An Open Label Study to Assess the Effect of a Food Supplement on Markers of Cellular Ageing and Longevity
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Change in whole blood nicotinamide adenine dinucleotide (NAD+)
研究概览
简要总结
As we age, the cells in our body gradually lose their ability to produce energy efficiently and repair damage. This process, known as cellular ageing, is linked to lower levels of a molecule called Nicotinamide Adenine Dinucleotide (NAD⁺), which is essential for energy production and maintaining healthy cell function. Other factors, such as reduced antioxidant capacity and mitochondrial decline, also contribute to ageing.
This study will explore whether a daily food supplement, taken for one month, can improve markers of cellular health in adults aged 35 and over. Thrive⁺ contains ingredients that may support energy metabolism and antioxidant defences, including compounds that boost NAD⁺ levels and Coenzyme Q10 (CoQ10), which helps cells produce energy. It also includes resveratrol, a plant compound thought to promote healthy ageing.
The research will take place at The Functional Gut Clinic in Manchester and will involve 15 healthy volunteers. Participants will attend two clinic visits: one at the start and one after 30 days of supplementation. At each visit, they will have blood tests, blood pressure and heart rhythm checks, a simple grip strength test, and complete short questionnaires on mood and wellbeing. Women of childbearing potential will also have a pregnancy test. The supplement will be taken as one capsule per day for 30 days.
The main question is whether the supplement increases NAD⁺ levels in the blood. We will also look at other markers, such as antioxidant status, inflammation, and physical measures like grip strength. The study aims to provide insight into whether supplementation can support healthy ageing in everyday life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participant has provided written informed consent before participating in the study after being given a full description of the study and prior to any study-specific procedures being performed.
- •Participant has no significant medical diagnosis (health individuals)
- •Participant takes no regular prescription medication
- •Participant is not undertaking any restrictive diet (e.g. Carnivore, Low FODMAP)
- •Participant agrees to adhere to guidance on fortified food intake for the duration of the study
- •Participant is a male or non-pregnant female and is ≥35 years of age
- •If WOCBP participant is willing to adhere to one of the following methods of contraception i) Hormonal contraception e.g. the 'pill' or an implant ii) Intrauterine device (IUD) iii) Intrauterine hormone-releasing system (IUS) iv) Hysterectomy v) Vasectomised partner vi) Sexual abstinence (if it is in line with your preferred and usual lifestyle).
- •Participant can communicate well with the Investigator and to comply with the requirements for the entire study.
- •Participant has a body mass index (BMI) of 18.5 - 39.9kg/m2 (bounds included).
排除标准
- •Participant has consumed nutritional supplement, that in the opinion of the investigator may affect any of the study primary or secondary endpoints, in the past 3 months
- •Diagnosis of any current medical condition that requires regular prescription medication or at the discretion of the investigator may affect study endpoints
- •Participated in a trial of an investigational medical product or medical device in the last 28 days.
- •Females who report to be pregnant or lactating
- •Unwilling to maintain a stable diet for the duration of the trial.
- •Unwilling to consume <5 portions per week fortified food per week
- •History of drug or alcohol abuse
- •Alcohol use >2 standard servings/day
- •Being in the opinion of the investigator unsuitable, in the circumstance where patient safety of scientific value of the study may be affected i.e. unable to swallow capsules, phobia to needles, significant travel that would affect adhereance study participation etc
- •Hypersensitivity to any component of the supplement
- •Previously identified niacin deficiency
- •Participant is involved in this study as an Investigator, sub-Investigator, study coordinator or other delegated study team members.
研究组 & 干预措施
Longevity supplement
This is a single arm study, with the a participants receiving the active supplement. Supplement containing Niagen NR 300mg, Trans resveratrol 250mg, Niacin (B3) 120mg, CoEnzyme Q10 100mg and Copper 0.3mg. Taken once daily.
干预措施: Longevity supplement (Dietary Supplement)
结局指标
主要结局
Change in whole blood nicotinamide adenine dinucleotide (NAD+)
时间窗: 30 days
Change in whole blood NAD+ measured using Liquid chromatography mass spectrometry. Changes measured from baseline (pre supplement) to end of study (30 days of supplementation). measured in micrograms per millilitre.
次要结局
- Change in plasma NAD+ metabolites(30 days)
- Change in total coenzyme Q10 (CoQ10)(30 days)
- Change in standard haematology and biochemistry blood panels(30 days)
研究者
Sam Treadway
Principal Clinical Scientist
The Functional Gut Clinic