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

Cognitive Function Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04477018
• Other study ID #: 9BN2
• Status: Completed
• Phase: N/A
• Start date: November 11, 2017
• Est. completion date: June 8, 2019

Study information

• Verified date: July 2020
• Source: Northumbria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: June 8, 2019
• Est. primary completion date: June 8, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Blood Flow
• Cognitive Function
• Energy Metabolism
• Iron

Intervention

Dietary Supplement:
• Iron bis-glycinate chelate and vitamin C
28 mg iron; 240 mg vitamin C
• Iron bis-glycinate chelate
28 mg iron only
• Placebo
Matched placebo

Locations

Country	Name	City	State
United Kingdom	Brain, Performance & Nutrition Research Centre, Northumbria University	Newcastle Upon Tyne

Sponsors (2)

Lead Sponsor	Collaborator
Northumbria University	Bayer

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cerebral Blood Flow	Near Infrared Spectroscopy outcomes for cerebral blood flow measurement at rest and during cognitive demand	16 weeks
Secondary	Serial Subtraction Performance	Performance on serial subtractions (3s and 7s) will be assessed as total responses and total errors	16 weeks
Secondary	Rapid Visual Information Processing	Performance is assessed as accuracy (%), correct reaction time (msec) and false alarms	16 weeks
Secondary	Subjective alertness	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
Secondary	Subjective fatigue	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
Secondary	Fat Oxidation	Fat oxidation will be assessed through indirect calorimetry at rest and during cognitive demand	16 weeks
Secondary	Carbohydrate Oxidation	Carbohydrate oxidation will be assessed through indirect calorimetry at rest and during cognitive demand	16 weeks
Secondary	Respiratory Energy Ratio	Respiratory energy ration will be assessed through indirect calorimetry at rest and during cognitive demand	16 weeks
Secondary	Total Energy Expenditure	Total energy expenditure will be assessed through indirect calorimetry at rest and during cognitive demand	16 weeks