Sirtuin Activators and Weight Loss

NCT07802548 | Completed

• 1 other identifier: SIRTWAY
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Obesity is a chronic, multifactorial disease associated with a high burden of metabolic, cardiovascular, and psychosocial complications. Despite extensive research, the long-term effectiveness of lifestyle-based weight-management strategies remains limited, and there is a growing interest in molecular pathways that may enhance metabolic flexibility and improve treatment outcomes. Among these pathways, the sirtuin (SIRT) family-particularly SIRT1 and SIRT3-has emerged as a promising target due to its involvement in mitochondrial biogenesis, energy expenditure, oxidative metabolism, and the regulation of insulin sensitivity. Bioactive compounds that activate sirtuins, including nicotinamide riboside (NR), nicotinamide mononucleotide (NMN), resveratrol, and selected polyphenols, have shown metabolic benefits in preclinical models; however, high-quality human trials remain scarce and inconsistent. This project aims to investigate the efficacy of a standardized sirtuin-activator supplement on body-weight reduction, metabolic health, and energy-balance regulation in adults with overweight and obesity. The trial will be a randomized, double-blind, placebo-controlled intervention lasting 24 days. Participants will be assigned to either the sirtuin-activator group or placebo, with both groups receiving standardized dietary plan to ensure consistent caloric intake. The primary outcome will be absolute and relative weight loss, while secondary outcomes will include changes in waist circumference, body-composition parameters, resting metabolic rate, glycemic markers, lipid profiles and physical functioning. A key novelty of this project lies in testing a multi-ingredient formulation designed to synergistically enhance sirtuin signaling, addressing limitations observed in studies using single-compound approaches. By integrating nutritional guidance, rigorous clinical monitoring, and advanced biomarker profiling, this research aims to generate high-quality evidence on whether sirtuin activators can meaningfully augment weight-loss interventions in humans.

Conditions

Obesity & Overweight

Keywords

sirtuin; curcumin; resveratrol; leucin; EGCG; quercetin; niacin

Outcome Measures

Primary Outcomes (1)

• Body weight

  Body weight changes due to the intervention in kilograms measured with BodPod attached scale (Cosmed, Italy)

  Change from day 0 to day 25 and follow up (3-4 months)

Secondary Outcomes (7)

• Body composition

  day 0 and day 25 and follow up (3-4 months)

• Circumferences

  Day 0 and day 25

• Blood pressure

  day 0 and day 25

• Physical capacity

  day 0 and day 25

• Lipid profile (total cholesterol, LDL-cholesterol, HDL-cholesterol, triacylglycerides)

  day 0 and day 25

Study Arms (2)

SIRTUIN

EXPERIMENTAL

Weight loss diet + sirtuin activator supplementation

Dietary Supplement: SIRTUIN activators + weight loss diet

PLACEBO

PLACEBO COMPARATOR

Weight loss diet + placebo supplementation

Dietary Supplement: Placebo supplementation + weight loss diet

Interventions

SIRTUIN activators + weight loss diet DIETARY_SUPPLEMENT

Sirtuin activators: EGCG, resveratrol, quercetin, niacin, curcuminoids with weight loss diet

SIRTUIN

Placebo supplementation + weight loss diet DIETARY_SUPPLEMENT

Identical placebo with weight loss diet

PLACEBO

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BMI: 25-35 kg/m2
• stable body weight (change less than 10% in the last 3 months)
• age: 18-65 years
• both sexes

You may not qualify if:

• age \<18 or \>65 years
• BMI \<25 or \>35 kg/m2
• body weight change more than 10% in the last 3 months
• GLP-1RA treatment
• bariatric surgery in the past
• hypertension≥160/100 mmHg
• unstable heart disease
• pregnancy and breastfeeding
• insulin treatment or unstable diabetes
• Active and unstable liver, kidney, thyroid, gastroenterological diseases
• the use of curcuminoids, resveratrol, quercetin, EGCG supplements 3 months prior to study

Sponsors & Collaborators

• Poznan University of Life Sciences: lead

Study Sites (1)

Poznan University of Life Sciences

Poznan, Wielkopolska, 60-637, Poland

Location

MeSH Terms

Conditions

Obesity; Overweight

Interventions

Diet, Reducing

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

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

Study Record Dates

• First Submitted: June 10, 2026
• First Posted: September 3, 2026
• Study Start: January 19, 2026
• Primary Completion: July 30, 2026
• Study Completion: July 30, 2026
• Last Updated: September 3, 2026

Record last verified: 2026-09

Locations

PL (1)