Ignite Creation Date:
2024-05-06 @ 2:02 PM
Last Modification Date:
2024-10-26 @ 1:24 PM
Study NCT ID:
NCT04194255
Status:
COMPLETED
Last Update Posted:
2021-01-22
First Post:
2019-12-09
Brief Title:
The Effect of Different Prebiotics on Iron Absorption From High Dose Iron Supplements
Sponsor:
Swiss Federal Institute of Technology
Organization:
Swiss Federal Institute of Technology
Study Overview
Official Title:
The Effect of Single Dose Oral Galacto-oligosaccharides Fructo-oligosaccharides and Acacia Gum on Iron Absorption From Single 100 mg Oral Iron Doses Given as Ferrous Fumarate in Women Living in Switzerland
Status:
COMPLETED
Status Verified Date:
2021-01
Last Known Status:
None
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:
Iron deficiency ID remains the most common global nutrient deficiency with young women at high risk Iron supplements are first line treatment for ID but absorption is often low Dietary components that could increase iron absorption would be valuable
Prebiotics are among the potential enhancers of non-heme iron absorption Galacto-oligosaccharides GOS fructo-oligosaccharides and acacia gum are safe and widely-used prebiotics
To our knowledge no studies have assessed the effect of acacia gum on iron absorption in human or animal models Evidence exists about the enhancement of iron absorption when given in combination with FOS in rats However an iron stable isotope study in infants reported that 75 g of GOS improved iron absorption from 5 mg iron from a mixture of ferrous fumarate and sodium iron EDTA In a recent iron absorption study in adult women with low iron stores in our lab we found that 15 g of GOS given with FeFum 14 mg of elemental iron acutely increased iron absorption when given with water 61 and a meal 28
For prevention of anemia among non-pregnant women the WHO recommends intermittent once twice or three times a week oral iron supplementation with 60 mg of elemental iron This has been shown to be effective safe and acceptable for improving hemoglobin concentrations in women and lowering their risk of anemia If GOS improves iron absorption from a higher dose of iron and if FOS and acacia gum might also enhance iron absorption from FeFum is unclear With this study we therefore aim to investigate if consumption of a single oral dose of 15 g GOS FOS or acacia gum increase iron absorption from single 100 mg oral iron doses a common amount found in supplements on the market for treatment of iron deficiency given as ferrous fumarate in otherwise healthy iron depleted women
Prebiotics are among the potential enhancers of non-heme iron absorption Galacto-oligosaccharides GOS fructo-oligosaccharides and acacia gum are safe and widely-used prebiotics
To our knowledge no studies have assessed the effect of acacia gum on iron absorption in human or animal models Evidence exists about the enhancement of iron absorption when given in combination with FOS in rats However an iron stable isotope study in infants reported that 75 g of GOS improved iron absorption from 5 mg iron from a mixture of ferrous fumarate and sodium iron EDTA In a recent iron absorption study in adult women with low iron stores in our lab we found that 15 g of GOS given with FeFum 14 mg of elemental iron acutely increased iron absorption when given with water 61 and a meal 28
For prevention of anemia among non-pregnant women the WHO recommends intermittent once twice or three times a week oral iron supplementation with 60 mg of elemental iron This has been shown to be effective safe and acceptable for improving hemoglobin concentrations in women and lowering their risk of anemia If GOS improves iron absorption from a higher dose of iron and if FOS and acacia gum might also enhance iron absorption from FeFum is unclear With this study we therefore aim to investigate if consumption of a single oral dose of 15 g GOS FOS or acacia gum increase iron absorption from single 100 mg oral iron doses a common amount found in supplements on the market for treatment of iron deficiency given as ferrous fumarate in otherwise healthy iron depleted women
Detailed Description:
Prebiotics are defined as microbial food supplements that beneficially affect the host by selectively stimulating the growth andor activity of one or a limited number of bacterial species already resident in the colon Moreover prebiotics are potential enhancers of iron absorption via several mechanisms a increasing gastric residence time allowing for greater iron dissolution b stimulating enterocyte gene expression of proteins involved in iron absorption c stimulating enterocyte proliferation providing a greater surface for iron absorption and d stimulating SCFA production by gut commensal bacteria decreasing distal gut luminal pH and increasing iron dissolution
Galacto-oligosaccharides GOS a safe and widely-used prebiotic are a mixture of glucose- and galactose-based di- and oligosaccharides of varying structure and may be more selectively utilized by Bifidobacterium spp than other prebiotics Fructo-oligosaccharides FOS are composed by 4 to 9 units of fructose alone or in combination with one unit of glucose FOS are widely used as food ingredientsnutritional supplements due to their bifidogenic properties Acacia gum is composed by highly branched galactan polymers with galactose andor arabinose side chains possibly terminated by rhamnose or glucuronic acid residues Both in-vitro and in-vivo studies have shown that acacia gum supports bifidobacterial growth and short-chain fatty acids SCFA production in the large intestine
GOS and FOS have received GRAS status in the USA Acacia gum is extensively used in the food industry for various functions emulsification encapsulation stabilization etc It is affirmed as GRAS for use in various food items Acacia gum in human subjects is well tolerated up to 50 gday The European Food Safety Authority stated that there is no safety concern for the use of Acacia Gum as a food supplement
To our knowledge no studies have assessed the effect of acacia gum on iron absorption in human or animal models Evidence exists about the enhancement of iron absorption when given in combination with FOS in rats In humans studies so far have failed in showing an effect of FOS on iron absorption However an iron stable isotope study in infants reported that 75 g of GOS improved iron absorption from 5 mg iron from a mixture of ferrous fumarate and sodium iron EDTA Moreover in a recent iron absorption study in adult women with low iron stores in our lab we found that 15 g of GOS given with FeFum 14 mg of elemental iron acutely increased iron absorption when given with water 61 and a meal 28 In another study in our lab unpublished data we found that 7 g of GOS given with FeFum 14 mg of elemental iron acutely increased iron absorption when given with water 26 in iron depleted women These effects were found to be iron compound specific and could not be shown for ferrous sulfate the iron compound used in the existing human studies with FOS
For prevention of anemia among non-pregnant women the WHO recommends intermittent once twice or three times a week oral iron supplementation with 60 mg of elemental iron This has been shown to be effective safe and acceptable for improving hemoglobin concentrations in women and lowering their risk of anemia
If GOS improves iron absorption from a higher dose of iron and if FOS and acacia gum might also enhance iron absorption from FeFum is unclear With this study we therefore aim to investigate if consumption of a single oral dose of 15 g GOS FOS or acacia gum increase iron absorption from single 100 mg oral iron doses a common amount found in supplements on the market for treatment of iron deficiency given as ferrous fumarate in otherwise healthy iron depleted women
Galacto-oligosaccharides GOS a safe and widely-used prebiotic are a mixture of glucose- and galactose-based di- and oligosaccharides of varying structure and may be more selectively utilized by Bifidobacterium spp than other prebiotics Fructo-oligosaccharides FOS are composed by 4 to 9 units of fructose alone or in combination with one unit of glucose FOS are widely used as food ingredientsnutritional supplements due to their bifidogenic properties Acacia gum is composed by highly branched galactan polymers with galactose andor arabinose side chains possibly terminated by rhamnose or glucuronic acid residues Both in-vitro and in-vivo studies have shown that acacia gum supports bifidobacterial growth and short-chain fatty acids SCFA production in the large intestine
GOS and FOS have received GRAS status in the USA Acacia gum is extensively used in the food industry for various functions emulsification encapsulation stabilization etc It is affirmed as GRAS for use in various food items Acacia gum in human subjects is well tolerated up to 50 gday The European Food Safety Authority stated that there is no safety concern for the use of Acacia Gum as a food supplement
To our knowledge no studies have assessed the effect of acacia gum on iron absorption in human or animal models Evidence exists about the enhancement of iron absorption when given in combination with FOS in rats In humans studies so far have failed in showing an effect of FOS on iron absorption However an iron stable isotope study in infants reported that 75 g of GOS improved iron absorption from 5 mg iron from a mixture of ferrous fumarate and sodium iron EDTA Moreover in a recent iron absorption study in adult women with low iron stores in our lab we found that 15 g of GOS given with FeFum 14 mg of elemental iron acutely increased iron absorption when given with water 61 and a meal 28 In another study in our lab unpublished data we found that 7 g of GOS given with FeFum 14 mg of elemental iron acutely increased iron absorption when given with water 26 in iron depleted women These effects were found to be iron compound specific and could not be shown for ferrous sulfate the iron compound used in the existing human studies with FOS
For prevention of anemia among non-pregnant women the WHO recommends intermittent once twice or three times a week oral iron supplementation with 60 mg of elemental iron This has been shown to be effective safe and acceptable for improving hemoglobin concentrations in women and lowering their risk of anemia
If GOS improves iron absorption from a higher dose of iron and if FOS and acacia gum might also enhance iron absorption from FeFum is unclear With this study we therefore aim to investigate if consumption of a single oral dose of 15 g GOS FOS or acacia gum increase iron absorption from single 100 mg oral iron doses a common amount found in supplements on the market for treatment of iron deficiency given as ferrous fumarate in otherwise healthy iron depleted women
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