Ignite Creation Date:
2024-05-06 @ 2:45 PM
Last Modification Date:
2024-10-26 @ 1:37 PM
Study NCT ID:
NCT04418102
Status:
COMPLETED
Last Update Posted:
2023-04-19
First Post:
2020-02-19
Brief Title:
The InterSat Study
Sponsor:
Kings College London
Organization:
Kings College London
Study Overview
Official Title:
The InterSat Study Interesterified Fats Health Effects of Commercially Relevant Palmitic Versus Stearic Acid Rich Interesterified Fats
Status:
COMPLETED
Status Verified Date:
2023-04
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:
InterSat
Brief Summary:
In response to the removal of trans fats from our foods the food industry now uses interesterified IE fats Randomly interesterified IE fats rich in palmitic Europe and stearic North America acids are the most commonly used IE fats by the food industry Despite their widespread use there has been no published research on the acute and chronic cardio-metabolic health effects of the most commonly consumed palmitic and stearic acid rich IE fats The aim of InterSat is to investigate the postprandial and chronic effects of a diet rich in IE fats on cardiometabolic health
Detailed Description:
Choice of design A randomised crossover study with two arms each arm consisting of a 6-week dietary intervention separated by a 3-week minimum washout period
Study population Healthy adult snackers aged 35-65 years 48 participants in total 24 at each centre see Locations
Locations
Metabolic Research Unit Franklin-Wilkins Building Waterloo Campus King College London
Metabolic Research Unit Maastricht Academic Hospital Maastricht Maastricht University
Screening Assessment Prospective participants will be selected based on the defined inclusion and exclusion criteria by the study management team Recruitment will be done over the phone and via the Internet and emails and prospective participants will be booked in for their initial appointment to acquire baseline measurements
Study duration A 2-week run-in period two 6-week dietary interventions and a 3-week minimum washout period
Dietary intervention The InterSat intervention aims to provide 10 of total daily energy intake in the form of IE fat These will be consumed in the form of muffins and spreads designed to replace typically consumed snacks and spreads throughout the day Energy requirements will be calculated using the Henry equation and physical activity levels PAL
At the baseline visit participants will have and anthropometric measures and fasted blood samples taken and will be assessed for endothelial function via flow mediated dilation FMD after which they will be provided with enough muffins and spread for a 2-week period as well a study booklet containing instructions and a diary to log muffin and spread consumption They will receive guidance on how to incorporate the muffins and spread into their diet Food collection dates will be set and participants are then free to leave At the second visit first snack collection visit no physical measures are taken but the empty tubs and muffin cases are collected and the study booklet is checked by a researcher to ensure the participant is compliant to the intervention Any issues should be discussed and guidance given to increase compliance if necessary Another snack collection visit is booked At the end of the 6-week intervention participants will undergo physical and blood sampling as well as FMD as with the baseline testing day After a 3-week minimum washout period the same procedures occur for the other arm of the trial
Anthropometry Weight height waist and hip circumference blood pressure body fat will be taken using standard procedures in duplicates by a trained researcher at all face to face appointments
Habitual food intake Participants will complete the EPIC European prospective investigation of cancer food frequency questionnaire at the screening visit They will also complete three 4-day diet diaries one at the run-in period and one in each of the dietary intervention periods
Blood samples Fasting blood samples will be collected from a superficial antecubital vein via venepuncture before and after each dietary intervention Postprandial blood samples will be taken via cannulation in a subgroup see Subgroup below for an 8-hour postprandial test day
Participants will be asked to record and monitor the following information
Amount of muffins and spread consumed study booklet Habitual intake 4-day diet diaries
Subgroup A subset n 24 of participants will undergo a postprandial test day at the baseline and 6-week points of each intervention arm After baseline samples anthropometrics blood samples FMD are taken participants will consume a breakfast containing a large bolus of the IE fat they are assigned to Blood samples will be taken over an 8-hour testing period and FMD will be taken 2 more times Liver fat will be assessed via MRI imaging Maastricht only
Study population Healthy adult snackers aged 35-65 years 48 participants in total 24 at each centre see Locations
Locations
Metabolic Research Unit Franklin-Wilkins Building Waterloo Campus King College London
Metabolic Research Unit Maastricht Academic Hospital Maastricht Maastricht University
Screening Assessment Prospective participants will be selected based on the defined inclusion and exclusion criteria by the study management team Recruitment will be done over the phone and via the Internet and emails and prospective participants will be booked in for their initial appointment to acquire baseline measurements
Study duration A 2-week run-in period two 6-week dietary interventions and a 3-week minimum washout period
Dietary intervention The InterSat intervention aims to provide 10 of total daily energy intake in the form of IE fat These will be consumed in the form of muffins and spreads designed to replace typically consumed snacks and spreads throughout the day Energy requirements will be calculated using the Henry equation and physical activity levels PAL
At the baseline visit participants will have and anthropometric measures and fasted blood samples taken and will be assessed for endothelial function via flow mediated dilation FMD after which they will be provided with enough muffins and spread for a 2-week period as well a study booklet containing instructions and a diary to log muffin and spread consumption They will receive guidance on how to incorporate the muffins and spread into their diet Food collection dates will be set and participants are then free to leave At the second visit first snack collection visit no physical measures are taken but the empty tubs and muffin cases are collected and the study booklet is checked by a researcher to ensure the participant is compliant to the intervention Any issues should be discussed and guidance given to increase compliance if necessary Another snack collection visit is booked At the end of the 6-week intervention participants will undergo physical and blood sampling as well as FMD as with the baseline testing day After a 3-week minimum washout period the same procedures occur for the other arm of the trial
Anthropometry Weight height waist and hip circumference blood pressure body fat will be taken using standard procedures in duplicates by a trained researcher at all face to face appointments
Habitual food intake Participants will complete the EPIC European prospective investigation of cancer food frequency questionnaire at the screening visit They will also complete three 4-day diet diaries one at the run-in period and one in each of the dietary intervention periods
Blood samples Fasting blood samples will be collected from a superficial antecubital vein via venepuncture before and after each dietary intervention Postprandial blood samples will be taken via cannulation in a subgroup see Subgroup below for an 8-hour postprandial test day
Participants will be asked to record and monitor the following information
Amount of muffins and spread consumed study booklet Habitual intake 4-day diet diaries
Subgroup A subset n 24 of participants will undergo a postprandial test day at the baseline and 6-week points of each intervention arm After baseline samples anthropometrics blood samples FMD are taken participants will consume a breakfast containing a large bolus of the IE fat they are assigned to Blood samples will be taken over an 8-hour testing period and FMD will be taken 2 more times Liver fat will be assessed via MRI imaging Maastricht only
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