The Effect of Sirtuin Supplementation During Weight Loss Diet on Body Mass and Composition and Physical Functions in Overweight and Obese Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Body weight
研究概览
简要总结
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.
详细描述
- Background and Rationale
Sirtuins (SIRT1-SIRT7) are a family of NAD⁺-dependent enzymes involved in metabolic regulation, mitochondrial biogenesis, oxidative stress response, and inflammation control. Evidence from model organisms demonstrates that sirtuin overexpression can extend lifespan. In mammals, caloric restriction enhances sirtuin synthesis, leading to improved mitochondrial function, reduced oxidative stress, and attenuated inflammation. Collectively, these mechanisms underpin the potential role of sirtuins in promoting metabolic health and preventing non-communicable diseases.
Numerous non-nutritive bioactive compounds naturally present in foods activate sirtuin pathways. The most extensively studied is resveratrol, found in grapes and red wine, which has been shown to stimulate SIRT1 and downstream metabolic pathways. Additional sirtuin activators include epigallocatechin gallate (EGCG) from green tea, curcuminoids from turmeric, and quercetin, present in apples, grapes, and onions. Despite their presence in commonly consumed foods, typical dietary intake is low, suggesting that targeted supplementation may be necessary to achieve meaningful physiological effects-particularly in populations at metabolic risk.
Overweight and obesity remain major public health challenges worldwide. Excess adiposity is strongly associated with chronic, low-grade inflammation and increased risk of cardiometabolic diseases. While caloric restriction remains a cornerstone of weight reduction, adjunct interventions may enhance metabolic adaptations to energy deficit. SIRT1, for example, has been shown to increase energy expenditure and shift substrate utilization toward enhanced fatty-acid oxidation. Thus, supplementation with sirtuin activators may support weight loss and metabolic improvements when combined with a hypocaloric diet. 2. Study Objective
The primary objective of this study is to evaluate the effects of supplementation with sirtuin activators (resveratrol, curcuminoids, EGCG, quercetin) combined with a short-term low-energy diet on:
- body weight and body composition,
- physical performance,
- blood pressure,
- biochemical and inflammatory markers in adults with overweight and obesity.
- Study Design
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI: 25-35 kg/m2
- •stable body weight (change less than 10% in the last 3 months)
- •age: 18-65 years
- •both sexes
排除标准
- •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
研究组 & 干预措施
SIRTUIN
Weight loss diet + sirtuin activator supplementation
干预措施: SIRTUIN activators + weight loss diet (Dietary Supplement)
PLACEBO
Weight loss diet + placebo supplementation
干预措施: Placebo supplementation + weight loss diet (Dietary Supplement)
结局指标
主要结局
Body weight
时间窗: Change from day 0 to day 25 and follow up (3-4 months)
Body weight changes due to the intervention in kilograms measured with BodPod attached scale (Cosmed, Italy)
次要结局
- 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)
- Fasting glucose concentration(Day 0 and 25)
- Liver enzymes(Day 0 and 25)