Effects of Ten-Week Oral Nicotinamide Riboside Supplementation With Aerobic Exercises on Blood Pressure in Post- Menopausal Women With Elevated/Stage I Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 112
- 主要终点
- Blood pressure
研究概览
简要总结
Hypertension continues to pose a significant global health challenge, with rates of optimal blood pressure control remaining low - particularly in China, where fewer than 5% of individuals with hypertension achieve guideline-recommended targets.
Age-associated endothelial dysfunction and arterial stiffness are recognized as the key contributors to the development of hypertension and the unique role of nicotinamide adenine dinucleotide (NAD) depletion in the pathogenesis of vascular dysfunction has been recently discovered. Treatment with nicotinamide riboside (NR), an NAD precursor, has shown promise in preliminary clinical trials for improving blood pressure and vascular health in at-risk populations.
In parallel, aerobic exercise is a well-established non-pharmacologic intervention known to improve cardiovascular outcomes. Emerging studies suggest that exercise may modulate NAD biosynthesis pathways, pointing toward a synergistic potential when combined with NAD-boosting strategies. However, clinical data evaluating the combined effects of NR supplementation and aerobic exercise remain scarce.
Our randomized, placebo-controlled, four-arm, parallel-group design seeks to address this gap. The investigators will investigate the independent and combined effects of 10-week NR supplementation and brisk walking on blood pressure and vascular health in post-menopausal women with elevated/stage I hypertension. This population is specifically targeted due to their heightened risk for vascular dysfunction post-menopause and the observed responsiveness to NR-based interventions in prior studies.
The investigators believe the findings from this trial will provide insight into the feasibility, safety, and efficacy of combining NAD-boosting supplementation with structured exercise in a uniquely vulnerable and previously understudied population. The potential to identify a low-risk, non-pharmaceutical therapeutic approach holds strong implications for public health, particularly in aging women with early-stage hypertension.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women absent of menstruation for over one year,
- •Chinese, and
- •fulfill the criteria of elevated/stage I hypertension according to 2025 American College of Cardiology/American Heart Association Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults (i.e., blood pressure ≥120/80 mmHg based on an average of ≥2 readings obtained on ≥2 occasions)
排除标准
- •presence of health conditions that contraindicate participation in exercise training, such as a history of cardiovascular disease, cancer, or musculoskeletal disorders,
- •a history of hysterectomy,
- •current use of vitamin B supplements and/or NAD precursors,
- •ongoing hormone replacement therapy within the past six months,
- •any changes in antihypertensive medication type or dosage within the last three months, or
- •engagement in regular physical activity, defined as at least 150 minutes of moderate-intensity exercise or 75 minutes of vigorous-intensity exercise per week, during the three months prior to enrollment.
研究组 & 干预措施
NR + BW
NR supplementation plus brisk walking
干预措施: Brisk walking (Behavioral)
NR + BW
NR supplementation plus brisk walking
干预措施: Nicotinamide Riboside 1000 mg (Dietary Supplement)
PL + BW
Placebo plus brisk walking
干预措施: Brisk walking (Behavioral)
PL + BW
Placebo plus brisk walking
干预措施: Placebo (Other)
NR
NR supplementation only
干预措施: Nicotinamide Riboside 1000 mg (Dietary Supplement)
PL
Placebo only
干预措施: Placebo (Other)
结局指标
主要结局
Blood pressure
时间窗: From enrollment to the end of follow-up at 20 weeks
Blood pressure will be measured using an automated sphygmomanometer that meets the standards from the Association for the Advancement of Medical Instrumentation and the European Society for Hypertension and following standardized procedures. Two measurements will be taken after 5 min sitting rest in a quiet room with comfortable temperature. During assessments, participants will be seated with their back supported, feet flat on the floor, legs uncrossed, and their arm resting on a table with the midpoint of the upper arm aligned at heart level. Two readings of systolic and diastolic blood pressures will be obtained, spaced 2 minutes apart, and the average of the two measurements will be recorded as the final blood pressure reading. If the difference between the two measurements exceeds 5 mmHg, an additional reading will be taken, and the average of all three readings will be used as the final measurement.
次要结局
- Whole Blood NAD concentration(From enrollment to the end of follow-up at 20 weeks)
- Endothelin 1(From enrollment to the end of follow-up at 20 weeks)
- Angiotensin(From enrollment to the end of follow-up at 20 weeks)
- Body mass(From enrollment to the end of follow-up at 20 weeks)
- Fat mass(From enrollment to the end of follow-up at 20 weeks)
- Fat-free mass(From enrollment to the end of follow-up at 20 weeks)
- Fat percentage(From enrollment to the end of follow-up at 20 weeks)
- Height(From enrollment to the end of follow-up at 20 weeks)
- BMI(From enrollment to the end of follow-up at 20 weeks)
- Waist Circumference(From enrollment to the end of follow-up at 20 weeks)
- Seven-day accelerometry(From enrollment to the end of follow-up at 20 weeks)
- 30-second chair stand test(From enrollment to the end of follow-up at 20 weeks)
- Handgrip strength(From enrollment to the end of follow-up at 20 weeks)
研究者
ZHANG Jiaqi
Principal Investigator
Chinese University of Hong Kong