16 Weeks' Dietary Supplementation With Iron and Iron + Vitamin C on Cerebral Blood Flow and Energy Expenditure in Women of Reproductive Age

NCT04477018 | Completed

• 1 other identifier: 9BN2
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

Iron deficiency is the most prevalent nutritional deficiency worldwide with one in four estimated to be affected by iron deficiency anaemia. Women of reproductive age are at greatest risk for iron deficiency and anaemia due to iron losses during menstruation and childbirth as well as the increased need for iron throughout pregnancy. However, iron deficiency without anaemia is at least twice as common as iron deficiency anaemia with females aged 11-49 at the biggest risk of all. Despite this, it is commonly left undiagnosed. Those who are iron deficient non-anaemic can still suffer from the same common consequences of iron deficiency anaemia; these include unexplained fatigue, mood changes and decreased cognitive performance. It is postulated that for any cognitive and behavioural change to occur, a complementary change in neural functioning is required. A recent cross-sectional study has identified increases in cognitive demand to produce decrements in measures of cognitive performance and increases in brain activity and metabolic measures; the magnitude of such are evidenced to be directly related to iron status. However, such measures do not provide an estimate of overall oxygen consumption that is specific to the brain in order to be able to associate changes in cognitive performance and energy expenditure specifically to the brain itself. The current study aims to investigate the parallel effects of iron supplementation on cerebral haemodynamics and energy metabolism to determine the ability of iron to modulate whole body energy metabolism and utilisation of metabolic substrates at rest and during cognitive demand in a sample of non-anaemic iron deficient and iron sufficient women of reproductive age.

Conditions

Iron; Cerebral Blood Flow; Energy Metabolism; Cognitive Function

Keywords

Iron supplementation; Cerebral blood flow; Near infrared spectroscopy; Indirect calorimetry; Energy metabolism

Outcome Measures

Primary Outcomes (1)

• Cerebral Blood Flow

  Near Infrared Spectroscopy outcomes for cerebral blood flow measurement at rest and during cognitive demand

  16 weeks

Secondary Outcomes (8)

• Serial Subtraction Performance

  16 weeks

• Rapid Visual Information Processing

  16 weeks

• Subjective alertness

  16 weeks

• Subjective fatigue

  16 weeks

• Fat Oxidation

  16 weeks

Study Arms (3)

Iron and Vitamin C

EXPERIMENTAL

28 mg iron bis-glycinate chelate and 240 mg vitamin C

Dietary Supplement: Iron bis-glycinate chelate and vitamin C

Iron

ACTIVE COMPARATOR

28 mg iron bis-glycinate chelate

Dietary Supplement: Iron bis-glycinate chelate

Placebo

PLACEBO COMPARATOR

Matched placebo tablets

Dietary Supplement: Placebo

Interventions

Iron bis-glycinate chelate and vitamin C DIETARY_SUPPLEMENT

28 mg iron; 240 mg vitamin C

Iron and Vitamin C

Iron bis-glycinate chelate DIETARY_SUPPLEMENT

28 mg iron only

Iron

Placebo DIETARY_SUPPLEMENT

Matched placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 49 Years
• Gender Eligibility Details: Must be female at birth
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy
• Female
• Aged 18-49 (inclusive)
• Have a BMI of between 18.5-40
• Have an English bank account (required for payment)

You may not qualify if:

• Aged under 18 or above 49 years
• BMI lower than 18.5 or higher than 40
• Pre-existing medical condition/illness with some exceptions - please check with researcher
• Blood disorders (including anaemia) or any known active infections
• Current or past breast cancer diagnosis and/or mastectomy
• Smoking or use of any nicotine replacement products e.g. vaping, gum, patches
• Pregnant, trying to get pregnant or breast feeding
• Currently taking any prescription medication with some exceptions - please check with researcher
• Food allergies/sensitivities relevant to the study
• Regular use of dietary/herbal supplements within the last month (defined as more than 3 consecutive days or 4 days in total)
• Use of iron supplements within the past 4 months
• Have donated more than 300ml of blood in the past 3 months
• Have haemoglobin levels below 120g/L
• History of significant head trauma or suffer from frequent migraines that require medication (more than or equal to one per month)
• Learning difficulties, dyslexia, or colour blindness

Sponsors & Collaborators

• Northumbria University: lead
• Bayer: collaborator

Study Sites (1)

Brain, Performance & Nutrition Research Centre, Northumbria University

Newcastle upon Tyne, NE1 8ST, United Kingdom

Location

MeSH Terms

Interventions

Ascorbic Acid

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will receive either iron and vitamin C, iron alone or placebo for a period of 16 weeks to consume daily

Study Record Dates

• First Submitted: July 9, 2020
• First Posted: July 20, 2020
• Study Start: November 11, 2017
• Primary Completion: June 8, 2019
• Study Completion: June 8, 2019
• Last Updated: July 20, 2020

Record last verified: 2020-07

Locations

GB (1)