Status:
COMPLETED
Efficacy Evaluation of 16 Weeks' Dietary Supplementation With Iron Bis-glycinate Plus Vitamin C on Cognitive Function, Subjective Mood, Fatigue, Health and Well-being
Lead Sponsor:
Northumbria University
Collaborating Sponsors:
Bayer
Conditions:
Cognitive Function and Mood
Non-anaemic Iron Deficiency
Eligibility:
FEMALE
18-49 years
Phase:
NA
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 def...
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. ...
Eligibility Criteria
Inclusion
- Healthy
- Female
- Aged 18-49 (inclusive)
- Have a BMI of between 18.5-40
- Have an English bank account (required for payment)
Exclusion
- 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 fulfillment of the study requirements
Key Trial Info
Start Date :
June 2 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 19 2019
Estimated Enrollment :
151 Patients enrolled
Trial Details
Trial ID
NCT04469010
Start Date
June 2 2017
End Date
July 19 2019
Last Update
July 13 2020
Active Locations (1)
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1
Northumbria University
Newcastle upon Tyne, Tyne and Wear, United Kingdom, NE1 8ST