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| Name | Class |
|---|---|
| Poznan University of Medical Sciences | OTHER |
| NutroPharma | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: sirtuin activators | Experimental | Sirtuin activators supplementation for 6 months, daily dose of 1278 mg, taken twice a day in a capsulated form. Daily dose will contain: resveratrol - 500 mg, leucin - 467 mg, Epigallocatechin gallate - 100 mg, quercetin - 100 mg, curcuminoids - 100 mg, niacin 10.7 mg. Daily number of capsules will be 2 x 2 = 4. |
|
| Placebo comparator: placebo | Placebo Comparator | Placebo will be an inactive substance (maltodextrin) provided in the same-looking capsules as sirtuin activators. Placebo will be administered twice a day, daily number of capsules will be 2 x 2 = 4. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sirtuin activators | Dietary Supplement | Sirtuin acitivators supplementation for 6 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Concentrations of blood lipids | Total cholesterol, Triacyglycerols, low density lipoprotein (LDL) cholesterol, high density lipoprotein (HDL) cholesteroll | 6 months, two measurements: at month 0 and 6 |
| Blood glucose concentrations | Blood glucose concentration | 6 months, two measurements: at month 0 and 6 |
| Ageing biomarkers: transcription level of the p16INK4a gene in peripheral blood mononuclear cells | transcription level of the p16INK4a gene in peripheral blood mononuclear cells | 6 months, two measurements: at month 0 and 6 |
| Ageing biomarkers: telomere lenght | telomere lenght measured in DNA isolated from whole blood | 6 months, two measurements: at month 0 and 6 |
| Ageing biomarkers: SA beta galactosidase activity | SA beta galactosidase activity | 6 months, two measurements: at month 0 and 6 |
| Oxidative stress | activities of oxidative stress enzymes in blood | 6 months, two measurements: at month 0 and 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Body mass | Measured in kg | 6 months, two measurements: at month 0, 3 and 6 |
| Body composition | Body composition will include percent body fat and lean body mass measured with air displacement plethysmography |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Agata Chmurzynska, Professor | Contact | +486184661 | agata.chmurzynska@up.poznan.pl |
| Name | Affiliation | Role |
|---|---|---|
| Agata Chmurzynska, Professor | Poznan Univeristy of Life Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Poznan University of Life Sciences | Recruiting | Poznan | Poland |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| Placebo | Dietary Supplement | Placebo supplementation for 6 months |
|
| 6 months, two measurements: at month 0, 3 and 6 |
| Waist and hips circumference | Measured in cm | 6 months, two measurements: at month 0, 3 and 6 |
| Genotype analyisis of the Sirt1 gene | Nucleotite variants at certain genomic position will be analysed | baseline |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |