Ignite Creation Date:
2024-07-17 @ 10:46 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06484543
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-06-04
Brief Title:
Brown Fat as Therapeutic Strategy for Obesity and Associated Metabolic Diseases Via Functional FoodNutraceutical Approach - Molecular Mechanisms of Pentacyclic Triterpenes BRACE
Sponsor:
Singapore Institute for Clinical Sciences
Organization:
Singapore Institute for Clinical Sciences
Study Overview
Official Title:
Brown Fat as Therapeutic Strategy for Obesity and Associated Metabolic Diseases Via FunctionalNutraceutical Approach - Molecular Mechanisms of Pentacyclic Triterpenes BRACE
Status:
RECRUITING
Status Verified Date:
2024-10
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:
To examine MA Maslinic Acid safety and efficacy in ameliorating insulin resistance and the cardinal features of metabolic syndrome Chronic exposure to MA as a potent PPARgamma binder nutraceutical over 12 weeks will result in improvement in the features of metabolic syndrome including waist circumference blood pressure serum HDL-C level fasting serum triglycerides and fasting plasma glucose Expected secondary endpoints include favorable changes in metabolic rate respiratory quotient fat oxidation body composition weight BATWAT compartments batokinesadipokines proinflammatory biomarkers insulin sensitivity and beta cell function
Detailed Description:
Up to 50 participants that are overweightobese people suffering from metabolic syndromepre-metabolic syndrome will be recruited for this study They will be asked to come to the Clinical Nutrition Research Centre CNRC for a screening session 1st visit and given plenty of time to read this information sheet and the opportunity to ask questions Once they are fully informed regarding the study and all their questions have been satisfactorily answered they will be given a consent form to complete and sign in the presence of the researcher Following this in order to gauge their suitability for taking part in the study an assessment will be carried out This assessment needs to be carried out in a fasted state and they would therefore have to come one morning following an overnight fast The screening will include anthropometric measurements blood pressure measurement and blood sampling Anthropometric measurements taken will be height weight waist circumference and hip circumference Body composition will be measured using an electrical impedance analyser BIA Blood pressure will be measured using an automatic blood pressure monitor They will also undergo a blood sampling from their vein 6 mL or approximately 15 teaspoons to be tested for thyroid function glucose and lipid profile Once they have been accepted into the study they will then be expected to come to the centre for a total of four separate test sessions over a span of approximately 3 months two test sessions each at week 0 before intervention and at week 12 after intervention which will be scheduled within 4 weeks from each timepoint and will be randomly assigned via wwwrandomorg to either the MA or placebo groups below up to 25 subjects per group This is a single-blind study in which the participants will not know which group will be assigned to and only the investigators will know After completing the two test sessions for week 0 both groups will start consuming either the 60mg of MA or placebo once depending on which group they are assigned to daily after breakfast for 12 weeks For each of the four test sessions they will be required to fast overnight and avoid caffeine and alcohol for 8-10 hours before reporting at the CNRC in the morning between 8 to 9 AM Only plain water can be consumed during the fast They are to avoid any physical activityexercise and alcohol on the day prior to the visit The test sessions will be as follows On the first test session 2nd visit at week 0 before intervention they will need to come to CNRC in the morning in a fasted state and an intravenous indwelling cannula will be inserted into an arm vein to collect a fasting blood sample 40ml or approximately 8 teaspoons and an urine sample will also collected They will then proceed to undergo metabolic rate measurement with IRT focusing on their neck and area above the collar bone in a whole body room calorimeter WBC for the next 45 minutes They will then undergo a mild cold stimulation of about 14 degree Celcius by wearing a cooling vest for the next 15 hours in which metabolic rate measurement and IRT in the WBC will be performed during this period Wearing the cooling vest may lead to some shivering but it is generally considered safe Upon exiting the WBC they will remove the cooling vest and 20ml approximately 4 teaspoons of blood sample and another urine sample will be collected again After which they will be free to leaveOn the second test session 3rd visit at week 0 before intervention they will need to come to CNRC in the morning in a fasted state and anthropometric measurements like height weight waist circumference and hip circumference will be taken Body composition will be measured using an electrical impedance analyser BIA and blood pressure will be measured using an automatic blood pressure monitor They will then undergo a body composition evaluation using dual energy X-ray absorptiometry DXA approximately 20 mins duration which allows quantification of fat lean and bone mass After that an intravenous indwelling cannula will be inserted into an arm vein to collect a fasting timepoint 0min blood sample 5ml or approximately 1 teaspoon Subsequently they will undergo a 120-minutes oral glucose tolerance test OGTT where you will be required to consume a glucose drink 75g of glucose within 5 minutes Following the consumption of the glucose drink we will take further blood samples from the cannula every 30 minutes for the remaining 120 minutes 4 timepoints at 30 60 90 and 120 min At each time point approximately 5 ml or approximately 1 teaspoon of blood will be drawn
During the entire test session they will have to stay rested and in the laboratory Television and a workspace will be provided for their use if they require At the end of 2 hours of testing they will be free to leave The above 2 test sessions may be scheduled in any order but to be completed no more than 4 weeks apart They will now start the study intervention for the next 12 weeks Depending on which group they are assigned to they will be instructed to consume either 60mg of MA or placebo daily after breakfast for the next 12 weeks They will then be required to come for the third test session 4th visit and fourth test session 5th visit at week 12 after completing the 12 weeks of intervention and repeat the same procedures as per that of the first test session 2nd visit and the second test session 3rd visit respectively The 2 test sessions each at week 0 and 12 may be scheduled within 4 weeks from each time point During the course of the study there is a possibility that we might unintentionally come to know of new information about their health condition from eg the screening blood test etc that are conducted as part of the study These are called incidental findings Incidental findings are findings that have potential health or reproductive importance to research participants like you and are discovered in the course of conducting the study but are unrelated to the purposes objectives or variables of the study These findings may affect your current or future life andor health insurance coverage Examples of potential incidental findings that may be discovered during the course of this study may include but are not limited to greater than normal range of fasting glucose insulin C-peptide or HbA1C possibly indicating type 2 diabetes abnormal lipid profile eg high triglycerides or thyroid hormones eg TSH FT4 Incidental finding IF management workflow- Participants will be asked during informed consent if they would like to be re-identified and re-contacted in the event of an incidental finding IF during the course of future research Study participant wishes on the return of IF are documented in the informed consent form utilized by the study team - A list of coded study IDs who have indicated their wish on the return of IF will be provided to the PI- The PI will evaluate the findings with a competent and qualified clinicianhealthcare professional study doctor The PI will confirm against the consent form that the participant had indicated their wishes to be re-identified and re-contacted in the event of an IF If so the study participant will be de-identified by the PI to contact the participant- The PI or hisher study team will re-contact the participant and re-confirm if participant would like to be informed of the IF The IF and its relevant information will be provided to the participant according to their preferred manner either electronically or physical copy They will be advised to seek a medical practitioner for further evaluation to reconfirm the IF In the event that the participant is non-contactable the study team will need to demonstrate and document that reasonable efforts have been made to re-contact the participant or next of kin The PI or hisher study team will document the above in the study records The PI or hisher study team will also update study folder that the loop has been closed
During the entire test session they will have to stay rested and in the laboratory Television and a workspace will be provided for their use if they require At the end of 2 hours of testing they will be free to leave The above 2 test sessions may be scheduled in any order but to be completed no more than 4 weeks apart They will now start the study intervention for the next 12 weeks Depending on which group they are assigned to they will be instructed to consume either 60mg of MA or placebo daily after breakfast for the next 12 weeks They will then be required to come for the third test session 4th visit and fourth test session 5th visit at week 12 after completing the 12 weeks of intervention and repeat the same procedures as per that of the first test session 2nd visit and the second test session 3rd visit respectively The 2 test sessions each at week 0 and 12 may be scheduled within 4 weeks from each time point During the course of the study there is a possibility that we might unintentionally come to know of new information about their health condition from eg the screening blood test etc that are conducted as part of the study These are called incidental findings Incidental findings are findings that have potential health or reproductive importance to research participants like you and are discovered in the course of conducting the study but are unrelated to the purposes objectives or variables of the study These findings may affect your current or future life andor health insurance coverage Examples of potential incidental findings that may be discovered during the course of this study may include but are not limited to greater than normal range of fasting glucose insulin C-peptide or HbA1C possibly indicating type 2 diabetes abnormal lipid profile eg high triglycerides or thyroid hormones eg TSH FT4 Incidental finding IF management workflow- Participants will be asked during informed consent if they would like to be re-identified and re-contacted in the event of an incidental finding IF during the course of future research Study participant wishes on the return of IF are documented in the informed consent form utilized by the study team - A list of coded study IDs who have indicated their wish on the return of IF will be provided to the PI- The PI will evaluate the findings with a competent and qualified clinicianhealthcare professional study doctor The PI will confirm against the consent form that the participant had indicated their wishes to be re-identified and re-contacted in the event of an IF If so the study participant will be de-identified by the PI to contact the participant- The PI or hisher study team will re-contact the participant and re-confirm if participant would like to be informed of the IF The IF and its relevant information will be provided to the participant according to their preferred manner either electronically or physical copy They will be advised to seek a medical practitioner for further evaluation to reconfirm the IF In the event that the participant is non-contactable the study team will need to demonstrate and document that reasonable efforts have been made to re-contact the participant or next of kin The PI or hisher study team will document the above in the study records The PI or hisher study team will also update study folder that the loop has been closed
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