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Nicotinamide Riboside as an Enhancer of Exercise Therapy in Hypertensive Older Adults (The NEET Trial)
Plain-language guide to NCT04112043: phase 1 randomized trial of NAD+, 147 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT04112043
- Phase
- phase 1
- Status
- completed
- Start
- 2020-07-28
- Completion (planned or actual)
- 2023-05-26
- Participants
- 147 (actual)
- Design
- randomized, triple-blind, treatment
- Conditions studied
- Hypertension
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
This registered phase 1 trial tested NAD+.
Novel compound, nicotinamide riboside may enhance the effects of exercise therapy in hypertensive older adults.
It had three arms (groups): NR plus Walking Exercise (active comparator), Walking Exercise plus Placebo (active comparator) and NR Alone (active comparator).
The registry classes the interventions as behavioral and drug.
More on the Plan
An objective of this study, therefore, is to test a combination of aerobic exercise and nicotinamide riboside, a compound that replenishes NAD+ levels, to optimize exercise's SBP-lowering effect in hypertensive older adults.
All participants will undergo daytime continuous SBP at baseline, 3 weeks, and 6 weeks, and arterial-stiffness measurements by pulse-wave velocity at baseline and at 6 weeks.
Elevated SBP will be determined as daytime average equal to or above 130 mmHg, measured by the 24-hour blood-pressure device.
To their knowledge, this study will be the first attempt to enhance exercise therapy with nicotinamide riboside in hypertensive older adults.
Who Took Part
The registry lists 147 actual participants took part.
It was open to people of any sex aged from 55 years up to 105 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Age 55 years and older. Daytime average of systolic blood pressure of ≥ 130 mmHg and \< 160 mmHg. Sedentary lifestyle, defined as \< 150 min/wk of moderate physical activity as assessed by the CHAMPS questionnaire. Willingness to be randomized to either treatment group. Willingness to participate in all study procedures.
The full record lists 5 inclusion and 18 exclusion criteria; among the exclusions: failure to provide informed consent; daytime average of systolic blood pressure ≥160 mmhg; regular consumption of nicotinamide riboside supplement.
How the Study Was Run
The set-up was randomized, parallel-group and triple-blind.
Random assignment meant chance, not the researchers, decided who got NAD+ and who got the comparison, which limits bias.
The NAD+ group and the comparison group ran side by side rather than switching.
As a double-blind NAD+ study, the assignments were hidden from both participants and investigators until the end.
Those kept unaware of assignments: participant, investigator and outcomes assessor.
It started in 2020-07-28 with completion listed for 2023-05-26.
It ran at 1 site in United States.
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): Change in Daytime Systolic Blood Pressure (time frame: Baseline; Week 6).
It also tracked 1 secondary outcome, for example Change in Arterial Stiffness.
What This Means in Plain Language
Put simply, this is a phase 1, randomized trial of NAD+ in 147 people.
The trial is marked completed; results are posted on the registry, and this page does not restate them.
More context: the NAD+ compound page, all human trials.
Our Notes on the Compound
NAD+: The coenzyme that accepts electrons at complex I.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.