Overweight and ObesityNCT04907110
NR Supplementation and Exercise
A study testing Niagen and Exercise in people with Overweight and Obesity and Aging, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
The number of age-related chronic diseases (like obesity, type 2 diabetes and cardiovascular diseases) is increasing rapidly worldwide, reaching pandemic proportions. These age-related chronic diseases are associated with metabolic disturbances and mitochondrial dysfunction in humans. Read more about this study
- Who is it for?
- Ages 65 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity, Aging, Type 2 Diabetes
- What is being tested?
- Niagen and Exercise
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteNetherlands
- Study dates
- 10 Aug 2021to 7 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 80 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Participants are able to provide signed and dated written informed consent prior to any study specific procedures
- Aged ≥ 65 and ≤ 80 years
- Body mass index (BMI) 25 - 35 kg/m2
- Stable dietary habits (no weight loss or gain > 5 kg in the past 3 months)
- No signs of active cardiovascular disease, liver or kidney malfunction
Who cannot join
- Type 2 diabetes
- Patients with congestive heart failure and and/or severe renal and or liver insufficiency
- Uncontrolled hypertension
- Any contra-indication for MRI scanning
- Alcohol consumption of >3 servings per day for man and >2 servings per day for woman
- Smoking
Show all 12Show fewer
- Unstable body weight (weight gain or loss > 5kg in the last 3 months)
- Engagement in structured exercise activities > 2 hours a week
- Previous enrolment in a clinical study with an investigational product during the last 3 months or as judged by the Investigator which would possibly hamper our study results
- Medication use known to hamper subject's safety during the study procedures
- Subjects who do not want to be informed about unexpected medical findings
- Use of food supplements containing NR or Resveratrol (similar working mechanisms)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Exercise Training Combined With NR Supplementation on Metabolic Health in Older Individuals
The number of age-related chronic diseases (like obesity, type 2 diabetes and cardiovascular diseases) is increasing rapidly worldwide, reaching pandemic proportions. These age-related chronic diseases are associated with metabolic disturbances and mitochondrial dysfunction in humans. Nicotinamide adenosine dinucleotide (NAD) levels play an important role in energy metabolism and mitochondrial functioning and indeed it has been shown that high concentrations of NAD+ as well as a high NAD+/NADH ratio are strongly associated with metabolic and mitochondrial health. In contrast, decreased NAD+ bioavailability is reported in both ageing and obese humans as well as in diabetic mice. These findings fueled the idea of influencing NAD+ bioavailability in order to improve metabolic disturbances and mitochondrial dysfunction in humans. Supplementation with nicotinamide riboside (NR), a naturally occurring form of vitamin B3, may provide a way to boost cellular NAD+ levels. However, in contrast to animal studies, NR supplementation in humans has so far been unsuccessful in improving skeletal muscle mitochondrial function, exercise capacity or insulin sensitivity. Recently, it has been suggested that a situation where NAD+ levels become limited, is needed for NR supplementation to exert beneficial health effects. This situation could be achieved by combining exercise and NR supplementation. However, studies combining NR and exercise are lacking, which is why we would like to perform such a study here.
Read the detailed description
Rationale: The number of age-related chronic diseases (like obesity, type 2 diabetes and cardiovascular diseases) is increasing rapidly worldwide, reaching pandemic proportions. These age-related chronic diseases are associated with metabolic disturbances and mitochondrial dysfunction in humans. Nicotinamide adenosine dinucleotide (NAD) levels play an important role in energy metabolism and mitochondrial functioning and indeed it has been shown that high concentrations of NAD+ as well as a high NAD+/NADH ratio are strongly associated with metabolic and mitochondrial health. In contrast, decreased NAD+ bioavailability is reported in both ageing and obese humans as well as in diabetic mice. These findings fueled the idea of influencing NAD+ bioavailability in order to improve metabolic disturbances and mitochondrial dysfunction in humans. Supplementation with nicotinamide riboside (NR), a naturally occurring form of vitamin B3, may provide a way to boost cellular NAD+ levels. However, in contrast to animal studies, NR supplementation in humans has so far been unsuccessful in improving skeletal muscle mitochondrial function, exercise capacity or insulin sensitivity. Recently, it has been suggested that a situation where NAD+ levels become limited, is needed for NR supplementation to exert beneficial health effects. This situation could be achieved by combining exercise and NR supplementation. However, studies combining NR and exercise are lacking, which is why we would like to perform such a study here.
Objective: The primary objective of this study is to determine whether combined treatment of exercise and NR imposes greater improvements in skeletal muscle mitochondrial metabolism in older humans compared to exercise treatment alone. The secondary objective is to determine whether combined treatment of exercise and NR supplementation imposes greater improvements in sleeping metabolic rate (SMR). As explorative objectives, we will examine whether combined treatment with exercise and NR imposes greater improvements in muscle (NAD) metabolites, energy metabolism and physical performance.
Study design: The present study is a randomized, double-blinded, placebo-controlled double arm longitudinal intervention study in a pre and post design.
Study population: 30 older male and (postmenopausal) female participants, aged 65 - 80 years with a BMI between 25-35 kg/m2 will perform this study (15 participants in the exercise+placebo group, 15 participants in the exercise+NR group). From experience with similar studies, we estimate a drop-out rate of 20% and a screening failure of 50% (due to the strict inclusion criteria), resulting in maximally 36 subjects that have to be included and 72 subjects that have to be screened (maximally).
Intervention (if applicable): Participants will be asked to take two pills of NR (250mg/pill), or placebo, twice daily (two with breakfast and two with diner, a total of 4 pills/day; 1000mg/day), for 40 days. During days 17-38 of the NR intervention, participants will perform a 3-weeks supervised exercise training program with four ~30 min exercise sessions per week (two endurance session on a bike at 70%Wmax and two high intensity interval (HIIT) sessions. Participants will be randomly assigned to the placebo + exercise or NR + exercise arm. To assess the outcomes, participants will undergo three test days before the start of the NR supplementation and repeat these three test days at the end (day 38-40) of NR supplementation.
Main study parameters/endpoints: The primary study endpoints is ex vivo skeletal muscle mitochondrial function measured via high-resolution respirometry. Explorative objectives are muscle (NAD) metabolites, energy metabolism and physical performance.
- Conditions
- Overweight and Obesity, Aging, Type 2 Diabetes
- Being tested
- Niagen, Exercise
- Keywords
- exercise, NR supplementation, NAD metabolism
- Medical subject headings
- Overweight, Obesity, Diabetes Mellitus, Type 2, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NiagenDietary supplement
Also called Nicotinamide Riboside (NR)
Participants in the NR supplementation + exercise group will undergo oral NR supplementation for 40 days. NiagenTM is the name for the dietary supplement containing NR (ChromaDex, Inc. Irvine, USA). The total dosage of NR per day will be 1000mg. This supplementation time of 40 days 1000mg/day
ExerciseOther
During days 17-38 of the NR/placebo intake, participants will perform a 3-weeks supervised exercise training program with four ~30 min exercise sessions per week (two endurance session on a bike at 70%Wmax and two high intensity interval (HIIT) sessions.
| Study group | Role | What they receive |
|---|---|---|
| Exercise + NR | Experimental | Participants will be asked to take two pills of NR (250mg/pill) twice daily (a total of 4 pills/day; 1000mg/day), for 40 days. During days 17-38 of the NR intervention, participants will perform a 3-weeks supervised exercise training program with four ~30 min exercise sessions per week (two endurance session on a bike at 70%Wmax and two high intensity interval (HIIT) sessions. To assess the outcomes, participants will undergo three test days before the start of the NR supplementation and repeat these three test days at the end (day 38-40) of NR supplementation. Receives: Dietary Supplement: Niagen; Other: Exercise |
| Exercise + Placebo | Placebo comparator | Participants will be asked to take two pills of placebo, twice daily (a total of 4 pills/day), for 40 days. During days 17-38 of the intervention, participants will perform a 3-weeks supervised exercise training program with four ~30 min exercise sessions per week (two endurance session on a bike at 70%Wmax and two high intensity interval (HIIT) sessions. To assess the outcomes, participants will undergo three test days before the start of the NR supplementation and repeat these three test days at the end (day 38-40) of the placebo supplementation. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ex vivo muscle mitochondrial function
Ex vivo mitochondrial function in skeletal muscle measured by oxygen consumption in muscle fibres (muscle biopsy vastus lateralis) on lipid-derived and carbohydrate-derived substrates.
Measured: Pre-intervention test day 3 + day 40 of the intervention NR/Placebo + exercise
Secondary outcomes (12)
Maximal aerobic capacity
Maximal aerobic capacity measured during a VO2max cycling test in ml/kg/min
Measured: Pre-intervention test day 1 + Day 38
Physical performance
Physical performance is measured during a 6-minute walk test (6MWT) expressed as the distance covered during 6 minutes walking as well as the time necessary to stand up from a chair (TCST).
Measured: Pre-intervention test day 1 + Day 38
Skeletal muscle NAD concentrations (ex-vivo)
Skeletal muscle NAD metabolites are measured in muscle biopsies using metabolomics
Measured: Pre-intervention test day 3 + Day 40
Skeletal muscle NAD concentration (in-vivo)
Skeletal muscle NAD metabolites are measured in vivo using phosphorus magnetic resonance spectroscopy in the m. vastus lateralis.
Measured: Pre-intervention test day 3 + Day 40
Intrahepatic lipid content
Intrahepatic lipid content is measured using proton magnetic resonance spectroscopy
Measured: Pre-intervention test day 1 + Day 38
Upper leg muscle mass
Upper leg muscle mass is measured with magnetic resonance imaging
Measured: Pre-intervention test day 1 + Day 38
Body composition
Body composition is measured using the BodPod technique and fat mass (kg and %) and fat-free mass (kg) will be determined.
Measured: Pre-intervention test day 1 + Day 38
Quality of life
Quality of life will be assessed by a questionnaire (in arbitrary units measured via the 32-item survey)
Measured: Pre-intervention test day 1 + Day 38
Blood metabolites
Metabolites in the blood (i.e. glucose, free fatty acids, triglycerides, cholesterol, insulin in mmol/L taken via a venepuncture)
Measured: Pre-intervention test day 3 + Day 40
Submaximal exercise energy expenditure
Submaximal exercise energy expenditure will be measured via indirect calorimetry during a 60-minute submaximal cycling exercise at 50% Wmax
Measured: Pre-intervention test day 3 + Day 40
Sleeping metabolic rate
Sleeping metabolic rate will be measured during a 11 hour stay in a respiration chamber via indirect calorimetry
Measured: Pre-intervention test day 2 + Day 39
Exercise efficiency
Exercise efficiency will be measured during a 60-minute submaximal cycling test via indirect calorimetry in kJ/min
Measured: Pre-intervention test day 3 + Day 40
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2021
- Study start10 Aug 2021
- Primary completion2 Dec 2022
- Study completion7 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The present study is a randomized, double-blinded, placebo-controlled double arm longitudinal intervention study in a pre and post design.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04907110
- Sponsor's protocol ID
- NL77756.068.21
- Status last verified
- Feb 2023
- First submitted
- 25 May 2021
- Last updated
- 10 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data can be obtained with the principal investigator if desired.
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Exercise Training Combined With NR Supplementation on Metabolic Health in Older Individuals
- ClinicalTrials.gov ID
- NCT04907110
- Acronym / sponsor ID
- NL77756.068.21
- Conditions
- Overweight and Obesity, Aging, Type 2 Diabetes
- Keywords
- exercise, NR supplementation, NAD metabolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- 10 Aug 2021 (actual)
- Primary completion
- 2 Dec 2022 (actual)
- Study completion
- 7 Dec 2022 (actual)
- First posted
- 28 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The number of age-related chronic diseases (like obesity, type 2 diabetes and cardiovascular diseases) is increasing rapidly worldwide, reaching pandemic proportions. These age-related chronic diseases are associated with metabolic disturbances and mitochondrial dysfunction in humans. Nicotinamide adenosine dinucleotide (NAD) levels play an important role in energy metabolism and mitochondrial functioning and indeed it has been shown that high concentrations of NAD+ as well as a high NAD+/NADH ratio are strongly associated with metabolic and mitochondrial health. In contrast, decreased NAD+ bioavailability is reported in both ageing and obese humans as well as in diabetic mice. These findings fueled the idea of influencing NAD+ bioavailability in order to improve metabolic disturbances and mitochondrial dysfunction in humans. Supplementation with nicotinamide riboside (NR), a naturally occurring form of vitamin B3, may provide a way to boost cellular NAD+ levels. However, in contrast to animal studies, NR supplementation in humans has so far been unsuccessful in improving skeletal muscle mitochondrial function, exercise capacity or insulin sensitivity. Recently, it has been suggested that a situation where NAD+ levels become limited, is needed for NR supplementation to exert beneficial health effects. This situation could be achieved by combining exercise and NR supplementation. However, studies combining NR and exercise are lacking, which is why we would like to perform such a study here.
Detailed description
Rationale: The number of age-related chronic diseases (like obesity, type 2 diabetes and cardiovascular diseases) is increasing rapidly worldwide, reaching pandemic proportions. These age-related chronic diseases are associated with metabolic disturbances and mitochondrial dysfunction in humans. Nicotinamide adenosine dinucleotide (NAD) levels play an important role in energy metabolism and mitochondrial functioning and indeed it has been shown that high concentrations of NAD+ as well as a high NAD+/NADH ratio are strongly associated with metabolic and mitochondrial health. In contrast, decreased NAD+ bioavailability is reported in both ageing and obese humans as well as in diabetic mice. These findings fueled the idea of influencing NAD+ bioavailability in order to improve metabolic disturbances and mitochondrial dysfunction in humans. Supplementation with nicotinamide riboside (NR), a naturally occurring form of vitamin B3, may provide a way to boost cellular NAD+ levels. However, in contrast to animal studies, NR supplementation in humans has so far been unsuccessful in improving skeletal muscle mitochondrial function, exercise capacity or insulin sensitivity. Recently, it has been suggested that a situation where NAD+ levels become limited, is needed for NR supplementation to exert beneficial health effects. This situation could be achieved by combining exercise and NR supplementation. However, studies combining NR and exercise are lacking, which is why we would like to perform such a study here.
Objective: The primary objective of this study is to determine whether combined treatment of exercise and NR imposes greater improvements in skeletal muscle mitochondrial metabolism in older humans compared to exercise treatment alone. The secondary objective is to determine whether combined treatment of exercise and NR supplementation imposes greater improvements in sleeping metabolic rate (SMR). As explorative objectives, we will examine whether combined treatment with exercise and NR imposes greater improvements in muscle (NAD) metabolites, energy metabolism and physical performance.
Study design: The present study is a randomized, double-blinded, placebo-controlled double arm longitudinal intervention study in a pre and post design.
Study population: 30 older male and (postmenopausal) female participants, aged 65 - 80 years with a BMI between 25-35 kg/m2 will perform this study (15 participants in the exercise+placebo group, 15 participants in the exercise+NR group). From experience with similar studies, we estimate a drop-out rate of 20% and a screening failure of 50% (due to the strict inclusion criteria), resulting in maximally 36 subjects that have to be included and 72 subjects that have to be screened (maximally).
Intervention (if applicable): Participants will be asked to take two pills of NR (250mg/pill), or placebo, twice daily (two with breakfast and two with diner, a total of 4 pills/day; 1000mg/day), for 40 days. During days 17-38 of the NR intervention, participants will perform a 3-weeks supervised exercise training program with four ~30 min exercise sessions per week (two endurance session on a bike at 70%Wmax and two high intensity interval (HIIT) sessions. Participants will be randomly assigned to the placebo + exercise or NR + exercise arm. To assess the outcomes, participants will undergo three test days before the start of the NR supplementation and repeat these three test days at the end (day 38-40) of NR supplementation.
Main study parameters/endpoints: The primary study endpoints is ex vivo skeletal muscle mitochondrial function measured via high-resolution respirometry. Explorative objectives are muscle (NAD) metabolites, energy metabolism and physical performance.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- The present study is a randomized, double-blinded, placebo-controlled double arm longitudinal intervention study in a pre and post design.
| Arm | Type | Receives |
|---|---|---|
| Exercise + NR | Experimental | Dietary Supplement: Niagen, Other: ExerciseParticipants will be asked to take two pills of NR (250mg/pill) twice daily (a total of 4 pills/day; 1000mg/day), for 40 days. During days 17-38 of the NR intervention, participants will perform a 3-weeks supervised exercise training program with four ~30 min exercise sessions per week (two endurance session on a bike at 70%Wmax and two high intensity interval (HIIT) sessions. To assess the outcomes, participants will undergo three test days before the start of the NR supplementation and repeat these three test days at the end (day 38-40) of NR supplementation. |
| Exercise + Placebo | Placebo comparator | Other: ExerciseParticipants will be asked to take two pills of placebo, twice daily (a total of 4 pills/day), for 40 days. During days 17-38 of the intervention, participants will perform a 3-weeks supervised exercise training program with four ~30 min exercise sessions per week (two endurance session on a bike at 70%Wmax and two high intensity interval (HIIT) sessions. To assess the outcomes, participants will undergo three test days before the start of the NR supplementation and repeat these three test days at the end (day 38-40) of the placebo supplementation. |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Participants are able to provide signed and dated written informed consent prior to any study specific procedures
- Aged ≥ 65 and ≤ 80 years
- Body mass index (BMI) 25 - 35 kg/m2
- Stable dietary habits (no weight loss or gain > 5 kg in the past 3 months)
- No signs of active cardiovascular disease, liver or kidney malfunction
Key exclusion criteria (12 listed)
- Type 2 diabetes
- Patients with congestive heart failure and and/or severe renal and or liver insufficiency
- Uncontrolled hypertension
- Any contra-indication for MRI scanning
- Alcohol consumption of >3 servings per day for man and >2 servings per day for woman
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NiagenAlso: Nicotinamide Riboside (NR)Participants in the NR supplementation + exercise group will undergo oral NR supplementation for 40 days. NiagenTM is the name for the dietary supplement containing NR (ChromaDex, Inc. Irvine, USA). The total dosage of NR per day will be 1000mg. This supplementation time of 40 days 1000mg/day | Dietary supplement | Exercise + NR |
| ExerciseDuring days 17-38 of the NR/placebo intake, participants will perform a 3-weeks supervised exercise training program with four ~30 min exercise sessions per week (two endurance session on a bike at 70%Wmax and two high intensity interval (HIIT) sessions. | Other | Exercise + NR, Exercise + Placebo |
Primary outcome
Ex vivo muscle mitochondrial function
Time frame: Pre-intervention test day 3 + day 40 of the intervention NR/Placebo + exercise
Ex vivo mitochondrial function in skeletal muscle measured by oxygen consumption in muscle fibres (muscle biopsy vastus lateralis) on lipid-derived and carbohydrate-derived substrates.
12 secondary outcomes
Maximal aerobic capacity
Time frame: Pre-intervention test day 1 + Day 38
Physical performance
Time frame: Pre-intervention test day 1 + Day 38
Skeletal muscle NAD concentrations (ex-vivo)
Time frame: Pre-intervention test day 3 + Day 40
Skeletal muscle NAD concentration (in-vivo)
Time frame: Pre-intervention test day 3 + Day 40
Intrahepatic lipid content
Time frame: Pre-intervention test day 1 + Day 38
Upper leg muscle mass
Time frame: Pre-intervention test day 1 + Day 38
Body composition
Time frame: Pre-intervention test day 1 + Day 38
Quality of life
Time frame: Pre-intervention test day 1 + Day 38
Blood metabolites
Time frame: Pre-intervention test day 3 + Day 40
Submaximal exercise energy expenditure
Time frame: Pre-intervention test day 3 + Day 40
Sleeping metabolic rate
Time frame: Pre-intervention test day 2 + Day 39
Exercise efficiency
Time frame: Pre-intervention test day 3 + Day 40
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2023.
- Individual participant dataSharing planned: No. Data can be obtained with the principal investigator if desired.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Niagen and Exercise in people with Overweight and Obesity and Aging, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ex vivo muscle mitochondrial function (time frame: Pre-intervention test day 3 + day 40 of the intervention NR/Placebo + exercise). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2023.