Supplementation With Sirtuin Activators in Women With Increased Body Weight

NCT07245979 | Recruiting

• 1 other identifier: Sirt activators
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity & Overweight

Outcome Measures

Primary Outcomes (6)

• 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

Secondary Outcomes (4)

• Body mass

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

• Body composition

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

• Waist and hips circumference

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

• Genotype analyisis of the Sirt1 gene

  baseline

Study Arms (2)

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 g, leucin - 467 mg, Epigallocatechin gallate - 100 mg, quercetin - 100 mg, curcuminoids - 100 mg, niacin 10.7 g. Daily number of capsules will be 2 x 2 = 4.

Dietary Supplement: Sirtuin activators

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.

Dietary Supplement: Placebo

Interventions

Placebo DIETARY_SUPPLEMENT

Placebo supplementation for 6 months

Placebo comparator: placebo

Sirtuin activators DIETARY_SUPPLEMENT

Sirtuin acitivators supplementation for 6 months

Experimental: sirtuin activators

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• females
• age: 40-65 years
• overweight or obese: BMI \>25 kg/m2

You may not qualify if:

• 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

Sponsors & Collaborators

• Poznan University of Life Sciences: lead
• Nutropharma sp. z o.o.: collaborator
• Poznan University of Medical Sciences: collaborator

Study Sites (1)

Poznan University of Life Sciences

Poznan, Poland

RECRUITING

MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Agata Chmurzynska, Professor

  Poznan Univeristy of Life Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Agata Chmurzynska, Professor

CONTACT

+486184661; agata.chmurzynska@up.poznan.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 2, 2025
• First Posted: November 24, 2025
• Study Start: October 8, 2025
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)