Greens-Based Crossover Trial to Improve Epigenetic Aging in Adults

A Randomized Crossover-Controlled Trial Investigating the Epigenetic Impact of a Greens-Based Supplement in Adults

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Aging
• Intervention / Treatment: Dietary supplement: Greens-based Supplement

Detailed Description

Investigators will recruit 20 overweight/obese but otherwise healthy participants aged 50-65. Participants will be randomized to consume the greens-based supplement each morning for the first 30 days or second 30 days of the study. Usual diet, physical activity, and sleep patterns will be encouraged and monitored during the duration of the study.

Phlebotomy will be conducted at baseline, 30-day crossover, and 60-day follow-up to assess DNA methylation in peripheral blood mononuclear cells. Visceral and total body fat, stool microbiome composition, and actigraphy will also be assessed.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Auburn, Alabama, United States, 36849
      • Auburn University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Men and women of any ethnicity (women must be postmenopausal)
• Body Mass Index > 30 kg/m^2
• Low habitual dark green leafy vegetable consumption
• Willing to adhere to study protocol and measures
• Willing to communicate via smartphone technology
• Able to read, write and speak English

Exclusion Criteria:

• Overt cardiometabolic diseases such heart attack, stroke, diabetes, insulin resistance and non-alcoholic fatty liver disease, etc.
• Diagnosis of a transient ischemic attack in the 6 months prior to screening
• Diagnosis of cancer within 5 years prior to screening, except for cutaneous basal cell or squamous cell cancer resolved by excision
• Food allergies

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Delayed supplementation; Participants will consume greens-based supplement for 30 days after living their normal lives (free-living) for 30 days.	Dietary supplement: Greens-based Supplement; Participant will consume one serving of greens-based supplement per day in the morning, for 30 days.
Experimental: Immediate supplementation; Participant will consume greens-based supplement for 30 days after which they will crossover into a free-living/non-supplementation setting for 30 days.	Dietary supplement: Greens-based Supplement; Participant will consume one serving of greens-based supplement per day in the morning, for 30 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes 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

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)
Mental Quality of Life	The 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 mental health.	Change from Baseline (day 0), Crossover/Midpoint (day 30), and End of study (day 60)

Collaborators and Investigators

• Sponsor: Auburn University
• Collaborators: Brickhouse Nutrition
• Investigators: Principal Investigator: MIchael D Roberts, PhD, Auburn University

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2024
• Primary Completion (Actual): December 18, 2024
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: July 31, 2024
• First Submitted That Met QC Criteria: July 31, 2024
• First Posted (Actual): August 5, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 7, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Microbiome; Quality of Life; Overweight and Obesity; Epigenetic aging
• Other Study ID Numbers: AUBHG 24

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No