Iron & Alginate Study

NCT01528644 | Completed

• 2 other identifiers: BBSRC grant:BB/G0055833/12011/2012-05
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

Iron deficiency anaemia affects around two billion people worldwide. Food fortification with iron is a realistic way to combat this problem. Water soluble forms of iron are considered to be more bioavailable than nonsoluble iron compounds. However, the former often cause sensory problems when added to foods, while the latter cause fewer problems but are not generally well absorbed and are therefore ineffective as fortificants. A potential strategy for overcoming this problem is the use of water soluble iron compounds protected by a water resistant barrier, which will prevent potential organoleptic changes within fortified foods and protect the iron (from oxidation) through the digestion process thus increasing its availability. The investigators will use alginate, in the form of alginate beads, as a protective barrier for soluble iron gluconate. It has been shown that alginates bind divalent and trivalent cations and therefore may be a useful vehicle for soluble iron compounds to fortify foods. The aim of this project is to measure the effect of alginate on iron absorption from ferrous gluconate and assess the potential modulating effect of calcium on iron absorption in the presence and absence of alginate.

Conditions

Iron Deficiency; Anaemia

Keywords

iron; fortification; alginate; iron deficiency

Outcome Measures

Primary Outcomes (1)

• Change in iron absorption

  Iron absorption (by measuring iron appearance in the serum)will be measured on four occasions with a week in between each measurement. Absorption will be assessed in response to four test meals as follows: unprotected ferrous gluconate, iron gluconate incorporated into alginate beads,ferrous gluconate incorporated into alginate beads given with calcium, and unprotected ferrous gluconate given with calcium.

  Four weekly measurements over a period of three weeks (6h Cannulation, baseline blood sample (t=0). Test meal 1, followed by blood sample collection at 20, 40, 60, 80, 100, 120, 150, 180, 240, 300 and 360 min. Removal of the cannula)

Study Arms (4)

Iron in beads

EXPERIMENTAL

All experimental days will be exactly the same with the exception of the test meal administered to the volunteer. Volunteers will undergo a 10 hour overnight fast from 10:00pm, then they will be asked to attend the CRTU at approximately 8:00 am the following morning. A nurse will take and record the volunteer's blood pressure and if within the range an intravenous (i.v.) cannula will be inserted into a vein in one of the volunteer's arms. The cannula will remain in situ for six hours. After the first blood sample (t=0) will be taken, volunteers will consume one out of 4 test meals. After consumption further blood samples will be collected at: 20, 40, 60, 80, 100, 120, 150, 180, 240, 300 and 360 min. Blood samples will subsequently be analysed for serum iron concentrations.

Dietary Supplement: alginate beads containing ferrous gluconate

Iron in capsule

EXPERIMENTAL

All experimental days will be exactly the same with the exception of the test meal administered to the volunteer. Volunteers will undergo a 10 hour overnight fast from 10:00pm, then they will be asked to attend the CRTU at approximately 8:00 am the following morning. A nurse will take and record the volunteer's blood pressure and if within the range an intravenous (i.v.) cannula will be inserted into a vein in one of the volunteer's arms. The cannula will remain in situ for six hours. After the first blood sample (t=0) will be taken, volunteers will consume one out of 4 test meals. After consumption further blood samples will be collected at: 20, 40, 60, 80, 100, 120, 150, 180, 240, 300 and 360 min. Blood samples will subsequently be analysed for serum iron concentrations.

Dietary Supplement: ferrous gluconate in a capsule

Iron in beads in presence of calcium

EXPERIMENTAL

All experimental days will be exactly the same with the exception of the test meal administered to the volunteer. Volunteers will undergo a 10 hour overnight fast from 10:00pm, then they will be asked to attend the CRTU at approximately 8:00 am the following morning. A nurse will take and record the volunteer's blood pressure and if within the range an intravenous (i.v.) cannula will be inserted into a vein in one of the volunteer's arms. The cannula will remain in situ for six hours. After the first blood sample (t=0) will be taken, volunteers will consume one out of 4 test meals. After consumption further blood samples will be collected at: 20, 40, 60, 80, 100, 120, 150, 180, 240, 300 and 360 min. Blood samples will subsequently be analysed for serum iron concentrations.

Dietary Supplement: alginate beads with ferrous gluconate in presence of calcium

Iron in capsule in presence of calcium

EXPERIMENTAL

All experimental days will be exactly the same with the exception of the test meal administered to the volunteer. Volunteers will undergo a 10 hour overnight fast from 10:00pm, then they will be asked to attend the CRTU at approximately 8:00 am the following morning. A nurse will take and record the volunteer's blood pressure and if within the range an intravenous (i.v.) cannula will be inserted into a vein in one of the volunteer's arms. The cannula will remain in situ for six hours. After the first blood sample (t=0) will be taken, volunteers will consume one out of 4 test meals. After consumption further blood samples will be collected at: 20, 40, 60, 80, 100, 120, 150, 180, 240, 300 and 360 min. Blood samples will subsequently be analysed for serum iron concentrations.

Dietary Supplement: ferrous gluconate in a capsule in presence of calcium

Interventions

alginate beads containing ferrous gluconate DIETARY_SUPPLEMENT

After insertion of the cannula and collection of baseline blood sample a single dose of approximately 20mg of iron as ferrous gluconate incorporated into alginate beads (approximately 22.2g)and added to cola jelly (200ml) will be given to the volunteer together with 3 placebo capsules (each containing 50mg of dextrose)and cola drink (200ml). Once consumed, further blood samples will be taken at specified time points during 6 hour cannulation time. A minimum of 7 days wash out period will take place prior next intervention.

Also known as: iron in alginate beads

Iron in beads

ferrous gluconate in a capsule DIETARY_SUPPLEMENT

After insertion of the cannula and collection of baseline blood sample a single dose of approximately 20mg of iron as ferrous gluconate in a capsule and 2 placebo capsules (each containing 50mg of dextrose) followed by a cola jelly (200ml)and cola drink (200ml) will be given to the volunteer. Once consumed, further blood samples will be taken at specified time points during 6 hour cannulation time. A minimum of 7 days wash out period will take place prior next intervention.

Also known as: iron in capsule

Iron in capsule

ferrous gluconate in a capsule in presence of calcium DIETARY_SUPPLEMENT

After insertion of the cannula and collection of baseline blood sample a single dose of approximately 20mg of iron as ferrous gluconate in a capsule together with 2 calcium capsules (each containing 300mg of calcium phosphate)followed by cola jelly (200ml) and cola drink(200ml)will be given to the volunteer . Once consumed, further blood samples will be taken at specified time points during 6 hour cannulation time. A minimum of 7 days wash out period will take place prior next intervention.

Also known as: iron in a capsule followed by calcium phosphate

Iron in capsule in presence of calcium

alginate beads with ferrous gluconate in presence of calcium DIETARY_SUPPLEMENT

After insertion of the cannula and collection of baseline blood sample a single dose of approximately 20mg of iron as ferrous gluconate incorporated into alginate beads (approximately 22.2g)and added to cola jelly (200ml) will be given to the volunteer together with 2 calcium capsules (each containing 300mg of calcium as calcium phosphate, 1 placebo capsule (containing 50mg of dextrose)and cola drink (200ml). Once consumed, further blood samples will be taken at specified time points during 6 hour cannulation time. A minimum of 7 days wash out period will take place prior next intervention.

Also known as: iron in alginate beads in presence of calcium phosphate

Iron in beads in presence of calcium

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Apparently healthy women (aged 18-45) or male blood donors (aged 18-65)
• Serum ferritin value of ≥15 ≤ 60µg/L
• BMI \>18.5 or \< 30
• Willingness to consume jelly prepared with the use of gelatine from an animal source.

You may not qualify if:

• Diagnosed with a long-term illness requiring active treatment, e.g. diabetes, cancer, cardiovascular disease
• Currently smoking or stopped smoking in the last 12 months
• Previous or current GI disease
• Any significant co-morbidity
• Previous GI surgery
• Blood donation within the previous 3 months assuming that volume taken is above 500ml in a 4-month period
• Blood transfusion within the last 3 months
• The results of the screening tests indicate unsuitability to take part in the study
• Related to someone in the study team i.e. spouse, partner or immediate family member
• Regular prescribed medication that may interfere with iron metabolism
• Regular use of antacids and laxatives (at least once a week)
• Women who are pregnant or less than 12 months since giving birth
• Women who are breast feeding
• Vitamin supplements with or without minerals if taken more than once a week, and unwillingness to discontinue occasional use for the duration of study
• Unwillingness to discontinue use of herbal supplements for the duration of study

Sponsors & Collaborators

• University of East Anglia: lead
• Quadram Institute Bioscience: collaborator

Study Sites (1)

Clinical Research and Trials Unit (CRTU)/ Norfolk and Norwich University Hospital (NNUH)

Norwich, Norfolk, NR4 7TJ, United Kingdom

Location

Related Publications (1)

• Wawer AA, Harvey LJ, Dainty JR, Perez-Moral N, Sharp P, Fairweather-Tait SJ. Alginate inhibits iron absorption from ferrous gluconate in a randomized controlled trial and reduces iron uptake into Caco-2 cells. PLoS One. 2014 Nov 12;9(11):e112144. doi: 10.1371/journal.pone.0112144. eCollection 2014.

  PMID: 25391138 DERIVED

MeSH Terms

Conditions

Iron Deficiencies; Anemia

Interventions

Iron; ferrous gluconate; Capsules

Condition Hierarchy (Ancestors)

Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Susan Fairweather-Tait, Professor

  University of East Anglia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2012
• First Posted: February 8, 2012
• Study Start: February 1, 2012
• Primary Completion: November 1, 2012
• Study Completion: January 1, 2013
• Last Updated: March 1, 2013

Record last verified: 2013-02

Locations

GB (1)