Greens-Based Crossover Trial to Improve Epigenetic Aging in Adults
NCT Number: NCT06537232
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Aging
Interventions: DIETARY_SUPPLEMENT: Greens-based Supplement
Sponsor: Auburn University
Collaborators: Brickhouse Nutrition
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-09-01
Completion Date: 2025-03
Locations: Auburn University, Auburn, Alabama, 36849, United States

Summary:
The primary purpose of this study is to assess changes in epigenetic markers of aging and physiological parameters in overweight older adults consuming a mixed greens-based supplement over a 30-day period in a randomized crossover design.

Primary Outcome Measures: Changs in DNA Methylation in Peripheral Blood Mononuclear Cells, Change from Baseline in Epigenetic Aging Profiles (i.e. DNA Methylation), after 30 day intervention. Participants will provide blood samples at their baseline study visit, which occurs before the start of the intervention, and at their visit at the end of the 30th of intervention supplementation., Change from day 0 (baseline) to day 30 post intervention supplementation.
Secondary Outcome Measures: Fasting serum triglycerides, Phlebotomy will be obtained while fasted 8+ hours and triglycerides will be measured as part of a comprehensive metabolic panel and reported in mg/dl. Lower concentrations are optimal., Change from day 0 (baseline) to day 30 post intervention supplementation.|Fasting serum low-density lipoproteins (LDL), Phlebotomy will be obtained while fasted 8+ hours and low-density lipoproteins (LDL) will be measured as part of a comprehensive metabolic panel and reported in mg/dl. Lower concentrations are optimal., Change from day 0 (baseline) to day 30 post intervention supplementation.|Fasting serum blood glucose, Phlebotomy will be obtained while fasted 8+ hours and blood glucose will be measured as part of a comprehensive metabolic panel and reported in mg/dl. Lower concentrations are optimal., Change from day 0 (baseline) to day 30 post intervention supplementation.|Visceral fat percentage, Change in visceral fat as a percentage of total fat mass as measured by bioelectrical impedance (BIA). Lower values are optimal., Change from Day 0 (baseline), Day 30 (Crossover/Midpoint ), and Day 60 (end of study)|Total body fat percentage, Change in total body fat as a percentage of total fat mass as measured by bioelectrical impedance (BIA). Lower values are optimal., Change from Day 0 (baseline), Day 30 (Crossover/Midpoint ), and Day 60 (end of study)|Stool microbiome composition, 16S changes in microbiome alpha diversity., Change from Day 0 (baseline), Day 30 (Crossover/Midpoint ), and Day 60 (end of study)|Breath Hydrogen (ppm), Breath hydrogen will be measured via QuinTron BreathTracker SC Analyzer every 30 minutes to 1.5 hours on days 21 and 51. Lower levels are optimal., Change from Day 0 (baseline), Day 30 (Crossover/Midpoint ), and Day 60 (end of study)|Breath Methane (ppm), Breath methane will be measured via QuinTron BreathTracker SC Analyzer every 30minutes to 1.5 hours on days 21 and 51. Lower levels are optimal., Change from Day 0 (baseline), Day 30 (Crossover/Midpoint ), and Day 60 (end of study)|Physical Quality of Life, The SF-12 PCS (Short Form-12, Physical Component Score) is a health-related quality of life measure that assesses general physical functioning and well-being. SF-12 PCS scores range from 0-100 with higher scores indicating better general physical health., Change from Baseline (day 0), Crossover/Midpoint (day 30), and End of study (day 60)|Mental Quality of Life, SF-12 MCSThe SF-12 MCS (Short Form-12, Mental Component Score) is a health-related quality of life measure that assesses general mental health status. SF-12 MCS scores range from 0-100 with higher scores indicating better general physical health., Change from Baseline (day 0), Crossover/Midpoint (day 30), and End of study (day 60)|Sleep and Physical Activity- accelerometry, Average minutes of total daily sleep and physical activity measured via garmin watch., Change from Baseline (day 0), Crossover/Midpoint (day 30), and End of study (day 60)|Total caloric intake, Three 24-hour dietary recalls will be obtained and entered into the and analyzed in the Nutrition Data System for Research (NDSR)., Change from Baseline (day 0), Crossover/Midpoint (day 30), and End of study (day 60)