Supplementation With Sirtuin Activators in Women With Increased Body Weight

Poznan University of Life Sciences

Status: Enrolling

Conditions: Obesity & Overweight

Treatments: Dietary Supplement: Sirtuin activators; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT07245979

Sirt activators

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: Female

Ages: 40 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 participants in 2 patient groups, including a placebo group

Experimental: sirtuin activators

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Sirtuin activators

Placebo comparator: placebo

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: Placebo