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Supplementation With Sirtuin Activators in Women With Increased Body Weight

ConditionObesity & Overweight
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age40-65
SponsorPoznan University of Life Sciences

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

females

age: 40-65 years

overweight or obese: BMI >25 kg/m2

Disqualifiers

males

BMI < 25 kg/m2

sirtuin activators administration for 3 months prior to study

pregnancy or breastfeeding

Trial design

Design model

Parallel

Treatments tested in this trial

  • Sirtuin activators

    Dietary supplement

    Sirtuin acitivators supplementation for 6 months

  • Placebo

    Dietary supplement

    Placebo supplementation for 6 months

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Experimental: sirtuin activatorsExperimental treatment 1 intervention
Group B: Placebo comparator: placeboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Concentrations of blood lipids

Total cholesterol, Triacyglycerols, low density lipoprotein (LDL) cholesterol, high density lipoprotein (HDL) cholesteroll

Time frame
6 months, two measurements: at month 0 and 6
2

Blood glucose concentrations

Blood glucose concentration

Time frame
6 months, two measurements: at month 0 and 6
3

Ageing biomarkers: transcription level of the p16INK4a gene in peripheral blood mononuclear cells

transcription level of the p16INK4a gene in peripheral blood mononuclear cells

Time frame
6 months, two measurements: at month 0 and 6
4

Ageing biomarkers: telomere lenght

telomere lenght measured in DNA isolated from whole blood

Time frame
6 months, two measurements: at month 0 and 6

Secondary outcomes

1

Body mass

Measured in kg

Time frame
6 months, two measurements: at month 0, 3 and 6
2

Body composition

Body composition will include percent body fat and lean body mass measured with air displacement plethysmography

Time frame
6 months, two measurements: at month 0, 3 and 6
3

Waist and hips circumference

Measured in cm

Time frame
6 months, two measurements: at month 0, 3 and 6
4

Genotype analyisis of the Sirt1 gene

Nucleotite variants at certain genomic position will be analysed

Time frame
baseline

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Poznan University of Life Sciences

Lead sponsor

Poznan University of Medical Sciences

Collaborator

NutroPharma

Collaborator

Source ClinicalTrials.gov
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