Determination of Iron Absorption Mechanism From Ferrous Fumarate With GOS

Low Iron Stores Clinical Trial

— Fe_GOS_3  

Official title:

Determination of Iron Absorption Mechanism From Ferrous Fumarate With Galacto-oligosaccharides Using Stable Isotope Appearance Curves

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03996421
• Other study ID #: Fe_GOS_3
• Status: Completed
• Phase: N/A
• Start date: October 23, 2019
• Est. completion date: November 27, 2019

Study information

• Verified date: December 2019
• Source: Swiss Federal Institute of Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim is to investigate the mechanism by which galacto-oligosaccharide acutely increases iron absorption by using stable isotope appearance curves. This will allow the evaluation of changes in serum iron isotopes over the first few hours after administration of the iron supplement and provides information where and in what amount iron absorption takes place in the GI-tract.

Description:

Iron is an important mineral in our body and fulfills essential functions such as for example oxygen transport from the lungs to the tissues. Iron deficiency is still the most common and widespread nutritional disorder in the world according to WHO. Common iron supplements all have their limitations in terms of availability and compatibility. Prebiotic fibers, such as galacto-oligosaccharides (GOS), selectively enhance growth of beneficial colonic bacteria. Prebiotics in general enhance the production of short-chain fatty acids (SCFAs) and thereby decrease luminal pH. Through the reduction in pH, prebiotics can enhance absorption of minerals such as calcium and magnesium and they have been proposed to potentially improve iron absorption.

In a recent iron absorption study in adult women with low iron stores in the laboratory of human nutrition ETH zurich, it was found that 15 g of GOS given with an iron supplement in the form of iron fumarate acutely increased iron absorption when given with water and a bread based meal. The dose of 15 g of GOS was tolerated well by the participants. As a follow up to the study, the aim of the current study is to investigate the mechanism by which GOS acutely increases iron absorption by using stable isotope appearance curves. This will allow the evaluation of changes in serum iron isotopes over the first few hours after administration of the iron supplement and provides information where and in what amount iron absorption takes place in the GI-tract.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: November 27, 2019
• Est. primary completion date: November 27, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Female, 18 to 45 years old

• SF levels 15-30 µg/L

• Normal body Mass Index (18.5-24.9 kg/m2)

• Body weight <70 kg

• Signed informed consent

Exclusion Criteria:

• Severe anaemia (Hb < 80 g/L)

• Elevated CRP >10.0 mg/L

• Any metabolic, gastrointestinal kidney or chronic disease such as diabetes, renal failure, hepatic dysfunction, hepatitis, hypertension, cancer or cardiovascular diseases (according to the participants own statement)

• Continuous/long-term use of medication during the whole studies (except for contraceptives)

• Consumption of mineral and vitamin supplements within 2 weeks prior to 1st supplement administration, including pre- and-or probiotics supplements (excluding foods and beverages with life cultures such as yoghurt, raw milk cheese and kombucha)

• Blood transfusion, blood donation or significant blood loss (accident, surgery) over the past 4 months

• Difficulties with blood sampling

• Use of antibiotics over the past month

• Known hypersensitivity to iron supplements in the given amount, GOS, or lactose

• Women who are pregnant or breast feeding

• Women who intend become pregnant during the course of the study

• Lack of safe contraception, defined as: Female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, inject-able, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases

• Known or suspected non-compliance, drug or alcohol (more than 2 drinks/day) abuse -

• Smokers (> 1 cigarette per week)

• Inability to follow the procedures of the study, e.g. due to language problems, self-- reported psychological disorders, etc. of the participant

• Enrollment of the investigator, his/her family members, employees and other dependent persons

Related Conditions & MeSH terms

• Low Iron Stores

Intervention

Dietary Supplement:
• nutritional iron (14 mg) supplement in form of ferrous fumarate
nutritional iron (14 mg) supplement in form of ferrous fumarate
• ferrous fumarate + 15 g GOS
nutritional iron (14 mg) supplement in form of ferrous fumarate with addition of prebiotics (15 g GOS)

Locations

Country	Name	City	State
Switzerland	Laboratory of Human Nutrition, ETH Zurich	Zurich

Sponsors (2)

Lead Sponsor	Collaborator
Isabelle Herter-Aeberli	Antistress AG, Gesellschaft für Gesundheitsschutz - Burgerstein Vitamine

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

Jeroense FMD, Michel L, Zeder C, Herter-Aeberli I, Zimmermann MB. Consumption of Galacto-Oligosaccharides Increases Iron Absorption from Ferrous Fumarate: A Stable Iron Isotope Study in Iron-Depleted Young Women. J Nutr. 2019 May 1;149(5):738-746. doi: 10.1093/jn/nxy327. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serum iron isotope concentration	serum iron isotope concentration from ferrous fumarate with or without the addition of GOS at all the different time points. Serum iron isotope concentration absorbed from the iron supplements will be calculated based on the shift of the iron isotope ratios in the collected blood samples at least 14 days after the last administration of the isotopically labelled supplements.The iron isotope ratios in the collected blood samples will be measured using an ICP-mass spectrometry instrument (NEPTUNE, Thermo Finnigan).	29 days
Primary	total fractional iron absorption	total iron fractional absorption from ferrous fumarate with or without the addition of GOS at all the different time points. Fractional absorption of iron (%) from the iron supplements will be calculated based on the shift of the iron isotope ratios in the collected blood samples at least 14 days after the last administration of the isotopically labelled supplements.The iron isotope ratios in the collected blood samples will be measured using an ICP-mass spectrometry instrument (NEPTUNE, Thermo Finnigan).	29 days
Secondary	Haemoglobin (Hb)	Haemoglobin (Hb) (g/L)	29 days
Secondary	serum ferritin (SF)	serum ferritin (SF) (microg/L)	29 days
Secondary	serum transferrin receptor (sTfR)	serum transferrin receptor (sTfR) (mg)L)	29 days
Secondary	alpha-1-acid glycoprotein (AGP)	alpha-1-acid glycoprotein (AGP) (g/L)	29 days
Secondary	C - reactive protein (CRP)	C - reactive protein (CRP) (mg/L)	29 days