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

July 15, 2020 updated by: Northumbria University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Each participant will be required to attend the laboratory on four occasions. The first is comprised of a screening/training visit, which will take place in the afternoon for approximately 2.5 hours. This will also be between days 21-28/ the week before onset of their menstrual cycle. If they do not have menstrual bleeds then this appointment can be any afternoon. This will comprise: briefing of requirements of the study; obtaining of informed consent; confirmation of eligibility to take part, including collection of demographic data and health screening, and training on the cognitive and mood measures. The training session will follow standard operating procedures to decrease the chance of learning effects during main trials. Extra training will be given where necessary.

Participants will be required to complete questionnaires based upon food frequency, caffeine consumption and to estimate the number of hours of exercise completed on a weekly basis. A menstrual cycle questionnaire will also be completed to estimate menstrual blood loss and so that participants attend their testing visit during days 7-14 of their cycle. If participants do not have a menstrual cycle due to contraceptive methods, then appointments will be approximately two weeks apart. A finger-prick and venous blood sample will be collected from participants, which will be analysed for iron status. Those whose haemoglobin levels are <120g/L will be advised to seek advice from their GP. Participants who fell into the iron status category of iron sufficient (haemoglobin ≥120 g/L and serum ferritin > 20 µg/L) or non-anaemic iron deficient (haemoglobin ≥120 g/L and serum ferritin ≤ 20 µg/L) will be informed of their eligibility for the intervention study by email or phone between the initial visit and their next. This will include the option to enrol in an additional assessment of neuroimaging and energy metabolism.

For the testing visit, participants will be asked to fast for 12 hours prior to the visit, avoiding intake of all food and drink with the exception of water. They will also be asked to avoid alcohol and refrain from intake of 'over the counter' medication for 24 hours. Participants will arrive at the laboratory at a designated time in the morning. The following procedures will take place prior to cognitive and mood testing:

Review of continued conformity to eligibility criteria Adverse event and concomitant medication assessment Ensure that participant is in good health

Participants will then complete the baseline cognitive and mood assessments. Following this, participants are informed of their iron status and will be briefed regarding the requirements of the intervention study and additional assessment. Following this, informed consent will be obtained prior to starting the additional assessment. Participants will have a frequency domain near-infrared spectroscopy headband attached to the forehead to measure cerebral blood flow at rest for five minutes. Following this, participants will instead have a continuous wave near-infrared spectroscopy headband attached to the forehead to measure cerebral blood flow, and a face mask fitted to measure expired air. Participants will have another five minute rest before completing an additional battery of cognitive tasks for approximately 35-40 minutes. Once complete, participants will be randomised to one of three treatments and be provided with a treatment diary to log treatment consumption and any adverse events experienced.

Participants will return to the laboratory after 8 weeks to exchange treatment bottles and diaries in order to check compliance.

Participants will finally return to the laboratory after a further 8 weeks (16 weeks total). The same procedures will take place prior to cognitive and mood testing as completed at the baseline testing visit, with the addition of finger prick and venous blood sample and weight measurement. Participants will then complete the same cognitive, mood and neuroimaging and energy metabolism assessments as completed during the baseline testing visit.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
78

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Newcastle Upon Tyne, United Kingdom, NE1 8ST
        • Brain, Performance & Nutrition Research Centre, Northumbria University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 49 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  • Visual impairment that cannot be corrected with glasses or contact lenses
  • Currently taking part in any other clinical or nutritional intervention studies or have in the past 4 weeks
  • Any health condition that would prevent fulfilment of the study requirements

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Matched placebo tablets
Dietary supplement: Placebo
Matched placebo
Experimental: Iron and Vitamin C
28 mg iron bis-glycinate chelate and 240 mg vitamin C
Dietary supplement: Iron bis-glycinate chelate and vitamin C
28 mg iron; 240 mg vitamin C
Active Comparator: Iron
28 mg iron bis-glycinate chelate
Dietary supplement: Iron bis-glycinate chelate
28 mg iron only

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Cerebral Blood Flow
Time Frame: 16 weeks
Near Infrared Spectroscopy outcomes for cerebral blood flow measurement at rest and during cognitive demand
16 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Serial Subtraction Performance
Time Frame: 16 weeks
Performance on serial subtractions (3s and 7s) will be assessed as total responses and total errors
16 weeks
Rapid Visual Information Processing
Time Frame: 16 weeks
Performance is assessed as accuracy (%), correct reaction time (msec) and false alarms
16 weeks
Subjective alertness
Time Frame: 16 weeks
Subjective alertness will be derived from an Alertness visual analogue scale presented following cognitive task performance. Scores range from 0 to 100. Higher scores are indicative of greater feelings of alertness.
16 weeks
Subjective fatigue
Time Frame: 16 weeks
Subjective mental fatigue will be derived from a Mental Fatigue visual analogue scale presented following cognitive task performance. Scores range from 0 to 100. Higher scores are indicative of greater feelings of mental fatigue.
16 weeks
Fat Oxidation
Time Frame: 16 weeks
Fat oxidation will be assessed through indirect calorimetry at rest and during cognitive demand
16 weeks
Carbohydrate Oxidation
Time Frame: 16 weeks
Carbohydrate oxidation will be assessed through indirect calorimetry at rest and during cognitive demand
16 weeks
Respiratory Energy Ratio
Time Frame: 16 weeks
Respiratory energy ration will be assessed through indirect calorimetry at rest and during cognitive demand
16 weeks
Total Energy Expenditure
Time Frame: 16 weeks
Total energy expenditure will be assessed through indirect calorimetry at rest and during cognitive demand
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Northumbria University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 11, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 8, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 8, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 9, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 15, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 20, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 20, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 15, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 9BN2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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