AgingNADSNCT03310034
NAD Supplementation Study
A study testing NAD-precursors in people with Aging and Mitochondrial Function, run by Maastricht University at 1 site in Netherlands.
Trial summary
This research project aims to determine whether supplementing with a mixture of the NAD+-precursors NA, NAM, and tryptophan can stimulate skeletal muscle mitochondrial function in physically compromised, elderly humans. Read more about this study
- Who is it for?
- Ages 65 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging, Mitochondrial Function
- What is being tested?
- NAD-precursors
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Nov 2017to 6 Mar 2020
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Males and females
- Age ≥ 65 ≤ 75 years;
- BMI ≥ 20 kg/m2 ≤ 30 kg/m2;
- Normal physical activity levels: maximum of 1 hour per week engagement in a structured exercise session;
- SPPB score 4-9 and (pre-)frail;
- Subject should be in sufficient health to participate in the experiments, to be judged by the responsible physician based on the subject's medical history.
Who cannot join
- Not meeting all inclusion criteria;
- Smoking;
- Excessive alcohol use and/or drug abuse;
- Subjects with diabetes mellitus type 2;
- Significant food allergies or intolerances concerning the study products;
- Participation in another biomedical study within 1 month before the first study visit, possibly interfering with the study results;
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- Medication use known to hamper subject's safety during the study procedures;
- Subjects who use selective serotonin re-uptake inhibitors (SSRI), or selective norepinephrin re-uptake inhibitors (SNRI), or monoamino oxidase inhibitors (MAO-inhibitors), or clomipramine, or St. John's wort (Hypericum perforatum);
- Subjects with contra-indications for MRI;
- Subjects who do not want to be informed about unexpected medical findings;
- Subjects who do not want that their treating physician to be informed;
- Co-morbidities to which the intervention or program the may pose as a complicating factor;
- Inability to participate and/or complete the required measurements.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of NAD+-Precursor Supplementation on Energy Metabolism in Physically Compromised Elderly
This research project aims to determine whether supplementing with a mixture of the NAD+-precursors NA, NAM, and tryptophan can stimulate skeletal muscle mitochondrial function in physically compromised, elderly humans. Outcomes are related to mitochondrial function, energy metabolism, and physical function will be investigated.
- Conditions
- Aging, Mitochondrial Function
- Being tested
- NAD-precursors, Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NAD-precursorsDietary supplement
Intervention product containing the NAD+-precursors nicotinic acid, nicotinamide, and tryptophan (total of 204 NE per serving) in a whey protein source for 31 days.
ControlDietary supplement
Control product containing amino-acid mixture resembling whey-protein not containing the NAD+-precursors nicotinic acid, nicotinamide, and tryptophan. To be taken for 31 days.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | Not described Receives: Dietary Supplement: NAD-precursors |
| Control | Placebo comparator | Not described Receives: Dietary Supplement: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ex vivo mitochondrial respiration
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: After 4 weeks of supplementation.
Basal metabolic rate
Basal metabolic rate expressed as kcal/kg/min
Measured: After 4 weeks of supplementation.
In vivo mitochondrial capacity
In vivo mitochondrial capacity measured with 31P-MRS.
Measured: After 4 weeks of supplementation.
Submaximal exercise energy expenditure
Submaximal exercise energy expenditure expressed as kcal/kg/min
Measured: After 4 weeks of supplementation.
Secondary outcomes (4)
Glucose tolerance
Glucose tolerance measured by oral glucose tolerance test.
Measured: After 4 weeks of supplementation.
Ectopic lipid accumulation
Liver and skeletal muscle lipid accumulation measured with H-MRS in vivo.
Measured: After 4 weeks of supplementation.
Acetylcarnitine levels
Skeletal muscle acetylcarnitine levels measured with H-MRS in vivo, before and after exercise stimulation (cycling).
Measured: After 4 weeks of supplementation.
Physical function
Measured by Short Physical Performance Battery and Frailty criteria.
Measured: After 4 weeks of supplementation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2017
- Study start1 Nov 2017
- Primary completion6 Mar 2020
- Study completion6 Mar 2020
Why it stopped: Concluded study following COVID19 outbreak and inability to complete study as designed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, dubbel-blind, cross-over trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patrick Schrauwen, Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03310034
- Sponsor's protocol ID
- NL61204.068.17
- Acronym
- NADS
- Status last verified
- Mar 2020
- First submitted
- 10 Oct 2017
- Last updated
- 20 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Connell NJ, Grevendonk L, Fealy CE, Moonen-Kornips E, Bruls YMH, Schrauwen-Hinderling VB, de Vogel J, Hageman R, Geurts J, Zapata-Perez R, Houtkooper RH, Havekes B, Hoeks J, Schrauwen P. NAD+-Precursor Supplementation With L-Tryptophan, Nicotinic Acid, and Nicotinamide Does Not Affect Mitochondrial Function or Skeletal Muscle Function in Physically Compromised Older Adults. J Nutr. 2021 Oct 1;151(10):2917-2931. doi: 10.1093/jn/nxab193.
PubMed 34191033
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of NAD+-Precursor Supplementation on Energy Metabolism in Physically Compromised Elderly
- ClinicalTrials.gov ID
- NCT03310034
- Acronym / sponsor ID
- NADS / NL61204.068.17
- Conditions
- Aging, Mitochondrial Function
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Concluded study following COVID19 outbreak and inability to complete study as designed.
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Maastricht UniversityUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 6 Mar 2020 (actual)
- Study completion
- 6 Mar 2020 (actual)
- First posted
- 16 Oct 2017 (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.
This research project aims to determine whether supplementing with a mixture of the NAD+-precursors NA, NAM, and tryptophan can stimulate skeletal muscle mitochondrial function in physically compromised, elderly humans. Outcomes are related to mitochondrial function, energy metabolism, and physical function will be investigated.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized, dubbel-blind, cross-over trial
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Dietary Supplement: NAD-precursors |
| Control | Placebo comparator | Dietary Supplement: Control |
Who may qualify
- Ages
- 65 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Males and females
- Age ≥ 65 ≤ 75 years;
- BMI ≥ 20 kg/m2 ≤ 30 kg/m2;
- Normal physical activity levels: maximum of 1 hour per week engagement in a structured exercise session;
- SPPB score 4-9 and (pre-)frail;
Key exclusion criteria (13 listed)
- Not meeting all inclusion criteria;
- Smoking;
- Excessive alcohol use and/or drug abuse;
- Subjects with diabetes mellitus type 2;
- Significant food allergies or intolerances concerning the study products;
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 |
|---|---|---|
| NAD-precursorsIntervention product containing the NAD+-precursors nicotinic acid, nicotinamide, and tryptophan (total of 204 NE per serving) in a whey protein source for 31 days. | Dietary supplement | Intervention |
| ControlControl product containing amino-acid mixture resembling whey-protein not containing the NAD+-precursors nicotinic acid, nicotinamide, and tryptophan. To be taken for 31 days. | Dietary supplement | Control |
Primary outcome
Ex vivo mitochondrial respiration
Time frame: After 4 weeks of supplementation.
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.
Basal metabolic rate
Time frame: After 4 weeks of supplementation.
Basal metabolic rate expressed as kcal/kg/min
In vivo mitochondrial capacity
Time frame: After 4 weeks of supplementation.
In vivo mitochondrial capacity measured with 31P-MRS.
Submaximal exercise energy expenditure
Time frame: After 4 weeks of supplementation.
Submaximal exercise energy expenditure expressed as kcal/kg/min
4 secondary outcomes
Glucose tolerance
Time frame: After 4 weeks of supplementation.
Ectopic lipid accumulation
Time frame: After 4 weeks of supplementation.
Acetylcarnitine levels
Time frame: After 4 weeks of supplementation.
Physical function
Time frame: After 4 weeks of supplementation.
Results and safety
The study was stopped early (reason given: Concluded study following COVID19 outbreak and inability to complete study as designed.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2020.
- Derived from this study: PubMed 34191033Connell NJ, Grevendonk L, Fealy CE, Moonen-Kornips E, Bruls YMH, Schrauwen-Hinderling VB, de Vogel J, Hageman R, Geurts J, Zapata-Perez R, Houtkooper RH, Havekes B, Hoeks J, Schrauwen P. NAD+-Precursor Supplementation With L-Tryptophan, Nicotinic Acid, and Nicotinamide Does Not Affect Mitochondrial Function or Skeletal Muscle Function in Physically Compromised Older Adults. J Nutr. 2021 Oct 1;151(10):2917-2931. doi: 10.1093/jn/nxab193.
- 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.
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 NAD-precursors in people with Aging and Mitochondrial Function, run by Maastricht University 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 6 inclusion and 13 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: stopped early, as of the sponsor's last update on 20 Aug 2020. 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 was stopped early (reason given: Concluded study following COVID19 outbreak and inability to complete study as designed.). Results are not available in the source record.
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 mitochondrial respiration (time frame: After 4 weeks of supplementation.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03310034, which also lists 1 linked publication.
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 20 Aug 2020.