Efficacy Evaluation of 16 Weeks' Dietary Supplementation With Iron Bis-glycinate Plus Vitamin C on Cognitive Function, Subjective Mood, Fatigue, Health and Well-being in Non-anaemic Iron Deficient and Iron Sufficient Women of Reproductive Age
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 151
- 试验地点
- 1
- 主要终点
- Speed of attention
研究概览
简要总结
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. However, randomised controlled trials (RCTs) assessing the effect of iron supplementation upon cognitive performance, mood, fatigue and well-being in non-anaemic iron deficient women of reproductive age are limited. There is also a lack of well-defined diagnostic criteria for non-anaemic iron deficiency, which makes comparisons across RCTs difficult. However, there is evidence to suggest that a haemoglobin cut off of ≥120 g/L and serum ferritin ≤ 20 µg/L provides an accurate indication of non-anaemic iron deficiency in women of reproductive age; this is inclusive of the ability to recognise iron-associated deficits in psychological and physiological functioning. Additionally, previous RCTs could be improved by utilising a lower dose of iron in a bis-glycinate chelate form, which is evidenced to have superior bioavailability, tolerability and subsequent efficacy compared to ferrous formulations. Iron bis-glycinate absorption is also negatively associated to serum ferritin levels, which is suggestive of a non-anaemic iron deficient population benefitting most from it's administration. The current study aims to build upon previous iron RCTs in populations of non-anaemic iron deficient and iron sufficient women of reproductive age by investigating the effects of 16-weeks supplementation with either iron bis-glycinate chelate alone, iron bis-glycinate plus vitamin C (as ascorbic acid) or matched placebo upon cognitive performance, subjective mood, fatigue, health and well-being.
详细描述
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.
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. Following this, informed consent will be obtained prior to randomising participants to one of three treatments and providing them 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Aged 18-49 (inclusive)
- •Have a BMI of between 18.5-40
- •Have an English bank account (required for payment)
排除标准
- •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
研究组 & 干预措施
Iron and Vitamin C
28mg iron bis-glycinate chelate and 240mg vitamin C
干预措施: Iron Bis-Glycinate Chelate and Vitamin C (Dietary Supplement)
Iron
28mg iron bis-glycinate chelate
干预措施: Iron Bis-Glycinate Chelate (Dietary Supplement)
Placebo
Matched placebo tablets
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Speed of attention
时间窗: 16 weeks
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
Subjective fatigue
时间窗: 16 weeks
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.
次要结局
- Health outcomes(16 weeks)
- Global speed(16 weeks)
- Accuracy of episodic memory(16 weeks)
- Speed of episodic memory(16 weeks)
- Computerised location learning task(16 weeks)
- Subjective overall mood disturbance(16 weeks)
- Subjective sleep quality(16 weeks)
- Subjective alertness(16 weeks)
- Accuracy of attention(16 weeks)
- Accuracy of executive function(16 weeks)
- Speed of executive function(16 weeks)
- Subjective mental fatigue(16 weeks)
- Subjective stress(16 weeks)
- Global accuracy(16 weeks)