Supplementation With Sirtuin Activators in Women With Increased Body Weight

NCT ID: NCT07245979

Last Updated: 2025-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-08

Study Completion Date

2027-03-01

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity & Overweight

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Experimental: sirtuin activators

Sirtuin activators supplementation for 6 months, daily dose of 1278 mg, taken twice a day in a capsulated form. One capsule 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.

Group Type EXPERIMENTAL

Sirtuin activators

Intervention Type DIETARY_SUPPLEMENT

Sirtuin acitivators supplementation for 6 months

Placebo comparator: placebo

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo supplementation for 6 months

Interventions

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Sirtuin activators

Sirtuin acitivators supplementation for 6 months

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo supplementation for 6 months

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Poznan University of Medical Sciences

OTHER

Sponsor Role collaborator

Nutropharma sp. z o.o.

UNKNOWN

Sponsor Role collaborator

Poznan University of Life Sciences

OTHER

Sponsor Role lead

Responsible Party

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Agata Chmurzyńska

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Agata Chmurzynska, Professor

Role: PRINCIPAL_INVESTIGATOR

Poznan Univeristy of Life Sciences

Locations

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Poznan University of Life Sciences

Poznan, , Poland

Site Status RECRUITING

Countries

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Poland

Central Contacts

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Agata Chmurzynska, Professor

Role: CONTACT

+486184661

Facility Contacts

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Agata Chmurzynska, Professor

Role: primary

+486184661

Other Identifiers

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Sirt activators

Identifier Type: -

Identifier Source: org_study_id

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