A randomized, double-blind placebo-controlled clinical study to evaluate the effect of LN22198 and LN22199 supplementation on blood NAD levels in healthy aging subjects.
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 105
- 试验地点
- 3
- 主要终点
- Change from baseline to the end of the study
研究概览
简要总结
The purpose of this study is to evaluate the effect of LN22198 and LN22199 supplementation on blood NAD levels in healthy aging subjects. A total of 105 male and female subjects of age between 55 and 70 years will be included in the study. Assessment of inclusion and exclusion criteria will be done based on clinical and laboratory investigations. The eligible subjects will be randomized as per the computer-generated randomization list. The subjects will be assigned to either LN22198 or LN22199 or placebo at 1:1:1 ratio. The participants will be instructed to take two capsules 500 mg each(1000mg/day) in the morning after breakfast for 60 days. The outcome measures include blood cellular Nicotinamide adenine dinucleotide (NAD+) levels, NAD Metabolites in blood (cellular NAAD and NMN), 1-MNA (1-MeNAM), Methionine, Me-2-Py and Homocysteine in urine, CD38 activity in isolated peripheral blood mononuclear cell (PBMC), GDF-15, NFL, TNF- Alpha and IL-6 in serum, Six-minute walk test, Quality of life questionnaire (SF-36), Mini-Mental State Examination, Newcastle mitochondrial quality of life measure (NMQ). Besides, the study will also record the vital signs and adverse events to evaluate the herbal composition’s safety and tolerability. The safety assessment of LN22198 and LN22199 will also include routine laboratory investigations on blood, urine, and clinical chemistry at screening and the final visit of the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 55.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Ambulatory, male and female subjects of age between 55 and 70 years with a Body Mass Index (BMI) of 24 to 29.9 kg/m
- •Subjects considered as healthy by principal investigator through medical history and laboratory results during screening.
- •Subjects ready to avoid taking vitamin B3 (Niacin, Nicotinic acid or niacinamide) or multivitamins two weeks prior to randomization and for the entire duration of the study period.
- •Subjects agree not to change their normal daily routine and diet.
- •Subjects agree to refrain from caffeine consumption on days when study visits included blood collection for metabolite measurement.
- •Subjects ready to discontinue the use of supplementations including herbal extracts that may affect the study outcome.
- •Subjects voluntarily agree to participate, sign written informed consent and comply with study protocol.
排除标准
- •Subjects underwent treatment for COVID-19 within last 3 months or tested positive during the study will be excluded.
- •Expectation of any surgery during the study period.
- •Subjects with fasting glucose levels (>126 mg/dL) and blood pressure (Systolic > 140 mmHg and Diastolic >90 mmHg).
- •Subjects with history of renal or liver impairment, any endocrine, inflammatory, cardiovascular, gastro-intestinal, neurological, psychiatric, neoplastic or metabolic disease.
- •Subjects suffering from COPD or having history of any respiratory or breathing disorders.
- •Subjects with HIV Positive status.
- •Alcohol intake >2 standard drinks per day or use of recreational drugs (such as cocaine, methamphetamine, marijuana, etc.) and smokers.
- •Subjects with history of pellagra or niacin deficiency.
- •Participation in any other trials involving investigational or marketed products within 30 days prior to the screening visit.
- •Clinically significant or abnormal laboratory results during screening.
- •Allergies to any of the study ingredient in the investigational products.
- •Any other condition that, in the opinion of the investigator, would adversely affect the subjects ability to complete the study or its measures or which may pose significant risk to the participant.
结局指标
主要结局
Change from baseline to the end of the study
时间窗: Day 1, Day 30 and Day 60
Blood cellular Nicotinamide adenine dinucleotide (NAD+) levels
时间窗: Day 1, Day 30 and Day 60
period in:
时间窗: Day 1, Day 30 and Day 60
次要结局
- Change from baseline to the end of the study(period in: Newcastle mitochondrial quality of life measure (NMQ))