Food Supplement for Longevity

N/AActive Not RecruitingNCT07659834

Sam Treadway18 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Eligibility

Sex: ALLMin age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. 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. 2. Participant has no significant medical diagnosis (health individuals) 3. Participant takes no regular prescription medication 4. Participant is not undertaking any restrictive diet (e.g. Carnivore, Low FODMAP) 5. Participant agrees to adhere to guidance on fortified food intake for the duration of the study 6. Participant is a male or non-pregnant female and is ≥35 years of age 7. 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). 8. Participant can communicate well with the Investigator and to comply with the requirements for the entire study. 9. Participant has a body mass index (BMI) of 18.5 - 39.9kg/m2 (bounds included). Exclusion Criteria: 1. 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 2. Diagnosis of any current medical condition that requires regular prescription medication or at the discretion of the investigator may affect study endpoints 3. Participated in a trial of an investigational medical product or medical device in the last 28 days. 4. Females who report to be pregnant or lactating 5. Unwilling to maintain a stable diet for the duration of the trial. 6. Unwilling to consume \<5 portions per week fortified food per week 7. History of drug or alcohol abuse 8. Alcohol use \>2 standard servings/day 9. 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 10. Hypersensitivity to any component of the supplement 11. Previously identified niacin deficiency 12. Participant is involved in this study as an Investigator, sub-Investigator, study coordinator or other delegated study team members.

Outcomes

Primary Outcomes

Change in whole blood nicotinamide adenine dinucleotide (NAD+)

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.

Time frame: 30 days

Secondary Outcomes

Change in plasma NAD+ metabolites

Changes in plasma NAD+ metabolites. These include changes in Nicotinamide (NAM) and 1-Methylnicotinamide. These are both measures in milligrams (mg) using Liquid chromatography mass spectrometry. Changes to be measured from baseline to end of study.

Time frame: 30 days

Change in total coenzyme Q10 (CoQ10)

Changes in plasma coenzyme Q10. This is measured in micrograms (ug) using colourimetry. Changes to be measured from baseline to end of study.

Time frame: 30 days

Change in standard haematology and biochemistry blood panels

Changes in haematology and biochemistry blood panels. Changes till be assessed by a study doctor and assigned any clinical significance. Any clinical significant findings will be recorded as an adverse event. Changes will be measured from baseline to end of study.

Time frame: 30 days

Food Supplement for Longevity

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes