Effect of Polyphenols on Absorption of Iron From Sodium Iron Chlorophyllin

NCT04849832 | Completed

• 1 other identifier: PolySIC
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Polyphenols present in tea are known to inhibit the absorption of non heme iron. The inhibiting effect of tea on non-heme iron absorption is attributed to the flavonoids present in tea. It is well known that Ferrous sulfate is not absorbed well in the presence of polyphenols. We would like to evaluate the effect of polyphenols on the newly developed compound, sodium iron chlorophyllin (SIC), which mimics the heme iron structure. Comparisons of fractional absorption of SIC and Ferrous Sulfate in the presence of polyphenols can help identify the performance of the compounds as vehicles for iron delivery in the presence of iron absorption inhibitors. In a single-blind randomized cross-over study using stable iron isotope technique, iron bioavailability from SIC delivered with an inhibitory matrix can therefore be determined when given along with black tea

Conditions

Iron-deficiency

Outcome Measures

Primary Outcomes (3)

• Ratio of FIA of SIC arms vs ratio of FIA of Ferrous sulfate arms

  ratio of iron bioavailability (as measured by erythrocyte incorporation of the stable isotope labels) from SIC in a polyphenol matrix to that from SIC alone with the ratio of iron bioavailability from FeSO4 in a polyphenol matrix to that from FeSO4 alone.

  Day 1 of the study

• Ratio of FIA of SIC arms vs ratio of FIA of Ferrous sulfate arms

  ratio of iron bioavailability (as measured by erythrocyte incorporation of the stable isotope labels) from SIC in a polyphenol matrix to that from SIC alone with the ratio of iron bioavailability from FeSO4 in a polyphenol matrix to that from FeSO4 alone.

  Day 17 of the study

• Ratio of FIA of SIC arms vs ratio of FIA of Ferrous sulfate arms

  ratio of iron bioavailability (as measured by erythrocyte incorporation of the stable isotope labels) from SIC in a polyphenol matrix to that from SIC alone with the ratio of iron bioavailability from FeSO4 in a polyphenol matrix to that from FeSO4 alone.

  Day 33 of the study

Secondary Outcomes (4)

• Hemoglobin

  day 1, day 17 and day 33 of the the study

• Ferritin

  day 1, day 17 and day 33 of the the study

• sTfR

  day 1, day 17 and day 33 of the the study

• C-reactive Protein

  day 1, day 17 and day 33 of the the study

Study Arms (4)

SIC

EXPERIMENTAL

4mg of Fe will be given as 102 mg of SIC as a solution

Dietary Supplement: SIC

SIC + tea

EXPERIMENTAL

4 mg of Fe will be given as 102 mg of SIC as a solution along with 200 ml of black tea

Dietary Supplement: SIC + tea

FeSO4

ACTIVE COMPARATOR

4 mg of Fe will be given as Ferrous sulfate solution

Dietary Supplement: FeSO4

FeSO4 + tea

ACTIVE COMPARATOR

4 mg of Fe will be given as Ferrous sulfate solution along with 200 ml of black tea

Dietary Supplement: FeSO4 + tea

Interventions

SIC DIETARY_SUPPLEMENT

Sodium Iron Chlorophyllin as prepared by the human nutrition laboratory, ETH Zurich

SIC

SIC + tea DIETARY_SUPPLEMENT

Sodium Iron Chlorophyllin as prepared by the human nutrition laboratory, ETH Zurich with 2g of tea brewed for 5 minutes

SIC + tea

FeSO4 DIETARY_SUPPLEMENT

Ferrous sulfate solution serves as a positive control - and whose absorption is well known.

FeSO4

FeSO4 + tea DIETARY_SUPPLEMENT

Ferrous sulfate solution given with 2g of tea brewed for 5 minutes - expected iron absorption inhibition

FeSO4 + tea

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Only females
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• female aged between 18-45 y old;
• SF \<80 µg/L;
• BMI 18.5-24.9 kg/m2;
• weight \<70 kg;
• signed informed consent;
• able to communicate and comprehend English language.

You may not qualify if:

• anemia (Hb \<12 g/dL);
• Inflammation (CRP \> 5 mg/L);
• chronic digestive, renal and/or metabolic disease;
• chronic medications (except for oral contraceptives);
• use of vitamin, mineral and pre- and/or probiotic supplements in the previous 2 weeks before study initiation and during the course of the study;
• blood transfusion, blood donation or significant blood loss over the past 4 months;
• difficulties with blood sampling;
• antibiotic treatment in the 4 weeks before study initiation;
• pregnancy (tested in serum at screening) or intention to become pregnant;
• lactation up to 6 weeks before study initiation;
• earlier participation in a study using stable isotopes or participation in any clinical study within the last 30 days;
• unable to comply with study protocol (e.g. not available on certain study appointment days or difficulties with blood withdrawal);
• inability to understand the information sheet and the informed consent form due to cognitive or language reasons;
• smoking;
• unwilling to use an effective method of contraception.

Sponsors & Collaborators

• Swiss Federal Institute of Technology: lead

Study Sites (1)

ETH Zürich, Laboratory of Human Nutrition

Zurich, Canton of Zurich, 8092, Switzerland

Location

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Interventions

Tea

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Plant Preparations; Biological Products; Complex Mixtures; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Jessica Farebrother, Dr.Sc

  ETH Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: There will be no masking as the ferrous sulfate solutions will be colourless compared to the green color solution of SIC
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study will be a randomized, single centre cross over study where every participant will receive all the four interventions.

Study Record Dates

• First Submitted: April 15, 2021
• First Posted: April 19, 2021
• Study Start: June 21, 2021
• Primary Completion: July 26, 2021
• Study Completion: July 26, 2021
• Last Updated: November 26, 2021

Record last verified: 2021-11

Locations

CH (1)