Ignite Creation Date:
2024-05-06 @ 4:05 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04867031
Status:
COMPLETED
Last Update Posted:
2023-01-10
First Post:
2021-04-27
Brief Title:
Impact of the Food Matrix on Iodine Bioavailability
Sponsor:
University of Glasgow
Organization:
University of Glasgow
Study Overview
Official Title:
Impact of the Food Matrix on Iodine Bioavailability
Status:
COMPLETED
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is a randomized crossover trial lasting 12 days in total which will assess the difference in iodine bioavailability as a percentage of iodine consumed that is excreted in urine from three iodine-rich foods semi-skimmed milk white fish and dried seaweed sheets Each of the three foods will provide approximately 140µg of iodine and iodine excretion will be monitored for 36 hours following food ingestion via collection and analysis of urine
Detailed Description:
Iodine insufficiency is one of the three key micronutrient deficiencies highlighted as major public health issues by the World Health Organisation and recent evidence indicates that the UK is now iodine deficient Iodine deficiency represents a particular threat for women of child-bearing age unborn infants and young children as iodine is essential to synthesise the thyroid hormones which are involved in key metabolic function including fetal brain development Maternal iodine deficiency and the resulting changes in thyroid function has been associated with adverse pregnancy outcomes including spontaneous miscarriage fetal distress and death preterm delivery low birth weight and impaired neuropsychological development with significant impact on later life development and quality of life
There is no iodine fortification programme in the United Kingdom and despite worldwide efforts to tackle iodine deficiency and associated disorders via iodine supplementation and food-fortification of salt mainly consumption of supplements in the UK is virtually non-existent with iodised salt used by less than 5
In the UK the main dietary sources of iodine are dairy and sea-foods Our previous studies have shown that seaweed intake can increase the iodine status of women with diets habitually low in iodine Reduced bioavailability of iodine from the seaweed matrix which could have implications for dietary recommendations
This study address the influence of the food matrix on iodine bioavailability in the context of food guidelines and assessment of the iodine status
This project is in collaboration with the British Broadcast Corporation BBC
The study design is a crossover randomised trial - to last 9 days plus three days pre-trial washout total 12 days - with 3 arms
1 fish arm portion equivalent to 140 µg iodine approx 130g
2 milk arm portion equivalent to 140 µg iodine approx 450mL
3 seaweed arm portion equivalent to 140 µg iodine approx 6g
Each arm will be separated by two washout days and participants will follow a low iodine diet avoiding dairy and all seafood throughout the study as well as three days prior to the first arm Iodine levels will be monitored in urine collected during the 12 hours preceding and 36 hours following the meal Urine will be collected in time fractions
A parallel design study showed that 56 SD 20 of a dose of potassium iodide is excreted after 24hours compared to 36 SD 13 when the same dose comes from seaweed In order to detect a similar difference a sample of at least 13 participants is required n19 to allow for 30 attrition
There is no iodine fortification programme in the United Kingdom and despite worldwide efforts to tackle iodine deficiency and associated disorders via iodine supplementation and food-fortification of salt mainly consumption of supplements in the UK is virtually non-existent with iodised salt used by less than 5
In the UK the main dietary sources of iodine are dairy and sea-foods Our previous studies have shown that seaweed intake can increase the iodine status of women with diets habitually low in iodine Reduced bioavailability of iodine from the seaweed matrix which could have implications for dietary recommendations
This study address the influence of the food matrix on iodine bioavailability in the context of food guidelines and assessment of the iodine status
This project is in collaboration with the British Broadcast Corporation BBC
The study design is a crossover randomised trial - to last 9 days plus three days pre-trial washout total 12 days - with 3 arms
1 fish arm portion equivalent to 140 µg iodine approx 130g
2 milk arm portion equivalent to 140 µg iodine approx 450mL
3 seaweed arm portion equivalent to 140 µg iodine approx 6g
Each arm will be separated by two washout days and participants will follow a low iodine diet avoiding dairy and all seafood throughout the study as well as three days prior to the first arm Iodine levels will be monitored in urine collected during the 12 hours preceding and 36 hours following the meal Urine will be collected in time fractions
A parallel design study showed that 56 SD 20 of a dose of potassium iodide is excreted after 24hours compared to 36 SD 13 when the same dose comes from seaweed In order to detect a similar difference a sample of at least 13 participants is required n19 to allow for 30 attrition
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None