Supplementation With Sirtuin Activators in Women With Increased Body Weight
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Sirtuin activators, Placebo.
- Who it may be relevant to
- Registry conditions: Obesity & Overweight. Basic parameters: 40 years — 65 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Poland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Assessment of the Effect of Sirtuin Activator Supplementation on Cellular, Metabolic and Anthropometric Parameters in Women
Overview
The goal of this clinical trial is to learn if the six-month supplementation with sirtuin activators can affect metabolism in 40-to-65-year old women with increased body weight. The main questions it aims to answer are: Does sirtuin activators affect lipid and carbohydrate metabolism? Does sirtuin activators affect oxydative stress, immune functions and cell ageing? Researchers will compare sirtuin activators to a placebo (a look-alike substance that contains no drug) to see if drug sirtuin activators works to improve metabolic status. Participants will: Take sirtuin activators or a placebo every day for 6 months. Visit the university once every 3 months for checkups and tests.
Interventions
- Dietary supplement Sirtuin activators
Sirtuin acitivators supplementation for 6 months - Dietary supplement Placebo
Placebo supplementation for 6 months
Primary outcome measures
- Concentrations of blood lipids [Time frame: 6 months, two measurements: at month 0 and 6]
- Blood glucose concentrations [Time frame: 6 months, two measurements: at month 0 and 6]
- Ageing biomarkers: transcription level of the p16INK4a gene in peripheral blood mononuclear cells [Time frame: 6 months, two measurements: at month 0 and 6]
- Ageing biomarkers: telomere lenght [Time frame: 6 months, two measurements: at month 0 and 6]
- Ageing biomarkers: SA beta galactosidase activity [Time frame: 6 months, two measurements: at month 0 and 6]
- Oxidative stress [Time frame: 6 months, two measurements: at month 0 and 6]
Secondary outcome measures (4)
- Body mass [Time frame: 6 months, two measurements: at month 0, 3 and 6]
- Body composition [Time frame: 6 months, two measurements: at month 0, 3 and 6]
- Waist and hips circumference [Time frame: 6 months, two measurements: at month 0, 3 and 6]
- Genotype analyisis of the Sirt1 gene [Time frame: baseline]
Eligibility criteria
Inclusion criteria
- females
- age: 40-65 years
- overweight or obese: BMI >25 kg/m2
Exclusion criteria
- males
- BMI < 25 kg/m2
- sirtuin activators administration for 3 months prior to study
- pregnancy or breastfeeding
- recent dieting or being on calorie restricted diet
- receiving pharmacotherapy to treat obesity, diabetes or hyperlipidemia
- post-bariatric surgery
- diabetes
- cancer
- chronic kidney, liver or autoimmune diseases
- alcohol addiction
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Other
Study locations
Poland · 1 center
- Poznan University of Life Sciences — Poznan
Identifiers
NCT: NCT07245979 · Sirt activators