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<p>Advanced glycation end products (AGEs) drive metabolic dysfunction, inflammation, and age-related disease, and their accumulation accelerates after menopause. Preclinical studies show that GLYLO, a five-compound glycation-lowering formulation (alpha-lipoic acid, nicotinamide, pyridoxine, benfotiamine, and piperine), reduces AGE burden and improves metabolic health, but its translational relevance in humans is unknown. The Glycation Reduction and Aging: a Clinical Evaluation (GRACE) trial is a randomized, double-blind, placebo-controlled pilot study testing whether six months of GLYLO supplementation lowers circulating AGEs and methylglyoxal (MGO) in postmenopausal women (45–65 years) with elevated adiposity (BMI ≥ 25 kg/m² or waist circumference ≥88 cm) and elevated HbA1c (5.5–6.4%). Secondary and exploratory endpoints include HOMA-IR, body composition, and reproductive hormones, cognitive and physical function, retinal aging, and systemic inflammation. GRACE is designed to address a critical gap in geroscience by evaluating whether targeting glycation can mitigate early metabolic and functional decline in postmenopausal women. ClinicalTrials.gov identifier <a href="https://clinicaltrials.gov/study/NCT06813261?cond=Postmenopause&amp;intr=GLYLO&amp;rank=1">NCT06813261</a>.</p>

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Reduction of glycation stress as a geroscience intervention: protocol for a pilot RCT in postmenopausal women

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年4月23日

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  • Vineeta Tanwar,
  • Pankaj Kapahi,
  • John C. Newman,
  • Brianna Stubbs

摘要

Advanced glycation end products (AGEs) drive metabolic dysfunction, inflammation, and age-related disease, and their accumulation accelerates after menopause. Preclinical studies show that GLYLO, a five-compound glycation-lowering formulation (alpha-lipoic acid, nicotinamide, pyridoxine, benfotiamine, and piperine), reduces AGE burden and improves metabolic health, but its translational relevance in humans is unknown. The Glycation Reduction and Aging: a Clinical Evaluation (GRACE) trial is a randomized, double-blind, placebo-controlled pilot study testing whether six months of GLYLO supplementation lowers circulating AGEs and methylglyoxal (MGO) in postmenopausal women (45–65 years) with elevated adiposity (BMI ≥ 25 kg/m² or waist circumference ≥88 cm) and elevated HbA1c (5.5–6.4%). Secondary and exploratory endpoints include HOMA-IR, body composition, and reproductive hormones, cognitive and physical function, retinal aging, and systemic inflammation. GRACE is designed to address a critical gap in geroscience by evaluating whether targeting glycation can mitigate early metabolic and functional decline in postmenopausal women. ClinicalTrials.gov identifier NCT06813261.