AgingPhase 2NADMetNCT02950441
Nicotinamide Adenine Dinucleotide and Skeletal Muscle Metabolic Phenotype
A Phase 2 study testing Nicotinamide Riboside in people with Aging, run by University of Birmingham at 1 site in United Kingdom.
Trial summary
This study is designed to assess the physiological consequences of elevating Nicotinamide Adenine Dinucleotide (NAD+) availability using Nicotinamide Riboside (NR) supplementation in skeletal muscle tissue, and examine its effect upon muscle metabolic phenotype. Read more about this study
- Who is it for?
- Ages 70 to 80 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Nicotinamide Riboside
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2016to Sep 2019
- Phase
- Phase 2
- 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 70 to 80 years
- Men only
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Male sex
- Age 70-80 years
- BMI 20-30kg/m2
- Participants who are able to discontinue aspirin for 3 days prior to the muscle biopsy
- Participants who are able to discontinue statins and vitamin D supplements for a week before the second visit and for the duration of the study
Who cannot join
- Serious active medical conditions including inflammatory diseases or malignancies
- Significant past medical history including diabetes mellitus, ischaemic heart disease, cerebrovascular disease, significant respiratory disease requiring medication, epilepsy
- High blood pressure (BP>160/100mmHg)
- Oral Anticoagulants (like Warfarin, Dabigatran, Rivaroxaban) or Clopidogrel therapy which will increase the risk of bruising following a muscle biopsy
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
University Hospitals Birmingham NHS Foundation Trust
Birmingham, West Midlands, B15 2TH
Yasir Elhassan, MRCP, +441214158705, y.mohamedelhassan@bham.ac.uk
About this study
Official title: Nicotinamide Adenine Dinucleotide and Skeletal Muscle Metabolic Phenotype (NADMet)
This study is designed to assess the physiological consequences of elevating Nicotinamide Adenine Dinucleotide (NAD+) availability using Nicotinamide Riboside (NR) supplementation in skeletal muscle tissue, and examine its effect upon muscle metabolic phenotype.
Read the detailed description
-NAD+ sensitive metabolic decline in ageing, including sarcopenia, leads to a reduction in energy metabolism, contribute to chronic inflammation, disposing individuals to metabolic disease and overall decreased later-life health. Prominent metabolic changes include a decline in NAD+ content and deterioration in muscle NAD+ mediated signalling and mitochondrial function, ultimately compromising skeletal muscle and whole body energy homeostasis.
The most efficient means to boost NAD+ in muscle appears to be oral delivery of NR, and participants will be supplemented with 1000mg NR (2x x250mg tablets twice daily) for 3 weeks.
- Hypothesis: elevating skeletal muscle NAD+ bioavailability using NR supplementation will increase markers of mitochondrial function and that will manifest as a more favourable metabolic profile.
- Study Setting: the study will be carried out at the NIHR/Wellcome Trust Clinical Research Facility, Queen Elizabeth Hospital Birmingham.
- Conditions
- Aging
- Being tested
- Nicotinamide Riboside, Placebo
- Keywords
- Nicotinamide Riboside, Nicotinamide Adenine Dinucleotide, Skeletal muscle, Metabolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotinamide RibosideDietary supplement
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Nicotinamide Riboside | Experimental | 1000mg (2x250mg tablets twice daily) Receives: Dietary Supplement: Nicotinamide Riboside |
| Placebo | Placebo comparator | Two tablets twice daily Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mitochondrial function assessment in skeletal muscle using high resolution respirometry
Mitochondrial function assessment on muscle biopsies using high resolution respirometry
Measured: Following 3 weeks of NR supplementation
Skeletal muscle NAD+ levels in vastus lateralis biopsy using targeted metabolomics
Measured: Following 3 weeks of NR supplementation
Secondary outcomes (7)
Improvement in response to oral glucose tolerance test/HOMA-IR
Measured: Following 3 weeks of NR supplementation
Improvement in lipid profile
Measured: Following 3 weeks of NR supplementation
Muscle Arterio-Venous Difference - Tissue-specific metabolite trafficking, oxygen consumption and CO2 production
Measured: Following 3 weeks of NR supplementation
Muscle biopsy: adaptive expression profile (genomic)
Measured: Following 3 weeks of NR supplementation
Changes in resting metabolic rate using indirect calorimetry
Measured: Following 3 weeks of NR supplementation
24 hour urine collection - NAD+ metabolomics and changes in steroid ratios using Gas chromatography/ mass spectrometry
Measured: Following 3 weeks of NR supplementation
Muscle strength - grip testing
Measured: Following 3 weeks of NR supplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2016 (estimated)
- Study startJun 2016
- Primary completionSep 2018 (estimated)
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gareth Lavery, PhD, Principal investigator, Institute of Metabolism and Systems Research, University of Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02950441
- Sponsor's protocol ID
- RG_15-152
- Acronym
- NADMet
- Status last verified
- Oct 2016
- First submitted
- 25 Oct 2016
- Last updated
- 7 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nicotinamide Adenine Dinucleotide and Skeletal Muscle Metabolic Phenotype (NADMet)
- ClinicalTrials.gov ID
- NCT02950441
- Acronym / sponsor ID
- NADMet / RG_15-152
- Conditions
- Aging
- Keywords
- Nicotinamide Riboside, Nicotinamide Adenine Dinucleotide, Skeletal muscle, Metabolism
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University of BirminghamUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 1 Nov 2016 (estimated)
- 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.
This study is designed to assess the physiological consequences of elevating Nicotinamide Adenine Dinucleotide (NAD+) availability using Nicotinamide Riboside (NR) supplementation in skeletal muscle tissue, and examine its effect upon muscle metabolic phenotype.
Detailed description
-NAD+ sensitive metabolic decline in ageing, including sarcopenia, leads to a reduction in energy metabolism, contribute to chronic inflammation, disposing individuals to metabolic disease and overall decreased later-life health. Prominent metabolic changes include a decline in NAD+ content and deterioration in muscle NAD+ mediated signalling and mitochondrial function, ultimately compromising skeletal muscle and whole body energy homeostasis.
The most efficient means to boost NAD+ in muscle appears to be oral delivery of NR, and participants will be supplemented with 1000mg NR (2x x250mg tablets twice daily) for 3 weeks.
- Hypothesis: elevating skeletal muscle NAD+ bioavailability using NR supplementation will increase markers of mitochondrial function and that will manifest as a more favourable metabolic profile.
- Study Setting: the study will be carried out at the NIHR/Wellcome Trust Clinical Research Facility, Queen Elizabeth Hospital Birmingham.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nicotinamide Riboside | Experimental | Dietary Supplement: Nicotinamide Riboside1000mg (2x250mg tablets twice daily) |
| Placebo | Placebo comparator | Other: PlaceboTwo tablets twice daily |
Who may qualify
- Ages
- 70 to 80 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Male sex
- Age 70-80 years
- BMI 20-30kg/m2
- Participants who are able to discontinue aspirin for 3 days prior to the muscle biopsy
- Participants who are able to discontinue statins and vitamin D supplements for a week before the second visit and for the duration of the study
Key exclusion criteria (4 listed)
- Serious active medical conditions including inflammatory diseases or malignancies
- Significant past medical history including diabetes mellitus, ischaemic heart disease, cerebrovascular disease, significant respiratory disease requiring medication, epilepsy
- High blood pressure (BP>160/100mmHg)
- Oral Anticoagulants (like Warfarin, Dabigatran, Rivaroxaban) or Clopidogrel therapy which will increase the risk of bruising following a muscle biopsy
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 |
|---|---|---|
| Nicotinamide Riboside | Dietary supplement | Nicotinamide Riboside |
| Placebo | Other | Placebo |
Primary outcome
Mitochondrial function assessment in skeletal muscle using high resolution respirometry
Time frame: Following 3 weeks of NR supplementation
Mitochondrial function assessment on muscle biopsies using high resolution respirometry
Skeletal muscle NAD+ levels in vastus lateralis biopsy using targeted metabolomics
Time frame: Following 3 weeks of NR supplementation
7 secondary outcomes
Improvement in response to oral glucose tolerance test/HOMA-IR
Time frame: Following 3 weeks of NR supplementation
Improvement in lipid profile
Time frame: Following 3 weeks of NR supplementation
Muscle Arterio-Venous Difference - Tissue-specific metabolite trafficking, oxygen consumption and CO2 production
Time frame: Following 3 weeks of NR supplementation
Muscle biopsy: adaptive expression profile (genomic)
Time frame: Following 3 weeks of NR supplementation
Changes in resting metabolic rate using indirect calorimetry
Time frame: Following 3 weeks of NR supplementation
24 hour urine collection - NAD+ metabolomics and changes in steroid ratios using Gas chromatography/ mass spectrometry
Time frame: Following 3 weeks of NR supplementation
Muscle strength - grip testing
Time frame: Following 3 weeks of NR supplementation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2017.
- Individual participant dataSharing planned: No
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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.
Gareth Lavery, PhD principal investigator
Institute of Metabolism and Systems Research, University of Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nicotinamide Riboside in people with Aging, run by University of Birmingham at 1 site in United Kingdom.
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 4 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: status not confirmed, as of the sponsor's last update on 7 Jun 2017. 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 United Kingdom. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yasir Elhassan, MRCP (+441214158705, y.mohamedelhassan@bham.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mitochondrial function assessment in skeletal muscle using high resolution respirometry (time frame: Following 3 weeks of NR supplementation). The study lists 2 primary outcomes in all. 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 7 Jun 2017.