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NCT ID: NCT06242535 Recruiting - Obesity Clinical Trials

Pilot Study of GLY-LOW Supplementation in Postmenopausal Women With Obesity

Start date: July 27, 2023
Phase: Early Phase 1
Study type: Interventional

A combination of generally regarded as safe (GRAS) compounds named GLY-LOW, which included: alpha lipoic acid, pyridoxamine, nicotinamide, piperine and thiamine, were examined in pre-clinical experiments. GLY-LOW supplementation reduced caloric intake and increased insulin sensitivity in mice. In female mice, GLY-LOW supplementation reversed aging-related declines in female hormones. Studies in humans are needed to examine the feasibility, utility and efficacy of GLY-LOW supplementation in post-menopausal women with obesity toward improving aging-related impairments. The effect of GLY-LOW supplementation on these obesity and biological age-related impairments in post-menopausal adult female humans with obesity is unknown. We aim to translate the findings of GLY-LOW supplementation in animals to a cohort of healthy, postmenopausal females at birth with obesity by conducting a one-group, no-placebo comparer, pre post intervention clinical trial. Additionally, we propose to examine the specific effect of supplementation by GLY-LOW on biological aging via retina scan. The objectives of the proposed pilot study are: I. Conduct a 6-month pilot study to examine the feasibility, utility and efficacy of GLY-LOW supplementation in a total of 40 postmenopausal female born adults > 55 years with obesity (> 30 BMI) Ia. Examine alterations in self-reported caloric intake and the following health and biological aging, parameters prior to and after 6 months of GLY-LOW supplementation: 1. Self-reported Caloric Intake 2. Metabolic disease risk 3. Cardiovascular disease risk 4. Metabolic assessments 5. Hormones 6. Physical Function and Fitness 7. Muscular strength 8. Cognitive Function and Depression assessments 9. Systemic inflammation 10. Biological aging 11. Safety parameters (also every 2 months during the intervention; ECG at baseline and 2 months only) 12, Compliance measures (pill counts and interviews every 2 months during the intervention)

NCT ID: NCT05437809 Recruiting - Obesity Clinical Trials

Biobehavioral Reward Responses Associated With Consumption of Nutritionally Diverse Ultra-Processed Foods

Start date: February 20, 2023
Phase: N/A
Study type: Interventional

The changing food environment, with increasingly abundant ultra-processed food (UPF) options, may directly contribute to rising rates of obesity, though it is unknown which ingredients in UPF elevate their reinforcing nature in a way that may lead to overconsumption. The proposed study is the first to systematically examine differences in the rewarding characteristics of and physiological and metabolic responses to UPFs that are high in fat, refined carbohydrates (like sugar), or both. Understanding the biobehavioral underpinnings that enhance the reinforcing potential of ingredients in UPF (e.g., fat vs. refined carbohydrates) can inform novel intervention targets for the treatment of overeating and obesity.