Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06418763
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-25
First Post:
2024-04-23
Brief Title:
The Effects of Fermented Brown Seaweed Intake on Glucose Metabolism and Gut Health
Sponsor:
Aventure AB
Organization:
Aventure AB
Study Overview
Official Title:
The Effects of Fermented Brown Seaweed Intake on Glucose Metabolism and Gut Health a Short-term Study in Healthy Subjects
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
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:
SEAPRO01
Brief Summary:
The aim of this randomised controlled cross-over study is to investigate whether the intake of fermented brown seaweed can lower postprandial blood glucose levels and influence the composition of the gut microbiota in 25 healthy volunteers Well-being and gastrointestinal symptoms as well as sensory properties of the products will also be evaluated using questionnaires
At the screening visit the subjects will be informed about the study procedures and inclusionexclusion criteria will be checked Informed consent will be signed by each subject before participating in the study The participants will consume the active and control product respectively for 5 days with a 14-day wash-out period in between Capillary blood samples will be drawn for glucose measurement at the first day of each 5-day intervention period Faecal samples will be collected before and after each 5-day intervention period to analyse changes in gut microbial composition
At the screening visit the subjects will be informed about the study procedures and inclusionexclusion criteria will be checked Informed consent will be signed by each subject before participating in the study The participants will consume the active and control product respectively for 5 days with a 14-day wash-out period in between Capillary blood samples will be drawn for glucose measurement at the first day of each 5-day intervention period Faecal samples will be collected before and after each 5-day intervention period to analyse changes in gut microbial composition
Detailed Description:
Fermented seaweed is a sustainable food with increasing interest as an ingredient of a plant-based diet Plant-based diets are gaining popularity both because of their health benefits and low-carbon footprint Seaweed is a rich source of minerals polyphenols and dietary fibres like xylans carrageenan fucoidan laminarin and alginate These bioactive compounds have been shown to exert positive effects on metabolic parameters such as blood glucose and insulin blood lipid profile and inflammatory markers and could therefore help in the prevention of cardiovascular diseases Besides possible health benefits fermentation of seaweed can offer potential advantages such as improved food safety and shelf life of non-dried seaweed as well as improved sensory properties
The project aims to investigate the effects of fermented brown seaweed Alaria Esculenta also known as winged kelp on glucose metabolism and its prebiotic potential in humans A short-term pilot study 5-day intake period will be conducted in young healthy subjects
Twenty-five healthy subjects will be recruited to this study This study will be a randomised controlled cross-over study where all participants will consume the test product and the control product for 5 days In between each 5-day intervention period there will be a wash-out period of 2 weeks
At the first day of each 5-day intake period the subjects have to come to the study centre in the morning in a fasting state A test meal with the active product or control product containing each 50g of total carbohydrates will be served Blood samples finger-pricking will be taken at fasting state 0 min and at 15 30 45 60 90 120 150 and 180 min The participants will then consume the product daily for 5 days at a dose of 2x 15g baobab with or without control 15 of the fermented seaweed The product will be available as a spread in packages of 15g After a wash-out period of 2 weeks the participants will take the other product cross-over design
Faecal samples will be collected before and at the end of each 5-day intervention period The questionnaire about well-being and gastrointestinal symptoms will be filled at home daily during each 5-day intervention Also a sensory questionnaire will be filled in at day 1 and 5 of intervention period
The project aims to investigate the effects of fermented brown seaweed Alaria Esculenta also known as winged kelp on glucose metabolism and its prebiotic potential in humans A short-term pilot study 5-day intake period will be conducted in young healthy subjects
Twenty-five healthy subjects will be recruited to this study This study will be a randomised controlled cross-over study where all participants will consume the test product and the control product for 5 days In between each 5-day intervention period there will be a wash-out period of 2 weeks
At the first day of each 5-day intake period the subjects have to come to the study centre in the morning in a fasting state A test meal with the active product or control product containing each 50g of total carbohydrates will be served Blood samples finger-pricking will be taken at fasting state 0 min and at 15 30 45 60 90 120 150 and 180 min The participants will then consume the product daily for 5 days at a dose of 2x 15g baobab with or without control 15 of the fermented seaweed The product will be available as a spread in packages of 15g After a wash-out period of 2 weeks the participants will take the other product cross-over design
Faecal samples will be collected before and at the end of each 5-day intervention period The questionnaire about well-being and gastrointestinal symptoms will be filled at home daily during each 5-day intervention Also a sensory questionnaire will be filled in at day 1 and 5 of intervention period
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