- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04257669
The Relationship Between Iron Status, Cognitive Performance, Subjective Mood and Fatigue in Women of Reproductive Age.
The Relationship Between Iron Status, Cognitive Performance, Subjective Mood and Fatigue in Women of Reproductive Age
Study Overview
Status
Conditions
Detailed Description
Each participant will be required to attend the laboratory on two 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.
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Newcastle Upon Tyne, United Kingdom, NE1 8ST
- Brain, Performance & Nutrition Research Centre, Northumbria University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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 over 49
- BMI lower than 18.5 or higher than 40
- Pre-existing medical condition/illness with some exceptions - please check with researcher
- Blood disorders (excluding 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
- 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
- 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 fulfillment of the study requirements
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Iron sufficient
Haemoglobin ≥120g/L Serum ferritin > 20μg/L
|
Non-anaemic iron deficient
Haemoglobin ≥120g/L Serum ferritin ≤ 20μg/L
|
Iron deficient anaemic
Haemoglobin <120g/L Serum ferritin ≤ 20μg/L
|
Anaemic without iron deficiency
Haemoglobin <120g/L Serum ferritin > 20μg/L
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Speed of attention
Time Frame: Baseline measure
|
An overall score for Speed of attention will be derived by calculating the average score from 3 separate standardised task outcomes (ZChoice reaction time correct reaction time + ZRapid visual information processing correct reaction time + ZDigit vigilance correct reaction time) /3
|
Baseline measure
|
Subjective fatigue
Time Frame: Baseline measure
|
Subjective fatigue will be derived from the total score of the Piper Fatigue Scale.
Scores range from 1 to 10. Higher scores are indicative of greater fatigue.
|
Baseline measure
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Episodic memory
Time Frame: Baseline measure
|
An overall score for episodic memory will be derived by calculating the average score from 4 separate standardised task outcomes (Zimmediate word recall accuracy + Zdelayed word recall accuracy + Zword recognition accuracy + Zpicture recognition accuracy)/4
|
Baseline measure
|
Speed of memory
Time Frame: Baseline measure
|
An overall score for speed of memory will be derived by calculating the average score from 2 separate standardised task outcomes (Zpicture recognition correct reaction time + Zword recognition correct reaction time)/2
|
Baseline measure
|
Accuracy of attention
Time Frame: Baseline measure
|
An overall score for accuracy of attention will be derived by calculating the average score from 3 separate standardised task outcomes (ZChoice reaction time accuracy + ZZRapid visual information processing accuracy + ZZDigit Vigilance accuracy)/3
|
Baseline measure
|
Executive function
Time Frame: Baseline measure
|
An overall score for executive function will be derived by calculating the average score from 5 separate standardised task outcomes (Znumeric working memory accuracy + ZZserial 3 subtractions accuracy + ZZserial 7 subtractions accuracy + ZStroop accuracy - ZPeg and Ball errors)/5
|
Baseline measure
|
Speed of executive function
Time Frame: Baseline measure
|
An overall score for speed of executive function will be derived by calculating the average score from 3 separate standardised task outcomes (Znumeric working memory correct reaction time + Zstroop correct reaction time + ZPeg and Ball overall reaction time)/3
|
Baseline measure
|
Computerised Location learning Task
Time Frame: Baseline measure
|
An overall score is calculated utilising the total displacement over the 5 learning trials to create a total learning index score.
Scores range from 0 to 1.
|
Baseline measure
|
Subjective overall mood disturbance
Time Frame: Baseline measure
|
Subjective mood disturbance is derived from the overall score of the Profile of Mood States questionnaire.
Higher scores indicate a greater degree of overall mood disturbance.
|
Baseline measure
|
Subjective sleep quality
Time Frame: Baseline measure
|
Subjective sleep quality is derived from the overall score of the Sleep Condition Indicator.
Total scores ranged from 0 to 32.
Higher scores are indicative of greater subjective sleep quality.
|
Baseline measure
|
Subjective stress
Time Frame: Baseline measure
|
Subjective stress is derived from the overall score of the Perceived Stress Scale.
Higher scores are indicative of greater subjective stress
|
Baseline measure
|
Health Outcomes
Time Frame: Baseline measure
|
Subjective health outcomes are derived from the SF-12.
Scores range from 0 to 100.
Higher scores are indicative of better self-reported health.
|
Baseline measure
|
Subjective alertness
Time Frame: Baseline measure
|
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.
|
Baseline measure
|
Subjective mental fatigue
Time Frame: Baseline measure
|
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.
|
Baseline measure
|
Global Accuracy
Time Frame: Baseline measure
|
An overall score for global accuracy will be derived by calculating the average score from 13 separate standardised outcomes (ZChoice reaction time accuracy + ZZRapid visual information processing accuracy + ZNumeric working memory accuracy + ZZDigit Vigilance accuracy + ZStroop accuracy - ZPeg and Ball Errors + ZZSerial 3 subtractions accuracy + ZZSSerial 7 subtractions accuracy + ZPicture recognition accuracy + ZWord recognition accuracy + ZImmediate word recall accuracy + ZDelayed word recall accuracy + ZZComputerised location learning accuracy)/13
|
Baseline measure
|
Global Speed
Time Frame: Baseline measure
|
An overall score for global speed will be derived by calculating the average score from 8 separate standardised outcomes (ZChoice reaction time correct reaction time + ZNumeric working memory correct reaction time + ZDigit vigilance correct reaction time + ZZPeg and Ball overall reaction time + ZStroop correct reaction time + ZPicture recognition correct reaction time + ZWord recognition correct reaction time + ZRapid visual information correct reaction time) /8
|
Baseline measure
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- Murray-Kolb LE, Beard JL. Iron treatment normalizes cognitive functioning in young women. Am J Clin Nutr. 2007 Mar;85(3):778-87. doi: 10.1093/ajcn/85.3.778.
- Scott SP, Murray-Kolb LE. Iron Status Is Associated with Performance on Executive Functioning Tasks in Nonanemic Young Women. J Nutr. 2016 Jan;146(1):30-7. doi: 10.3945/jn.115.223586. Epub 2015 Dec 9.
- Blanton CA, Green MW, Kretsch MJ. Body iron is associated with cognitive executive planning function in college women. Br J Nutr. 2013 Mar 14;109(5):906-13. doi: 10.1017/S0007114512002620. Epub 2012 Jun 7.
- Fordy J, Benton D. Does low iron status influence psychological functioning? Journal of Human Nutrition and Dietetics 115: 167-183, 1994.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 9BM1
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Iron Status
-
Research Institute of Child Nutrition, DortmundCompletedIron Status | Fatty Acid StatusGermany
-
North-West University, South AfricaMedical Research Council, South Africa; National Research Foundation of South... and other collaboratorsCompletedMalnutrition | Vitamin A Status | Iron Status | Zinc StatusSouth Africa
-
Mahidol UniversitySuranaree University of TechnologyRecruiting
-
Thomas WalczykUnknownEffect of Iron Status on Occurrence of NTBISingapore
-
Assiut UniversityNot yet recruitingIron Study of Neonates: Factors Affecting and Impact on Their Health Status at Birth in Assuit University Children's Hospital
-
Stanger HospitalOtto Kranendonk Fonds - Dutch Association of Tropical Health (request pending)CompletedLow Birth Weight | Perinatology | Iron Status | Cord ClampingSouth Africa
-
University of ReadingUnilever R&DNot yet recruitingFocus of Study: 1- Effect of Tea Consumption on Gut Microbiota | Focus of Study: 2- Effect of Tea Consumption on Body-iron StatusUnited Kingdom
-
Umeå UniversityUniversity of California; Mead Johnson NutritionActive, not recruitingHealth of Formula-fed Children | Infant Infections in Formula-fed Children | Iron Status of Formula-fed ChildrenSweden
-
Nutrition Institute, SloveniaNational Institute of Public Health, Slovenia; University Medical Centre Ljubljana and other collaboratorsEnrolling by invitationObesity | Iron-deficiency | Vitamin D Deficiency | Nutritional Status | Sarcopenia | Vitamin B 12 Deficiency | Folic Acid Deficiency | Diet | Nutrient Deficiency | Micronutrient Deficiency | Protein DeficiencySlovenia
-
Swiss Federal Institute of TechnologyJomo Kenyatta University of Agriculture and TechnologyCompletedIron-deficiency | Iron Absorption | Ferritin Threshold | Stable Iron IsotopesKenya