Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06645847
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-14
Brief Title:
Targeting Aging with a Ketone Ester for Function in Frailty
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Double-blind Placebo-controlled Parallel Group Pilot Study to Evaluate the Effect of a Ketone Ester on Muscle and Immune Function in Older Men and Women Who Are At Risk for Strength and Mobility Decline
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TAKEOFF
Brief Summary:
This study aims to find out if a special drink that contains a naturally occurring substance ketones can help to improve strength and general wellness in adults at or over the age of 65 years who are experiencing a slight decline in their physical function
Participation will involve a screening visit and 4 additional study visits over the course of 20 weeks After being assessed for eligibility study participants will be sorted into two groups at random and consume either a ketone drink or placebo drink at home every day for 20 weeks Both study drinks can cause gastro-intestinal side effects in some individuals At all study visits subjects will provide blood samples At three study visits subjects will be asked to complete physical performance tests provide blood stool and urine samples They will also complete questionnaires during three study visits to assess physical function markers of inflammation and other aspects of general well-being
Participation will involve a screening visit and 4 additional study visits over the course of 20 weeks After being assessed for eligibility study participants will be sorted into two groups at random and consume either a ketone drink or placebo drink at home every day for 20 weeks Both study drinks can cause gastro-intestinal side effects in some individuals At all study visits subjects will provide blood samples At three study visits subjects will be asked to complete physical performance tests provide blood stool and urine samples They will also complete questionnaires during three study visits to assess physical function markers of inflammation and other aspects of general well-being
Detailed Description:
Screening Phone and Visit 0
Subjects are screened for eligibility by telephone for major exclusion criteria They then attend a screening visit
At the start of the visit subjects must meet pre-test requirements During this visit consent is obtained followed by a medical history interview a physical assessment and fasting blood samples are collected for screening analysis Subjects who meet all the inclusion and none of the exclusion criteria will be scheduled for a Baseline Visit 1 and at the end of Visit 1 will be randomized into one of the two experimental groups ketone ester or placebo Subjects will be shown and instructed on the use of the equipment for the physical function testing and complete a brief familiarization A 24h diet log will be provided to complete before the next visit A stool collection kit will also be provided along with use instructions to complete 3 days before Baseline visit
Baseline Visit Visit 1- Week 0
Subjects must meet pre-test requirements Changes to the subjects health and medicationsupplement use will be assessed and subjects compliance with inclusionexclusion criteria will be reviewed Fasted blood samples are collected A clean catch urine sample is collected for archiving and additional plasma is banked for future aging biomarker analysis After this a physical assessment will be conducted including vital signs after 5 minutes of rest body weight and waist circumference Investigators will reassess Katzs Activities of Daily Living ADL and Lawtons Instrumental Activities of Daily Living IADLs and CSHA Frailty Score Canadian Study of Health and Aging Then subjects will complete the following paper questionnaires Profile of Mood States Short form Short Form Health Survey-36 Pittsburgh Sleep Quality Index Pittsburgh Fatiguability Scale Geriatric Depression Scale Lower Urinary Tract Symptom Questionnaire Subjects will complete cognitive function testing Montreal Cognitive Assessment Digit Symbol Substitution Task and Trails A and B Subjects will complete physical function testing Short Physical Performance Battery 1 rep max leg press sub maximal leg press repetitions to failure 6-minute walk test and grip strength Subjects will be given a stool sample collection kit to take home for at-home sample between Week 0 and 1 samples are returned by mail Subject will be given a months supply of study product to take home Subjects will be reminded of study instructions for study beverage consumption daily Study Log completion and to maintain habitual exercise mealdiet and medicationsupplementation use Subjects will be given a wearable actigraphy device and instructed on its use during the study
At home procedures Week 0 - 20
Each day at home subjects should consume their first meal of the day at a similar time and consume the study product within 5 minutes of finishing their first meal For the first 7 days of the study subjects will consume 375 mL of study product measured in a provided measuring cup From day 8 onwards subjects will consume 75 mL of study product measured in a provided measuring cup From Week 3 onwards they will consume a second serving Week 3 375 mL Week 4 - 20 75 mL within 5 minutes of finishing their final meal of the day Subjects will complete the Study Log to confirm they consumed their study product The Study Log will query the presence of specific symptoms in the hours after consumption of the study product with a beverage tolerance questionnaire BTQ Between days 6 - 9 subjects will collect a stool sample using the provided kit
Every 2 weeks excepting the site visits the subjects will schedule a phone call with the Study Team in which they will verbally complete the BTQ for symptoms occurring in the preceding 2-week period Compliance will be assessed and AEs will also be assessed with an open-ended question Subjects will be reminded of study instructions for study beverage consumption daily Study Log completion and to maintain habitual exercise mealdiet and medicationsupplementation use After Week 16 check in subjects will be mailed a stool sample collection kit for sample collection up to 3 days ahead of Visit 4
From Week 5 onwards a full BTQ is not completed daily There is space in the Study Log to note any symptoms these notes will be used to assess tolerance by interview for the previous 2-week interval at Visit 2 during phone check-ins Week 2 6 8 10 14 16 and 18 and at Visits 3 and 4 Study product will be provided at one month intervals it will be distributed directly during Visit 2 week 4 and Visit 3 week 12 and it will be shipped to subjects homes to arrive in week 8 and 16
Intermediate Visit Visit 2- Week 4 Subjects must meet pre-test requirements on arrival for Visit 2 fasting 10 h no alcohol 10 h no exercise 10 h no cannabis products 10 h a reminder email or telephone call if preferred by the subject will be sent out ahead of the visit On arrival changes to medicationsupplement use will be assessed and the subjects compliance with inclusionexclusion criteria will be reviewed Subjects will be queried to ensure compliance with study instructions Subjects will be asked to provide any unused product to assess compliance of Study Product consumption and the Study Log Part I will be reviewed and collected Adherence will be assessed and adverse events AEs will also be assessed with an open-ended question After this a physical assessment will be conducted including vital signs after 5 minutes of rest body weight body composition using bioelectrical impedance and waist circumference Fasting blood samples will be collected for the following analysis clinical chemistry lipid panel hematology and liver function Additional samples will be retained to bank for possible future mechanistic investigations Then subjects will be asked to collect a urine sample for archiving Subjects will verbally complete the BTQ for symptoms occurring in the preceding 2-week period
Subjects will be reminded of study instructions for study beverage consumption daily Study Log completion and to maintain habitual exercise mealdiet and medicationsupplementation use Subjects will be given a stool sample collection kit instructions insert shown in Appendix to take home for at-home sample collection up to 3 days after Visit 2 the stool sample will be returned to investigators using a prepaid mailer Finally subjects will be given a 4-week supply of study beverages to take home and Study Log Part II On this day subjects will be asked to consume study products with their next meal after the test visit is complete
Visit 3 Interim Endpoints Visit Visit 4 - Week 12 and Final Visit Visit 5- Week 20
Follows identical testing procedures to Baseline Visit Visit 3- Week 0
Subjects are screened for eligibility by telephone for major exclusion criteria They then attend a screening visit
At the start of the visit subjects must meet pre-test requirements During this visit consent is obtained followed by a medical history interview a physical assessment and fasting blood samples are collected for screening analysis Subjects who meet all the inclusion and none of the exclusion criteria will be scheduled for a Baseline Visit 1 and at the end of Visit 1 will be randomized into one of the two experimental groups ketone ester or placebo Subjects will be shown and instructed on the use of the equipment for the physical function testing and complete a brief familiarization A 24h diet log will be provided to complete before the next visit A stool collection kit will also be provided along with use instructions to complete 3 days before Baseline visit
Baseline Visit Visit 1- Week 0
Subjects must meet pre-test requirements Changes to the subjects health and medicationsupplement use will be assessed and subjects compliance with inclusionexclusion criteria will be reviewed Fasted blood samples are collected A clean catch urine sample is collected for archiving and additional plasma is banked for future aging biomarker analysis After this a physical assessment will be conducted including vital signs after 5 minutes of rest body weight and waist circumference Investigators will reassess Katzs Activities of Daily Living ADL and Lawtons Instrumental Activities of Daily Living IADLs and CSHA Frailty Score Canadian Study of Health and Aging Then subjects will complete the following paper questionnaires Profile of Mood States Short form Short Form Health Survey-36 Pittsburgh Sleep Quality Index Pittsburgh Fatiguability Scale Geriatric Depression Scale Lower Urinary Tract Symptom Questionnaire Subjects will complete cognitive function testing Montreal Cognitive Assessment Digit Symbol Substitution Task and Trails A and B Subjects will complete physical function testing Short Physical Performance Battery 1 rep max leg press sub maximal leg press repetitions to failure 6-minute walk test and grip strength Subjects will be given a stool sample collection kit to take home for at-home sample between Week 0 and 1 samples are returned by mail Subject will be given a months supply of study product to take home Subjects will be reminded of study instructions for study beverage consumption daily Study Log completion and to maintain habitual exercise mealdiet and medicationsupplementation use Subjects will be given a wearable actigraphy device and instructed on its use during the study
At home procedures Week 0 - 20
Each day at home subjects should consume their first meal of the day at a similar time and consume the study product within 5 minutes of finishing their first meal For the first 7 days of the study subjects will consume 375 mL of study product measured in a provided measuring cup From day 8 onwards subjects will consume 75 mL of study product measured in a provided measuring cup From Week 3 onwards they will consume a second serving Week 3 375 mL Week 4 - 20 75 mL within 5 minutes of finishing their final meal of the day Subjects will complete the Study Log to confirm they consumed their study product The Study Log will query the presence of specific symptoms in the hours after consumption of the study product with a beverage tolerance questionnaire BTQ Between days 6 - 9 subjects will collect a stool sample using the provided kit
Every 2 weeks excepting the site visits the subjects will schedule a phone call with the Study Team in which they will verbally complete the BTQ for symptoms occurring in the preceding 2-week period Compliance will be assessed and AEs will also be assessed with an open-ended question Subjects will be reminded of study instructions for study beverage consumption daily Study Log completion and to maintain habitual exercise mealdiet and medicationsupplementation use After Week 16 check in subjects will be mailed a stool sample collection kit for sample collection up to 3 days ahead of Visit 4
From Week 5 onwards a full BTQ is not completed daily There is space in the Study Log to note any symptoms these notes will be used to assess tolerance by interview for the previous 2-week interval at Visit 2 during phone check-ins Week 2 6 8 10 14 16 and 18 and at Visits 3 and 4 Study product will be provided at one month intervals it will be distributed directly during Visit 2 week 4 and Visit 3 week 12 and it will be shipped to subjects homes to arrive in week 8 and 16
Intermediate Visit Visit 2- Week 4 Subjects must meet pre-test requirements on arrival for Visit 2 fasting 10 h no alcohol 10 h no exercise 10 h no cannabis products 10 h a reminder email or telephone call if preferred by the subject will be sent out ahead of the visit On arrival changes to medicationsupplement use will be assessed and the subjects compliance with inclusionexclusion criteria will be reviewed Subjects will be queried to ensure compliance with study instructions Subjects will be asked to provide any unused product to assess compliance of Study Product consumption and the Study Log Part I will be reviewed and collected Adherence will be assessed and adverse events AEs will also be assessed with an open-ended question After this a physical assessment will be conducted including vital signs after 5 minutes of rest body weight body composition using bioelectrical impedance and waist circumference Fasting blood samples will be collected for the following analysis clinical chemistry lipid panel hematology and liver function Additional samples will be retained to bank for possible future mechanistic investigations Then subjects will be asked to collect a urine sample for archiving Subjects will verbally complete the BTQ for symptoms occurring in the preceding 2-week period
Subjects will be reminded of study instructions for study beverage consumption daily Study Log completion and to maintain habitual exercise mealdiet and medicationsupplementation use Subjects will be given a stool sample collection kit instructions insert shown in Appendix to take home for at-home sample collection up to 3 days after Visit 2 the stool sample will be returned to investigators using a prepaid mailer Finally subjects will be given a 4-week supply of study beverages to take home and Study Log Part II On this day subjects will be asked to consume study products with their next meal after the test visit is complete
Visit 3 Interim Endpoints Visit Visit 4 - Week 12 and Final Visit Visit 5- Week 20
Follows identical testing procedures to Baseline Visit Visit 3- Week 0
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None