precludes its routine use in patients with DFI Other compounds that promote fructose absorption such as 3 O-methyl glucose and epidermal growth factor EGF have significant side effects and safety issues making them unsuitable for clinical use in DFI
Several amino acids including alanine have been also been shown to increase intestinal fructose absorption 14 The postulated mechanism is as follows transmucosal Na-coupled amino acid transport causes increased water flow through the mucosal apical membrane14 This in turn facilitates fructose absorption by a process of solvent drag caused by an increase in intraluminal fructose concentration caused by water removal from the lumen14 The potential benefit of alanine was assessed in a European study in healthy children 14 Ten subjects underwent H2 breath tests following administration of fructose alone 2g Kg body weight followed by a combination of fructose and an equi-molar dose of various amino acids L-alanine L-phenylalanine L-glutamine L-proline or glucose Breath H2 production was assessed as a marker of intestinal fructose absorption Subjects were asked to report any gastrointestinal symptoms during the test All subjects had a positive 20 ppm of H2 breath test 68 38 ppm with fructose and 610 subjects reported either abdominal pain or diarrhea during the test Co-administration of alanine caused a significant p 005 decrease in breath H2 production 3 3 ppm suggesting increased intestinal fructose absorption Furthermore none of the subjects reported any gastrointestinal symptoms during the test
Currently the main treatment for DFI consists of restricting the intake of fructose-containing foods 10-12 or limiting the intake of foods with excess free fructose ie fructose in excess of glucose or a high fructan content17 These diet restrictions can improve symptoms in patients with DFI 10-1217 However the diet is very restrictive and imposes a significant burden on the individual and the family In one study 40 of subjects were unable to comply with dietary restrictions 10 Currently there are no other therapeutic agents for treating this condition 14 15 Apart from promoting intestinal fructose absorption an ideal therapeutic agent should be safe simple to use inexpensive and have no calorific value
Fructose is mostly absorbed in the small intestine by facilitated diffusion which is mediated by the GLUT-5 transporter protein This protein is expressed on the intestinal mucosal surface In the presence of glucose fructose absorption is increased mostly due to co-transport with glucose via the GLUT-2 transporter protein However the calorie content of glucose precludes its routine use in patients with DFI Other compounds that promote fructose absorption such as 3 O-methyl glucose and epidermal growth factor EGF have significant side effects and safety issues making them unsuitable for clinical use in DFI
Several amino acids including alanine have been also been shown to increase intestinal fructose absorption 14 The postulated mechanism is as follows transmucosal Na-coupled amino acid transport causes increased water flow through the mucosal apical membrane14 This in turn facilitates fructose absorption by a process of solvent drag caused by an increase in intraluminal fructose concentration caused by water removal from the lumen14 The potential benefit of alanine was assessed in a European study in healthy children 14 Ten subjects underwent H2 breath tests following administration of fructose alone 2g Kg body weight followed by a combination of fructose and an equi-molar dose of various amino acids L-alanine L-phenylalanine L-glutamine L-proline or glucose Breath H2 production was assessed as a marker of intestinal fructose absorption Subjects were asked to report any gastrointestinal symptoms during the test All subjects had a positive 20 ppm of H2 breath test 68 38 ppm with fructose and 610 subjects reported either abdominal pain or diarrhea during the test Co-administration of alanine caused a significant p 005 decrease in breath H2 production 3 3 ppm suggesting increased intestinal fructose absorption Furthermore none of the subjects reported any gastrointestinal symptoms during the test
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None