Obesity & Overweight
Conditions
Brief summary
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_SUPPLEMENTSirtuin activators
Sirtuin acitivators supplementation for 6 months
DIETARY_SUPPLEMENTPlacebo
Placebo supplementation for 6 months
Sponsors
Poznan University of Life Sciences
Poznan University of Medical Sciences
NutroPharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Concentrations of blood lipids | 6 months, two measurements: at month 0 and 6 | Total cholesterol, Triacyglycerols, low density lipoprotein (LDL) cholesterol, high density lipoprotein (HDL) cholesteroll |
| Blood glucose concentrations | 6 months, two measurements: at month 0 and 6 | Blood glucose concentration |
| Ageing biomarkers: transcription level of the p16INK4a gene in peripheral blood mononuclear cells | 6 months, two measurements: at month 0 and 6 | transcription level of the p16INK4a gene in peripheral blood mononuclear cells |
| Ageing biomarkers: telomere lenght | 6 months, two measurements: at month 0 and 6 | telomere lenght measured in DNA isolated from whole blood |
| Ageing biomarkers: SA beta galactosidase activity | 6 months, two measurements: at month 0 and 6 | SA beta galactosidase activity |
| Oxidative stress | 6 months, two measurements: at month 0 and 6 | activities of oxidative stress enzymes in blood |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body mass | 6 months, two measurements: at month 0, 3 and 6 | Measured in kg |
| Body composition | 6 months, two measurements: at month 0, 3 and 6 | Body composition will include percent body fat and lean body mass measured with air displacement plethysmography |
| Waist and hips circumference | 6 months, two measurements: at month 0, 3 and 6 | Measured in cm |
| Genotype analyisis of the Sirt1 gene | baseline | Nucleotite variants at certain genomic position will be analysed |
Countries
Poland
Contacts
CONTACTAgata Chmurzynska, Professor
PRINCIPAL_INVESTIGATORAgata Chmurzynska, Professor
Poznan Univeristy of Life Sciences
Outcome results
None listed