Ignite Creation Date:
2024-05-06 @ 6:49 PM
Last Modification Date:
2024-10-26 @ 2:55 PM
Study NCT ID:
NCT05794802
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-04-10
First Post:
2023-03-20
Brief Title:
Ketone Monoester and Blood Pressure
Sponsor:
Université de Sherbrooke
Organization:
Université de Sherbrooke
Study Overview
Official Title:
The Effect of Acute Exogenous Oral Ketone Supplementation on Diurnal and Nocturnal Blood Pressure and Glucose Homeostasis
Status:
NOT_YET_RECRUITING
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:
BHB
Brief Summary:
The goal of this clinical trial is to determine the effect of acute consumption of a ketone monoester supplement in healthy male adults
The main questions it aims to answer are
To determine if acute consumption of a ketone monoester supplement modulates diurnal measured in lab and nocturnal blood pressure assessed by ambulatory blood pressure monitoring ABPM compared to a taste-matched placebo The investigators hypothesize that a ketone monoester supplement will acutely decrease systolic and diastolic blood pressure compared to the placebo The same results are expected for diurnal and nocturnal blood pressure
To determine if acute consumption of a ketone monoester supplement improves glucose control measured with continuous glucose monitoring CGM following a standardized meal consumed 90 minutes after ingestion of the ketone supplement The investigators hypothesize that a ketone monoester supplement consumed 90 minutes before a meal will decrease the 2-hour postprandial glucose incremental area under the curve iAUC and peak glucose compared to a placebo
To assess IL-10s ability to inhibit proinflammatory cytokine production TNF- α and IL-1β in LPS-stimulated whole blood cultures following the ingestion of β-OHB and placebo The investigators hypothesize that β-OHB will augment the ability of IL-10 to inhibit TNF-α and IL-1β production compared to placebo
Using a double-blind placebo-controlled randomized crossover study design 15 adults will participate in two experimental conditions Participants will be recruited using a local recruitment database Nabû during presentations in community organizations with posters at the University of Sherbrooke and from word of mouth
Following screening eligible participants will be invited for one baseline and two experimental conditions at the Research Centre on Aging CdRV During the baseline visit the following assessments and tests will be conducted
resting heart rate HR and blood pressure
anthropometry and body composition
medical history and questionnaires on physical activity levels dietary habits and anxiety symptoms
explanation of the dietary and physical activity logs
installation of accelerometers to control physical activity levels and sedentary behaviors over 10 days and CGM to assess glucose control over the subsequent 10 consecutive days
During the week following the baseline condition participants will be invited to the laboratory for their first experimental condition duration 240 minutes Participants will come to the lab in a fasted state at least 12-hour overnight to the lab at 800 am where following assessments and tests will be conducted
resting heart rate HR and blood pressure
ketone supplement or placebo consumption
blood samples and cold pressor test
standardized breakfast
galvanic skin response
visual analog scales assessing gastrointestinal discomfort hunger and fullness
installation of ABPM and explanation of the dietary and physical activity logs
Forty-eight hours later participants will complete the same experimental condition with the alternate supplement ketone or placebo according to their randomization
The main questions it aims to answer are
To determine if acute consumption of a ketone monoester supplement modulates diurnal measured in lab and nocturnal blood pressure assessed by ambulatory blood pressure monitoring ABPM compared to a taste-matched placebo The investigators hypothesize that a ketone monoester supplement will acutely decrease systolic and diastolic blood pressure compared to the placebo The same results are expected for diurnal and nocturnal blood pressure
To determine if acute consumption of a ketone monoester supplement improves glucose control measured with continuous glucose monitoring CGM following a standardized meal consumed 90 minutes after ingestion of the ketone supplement The investigators hypothesize that a ketone monoester supplement consumed 90 minutes before a meal will decrease the 2-hour postprandial glucose incremental area under the curve iAUC and peak glucose compared to a placebo
To assess IL-10s ability to inhibit proinflammatory cytokine production TNF- α and IL-1β in LPS-stimulated whole blood cultures following the ingestion of β-OHB and placebo The investigators hypothesize that β-OHB will augment the ability of IL-10 to inhibit TNF-α and IL-1β production compared to placebo
Using a double-blind placebo-controlled randomized crossover study design 15 adults will participate in two experimental conditions Participants will be recruited using a local recruitment database Nabû during presentations in community organizations with posters at the University of Sherbrooke and from word of mouth
Following screening eligible participants will be invited for one baseline and two experimental conditions at the Research Centre on Aging CdRV During the baseline visit the following assessments and tests will be conducted
resting heart rate HR and blood pressure
anthropometry and body composition
medical history and questionnaires on physical activity levels dietary habits and anxiety symptoms
explanation of the dietary and physical activity logs
installation of accelerometers to control physical activity levels and sedentary behaviors over 10 days and CGM to assess glucose control over the subsequent 10 consecutive days
During the week following the baseline condition participants will be invited to the laboratory for their first experimental condition duration 240 minutes Participants will come to the lab in a fasted state at least 12-hour overnight to the lab at 800 am where following assessments and tests will be conducted
resting heart rate HR and blood pressure
ketone supplement or placebo consumption
blood samples and cold pressor test
standardized breakfast
galvanic skin response
visual analog scales assessing gastrointestinal discomfort hunger and fullness
installation of ABPM and explanation of the dietary and physical activity logs
Forty-eight hours later participants will complete the same experimental condition with the alternate supplement ketone or placebo according to their randomization
Detailed Description:
The goal of this clinical trial is to determine the effect of acute consumption of a ketone monoester supplement in healthy male adults
The main questions it aims to answer are
To determine if acute consumption of a ketone monoester supplement modulates diurnal measured in lab and nocturnal blood pressure assessed by ambulatory blood pressure monitoring ABPM compared to a taste-matched placebo The investigators hypothesize that a ketone monoester supplement will acutely decrease systolic and diastolic blood pressure compared to the placebo The same results are expected for diurnal and nocturnal blood pressure
To determine if acute consumption of a ketone monoester supplement improves glucose control measured with continuous glucose monitoring CGM following a standardized meal consumed 90 minutes after ingestion of the ketone supplement The investigators hypothesize that a ketone monoester supplement consumed 90 minutes before a meal will decrease the 2-hour postprandial glucose incremental area under the curve iAUC and peak glucose compared to a placebo
To assess IL-10s ability to inhibit proinflammatory cytokine production TNF- α and IL-1β in LPS-stimulated whole blood cultures following the ingestion of β-OHB and placebo The investigators hypothesize that β-OHB will augment the ability of IL-10 to inhibit TNF-α and IL-1β production compared to placebo
Using a double-blind placebo-controlled randomized crossover study design 15 adults will participate in two experimental conditions Participants will be recruited using a local recruitment database Nabû during presentations in community organizations with posters at the University of Sherbrooke and from word of mouth Following screening eligible participants will be invited for one baseline and two experimental conditions at the Research Centre on Aging CdRV During the baseline visit the following assessments and tests will be conducted 1 resting heart rate HR and blood pressure 2 anthropometry and body composition 3 medical history and questionnaires on physical activity levels dietary habits and anxiety symptoms 4 explanation of the dietary and physical activity logs 5 installation of accelerometers to control physical activity levels and sedentary behaviours over 10 days and CGM to assess glucose control over the subsequent 10 consecutive days Informed consent will be obtained from all participants involved in the study before participating in any assessments or tests The participant will then be invited to our lab for two non-consecutive days for the experimental condition at least 48 hours apart
The first visit will take place at the CdRV Sherbrooke QC on a Thursday or Friday morning Once the informed consent has been obtained a medical history and a physical activity questionnaire International Physical Activity Questionnaire will be completed by the participant Body weight height and waist circumference will then be measured using standardized procedures Body composition will be assessed using Dual Energy X-ray absorptiometry DXA A CGM will be installed at the abdominal region by the participant himself with the supervision of an experienced exercise physiologist To limit compensatory behaviours in response to observed blood glucose levels CGM will be blinded to participants Finally participants will be outfitted with a thigh-worn activPAL4 and a hip-worn ActiGraph wGT3X-BT accelerometer to wear for the following 10 days Wearing the accelerometers will allow for comparing physical activity levels and sedentary behaviours on the days before and after each condition To ensure that both accelerometers provide reliable data standardized tests will be performed in our laboratory during the baseline condition While wearing the activPAL4 and ActiGraph participants will walk on the treadmill Life Fitness Club Series FlexDeck Rosemont IL USA at 30 50 and 70 kmh for 6 minutes at each intensity Participants will also have to be in a seated recline and lying position for 5 minutes each and perform non-ambulatory tasks washing dishes - 6 minutes and setting the table - 3 minutes All participants will wear the Xsens motion system during these tasks to capture movement and inform us of the activity profile for better data analysis
During the week following the baseline visit participants will be invited to the CdRV for the first experimental condition duration 240 minutes Participants will come to the lab in a fasted state at least 12-hour overnight to the lab at 800 am where resting blood pressure will be measured in a standardized manner HR will be continuously monitored for the duration of the visit in the lab from 800 am to 1200 pm using a heart rate monitor Polar H10 Kempele Finland At 820 am blood samples will be collected by a certified research nurse A total of 35 mL of blood will be collected in EDTA tubes for whole blood culture and CPT sodium heparin tubes for PBMC isolation and subsequent transcriptomic analyses Capillary β-OHB levels will be measured using the Abbot Freestyle Precision Neo ketone meter before the ingestion of the ketone monoester supplement drink or the taste-matched placebo At 830 am participants will be allowed 2 minutes to consume the oral ketone supplement or placebo drink liquid form 80 - 120 mL depending on to the participants body weight β-OHB concentration will then be measured at 30 60 and 90 minutes after ingestion 900 930 and 1000 am Participants will remain seated for 90 minutes following ingestion of the ketone supplement while standardized blood pressure measures will be performed every 20 minutes At 930 am ie 60 minutes after β-OHB ingestion another blood sample collection will be done 25 mL Five minutes after the blood sample collection and right before the blood pressure challenge ie cold pressor test resting blood pressure and HR will be measured The cold pressor test will allow the evaluation of the vascular response following an external stressor in a controlled setting which can occur in everyday life following the consumption of β-OHB
Ninety minutes after ketone or placebo ingestion participants will consume a standardized breakfast consisting of a meal replacement drink granola bars and orange juice which is representative of a realistic mixed meal MMTT and provides 490 kcal 68g CHO 12g FAT 29g PRO 55 22 and 23 respectively Participants will then remain seated for 120 minutes after the MMTT to assess glucose response CGM in the postprandial state and blood pressure will be measured every 20 minutes Additionally participants will be asked to complete visual analog scales assessing gastrointestinal GI discomfort at -10 0 30 60 and 90 minutes after ketone supplement consumption to monitor for GI distress Participants will also be asked to complete visual analog scales for hunger and fullness at -10 0 60 and 90 minutes after the standardized meal At 1200 pm participants will then be outfitted with the ABPM IEM PWA Mobil-o-graph IEM GmbH Germany on the non-dominant arm with the appropriate cuff size as suggested by the manufacturer Participants will also receive instructions on how to fill the logbook which asks participants to record bedtime hours physical activity and sleep quality assessed via a visual analogue scale Nutritional intake will be estimated by using the Keenoa app
Another ketone supplement or placebo drink will be provided to consume directly before going to bed
Participants will be asked to refrain from structured exercise alcohol and caffeine consumption limit physical activity to their activities of daily living on the day before and during each trial and replicate their dietary intake 24 hours before and 24 hours after both experimental visits Furthermore participants will also be asked to refrain from taking any medications that could affect glucose metabolism or blood pressure and any short-term analgesics acetaminophen ibuprofen etc While being conducted in free-living settings standardizing the experimental conditions as outlined above will allow for controlling any potentially confounding factors between both conditions that could affect our variables of interest and therefore improve measurement rigour
Forty-eight hours later participants will complete the same experimental condition with the alternate supplement ketone or placebo according to their randomization
The main questions it aims to answer are
To determine if acute consumption of a ketone monoester supplement modulates diurnal measured in lab and nocturnal blood pressure assessed by ambulatory blood pressure monitoring ABPM compared to a taste-matched placebo The investigators hypothesize that a ketone monoester supplement will acutely decrease systolic and diastolic blood pressure compared to the placebo The same results are expected for diurnal and nocturnal blood pressure
To determine if acute consumption of a ketone monoester supplement improves glucose control measured with continuous glucose monitoring CGM following a standardized meal consumed 90 minutes after ingestion of the ketone supplement The investigators hypothesize that a ketone monoester supplement consumed 90 minutes before a meal will decrease the 2-hour postprandial glucose incremental area under the curve iAUC and peak glucose compared to a placebo
To assess IL-10s ability to inhibit proinflammatory cytokine production TNF- α and IL-1β in LPS-stimulated whole blood cultures following the ingestion of β-OHB and placebo The investigators hypothesize that β-OHB will augment the ability of IL-10 to inhibit TNF-α and IL-1β production compared to placebo
Using a double-blind placebo-controlled randomized crossover study design 15 adults will participate in two experimental conditions Participants will be recruited using a local recruitment database Nabû during presentations in community organizations with posters at the University of Sherbrooke and from word of mouth Following screening eligible participants will be invited for one baseline and two experimental conditions at the Research Centre on Aging CdRV During the baseline visit the following assessments and tests will be conducted 1 resting heart rate HR and blood pressure 2 anthropometry and body composition 3 medical history and questionnaires on physical activity levels dietary habits and anxiety symptoms 4 explanation of the dietary and physical activity logs 5 installation of accelerometers to control physical activity levels and sedentary behaviours over 10 days and CGM to assess glucose control over the subsequent 10 consecutive days Informed consent will be obtained from all participants involved in the study before participating in any assessments or tests The participant will then be invited to our lab for two non-consecutive days for the experimental condition at least 48 hours apart
The first visit will take place at the CdRV Sherbrooke QC on a Thursday or Friday morning Once the informed consent has been obtained a medical history and a physical activity questionnaire International Physical Activity Questionnaire will be completed by the participant Body weight height and waist circumference will then be measured using standardized procedures Body composition will be assessed using Dual Energy X-ray absorptiometry DXA A CGM will be installed at the abdominal region by the participant himself with the supervision of an experienced exercise physiologist To limit compensatory behaviours in response to observed blood glucose levels CGM will be blinded to participants Finally participants will be outfitted with a thigh-worn activPAL4 and a hip-worn ActiGraph wGT3X-BT accelerometer to wear for the following 10 days Wearing the accelerometers will allow for comparing physical activity levels and sedentary behaviours on the days before and after each condition To ensure that both accelerometers provide reliable data standardized tests will be performed in our laboratory during the baseline condition While wearing the activPAL4 and ActiGraph participants will walk on the treadmill Life Fitness Club Series FlexDeck Rosemont IL USA at 30 50 and 70 kmh for 6 minutes at each intensity Participants will also have to be in a seated recline and lying position for 5 minutes each and perform non-ambulatory tasks washing dishes - 6 minutes and setting the table - 3 minutes All participants will wear the Xsens motion system during these tasks to capture movement and inform us of the activity profile for better data analysis
During the week following the baseline visit participants will be invited to the CdRV for the first experimental condition duration 240 minutes Participants will come to the lab in a fasted state at least 12-hour overnight to the lab at 800 am where resting blood pressure will be measured in a standardized manner HR will be continuously monitored for the duration of the visit in the lab from 800 am to 1200 pm using a heart rate monitor Polar H10 Kempele Finland At 820 am blood samples will be collected by a certified research nurse A total of 35 mL of blood will be collected in EDTA tubes for whole blood culture and CPT sodium heparin tubes for PBMC isolation and subsequent transcriptomic analyses Capillary β-OHB levels will be measured using the Abbot Freestyle Precision Neo ketone meter before the ingestion of the ketone monoester supplement drink or the taste-matched placebo At 830 am participants will be allowed 2 minutes to consume the oral ketone supplement or placebo drink liquid form 80 - 120 mL depending on to the participants body weight β-OHB concentration will then be measured at 30 60 and 90 minutes after ingestion 900 930 and 1000 am Participants will remain seated for 90 minutes following ingestion of the ketone supplement while standardized blood pressure measures will be performed every 20 minutes At 930 am ie 60 minutes after β-OHB ingestion another blood sample collection will be done 25 mL Five minutes after the blood sample collection and right before the blood pressure challenge ie cold pressor test resting blood pressure and HR will be measured The cold pressor test will allow the evaluation of the vascular response following an external stressor in a controlled setting which can occur in everyday life following the consumption of β-OHB
Ninety minutes after ketone or placebo ingestion participants will consume a standardized breakfast consisting of a meal replacement drink granola bars and orange juice which is representative of a realistic mixed meal MMTT and provides 490 kcal 68g CHO 12g FAT 29g PRO 55 22 and 23 respectively Participants will then remain seated for 120 minutes after the MMTT to assess glucose response CGM in the postprandial state and blood pressure will be measured every 20 minutes Additionally participants will be asked to complete visual analog scales assessing gastrointestinal GI discomfort at -10 0 30 60 and 90 minutes after ketone supplement consumption to monitor for GI distress Participants will also be asked to complete visual analog scales for hunger and fullness at -10 0 60 and 90 minutes after the standardized meal At 1200 pm participants will then be outfitted with the ABPM IEM PWA Mobil-o-graph IEM GmbH Germany on the non-dominant arm with the appropriate cuff size as suggested by the manufacturer Participants will also receive instructions on how to fill the logbook which asks participants to record bedtime hours physical activity and sleep quality assessed via a visual analogue scale Nutritional intake will be estimated by using the Keenoa app
Another ketone supplement or placebo drink will be provided to consume directly before going to bed
Participants will be asked to refrain from structured exercise alcohol and caffeine consumption limit physical activity to their activities of daily living on the day before and during each trial and replicate their dietary intake 24 hours before and 24 hours after both experimental visits Furthermore participants will also be asked to refrain from taking any medications that could affect glucose metabolism or blood pressure and any short-term analgesics acetaminophen ibuprofen etc While being conducted in free-living settings standardizing the experimental conditions as outlined above will allow for controlling any potentially confounding factors between both conditions that could affect our variables of interest and therefore improve measurement rigour
Forty-eight hours later participants will complete the same experimental condition with the alternate supplement ketone or placebo according to their randomization
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