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Active, Not Recruiting

NCT Number: NCT06537232

Greens-Based Crossover Trial to Improve Epigenetic Aging 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Aging Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

50 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Auburn University

Auburn, Alabama, 36849, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Greens-based Supplement

Dietary Supplement

Participant will consume one serving of greens-based supplement per day in the morning, for 30 days.

Primary outcomes

  1. Changes in DNA Methylation in Peripheral Blood Mononuclear Cells

    Time frame: Change from day 0 (baseline) to day 30 post intervention supplementation.

    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.

Secondary outcomes

  1. Fasting serum triglycerides

    Time frame: Change from day 0 (baseline) to day 30 post intervention supplementation.

    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.

  2. Fasting serum low-density lipoproteins (LDL)

    Time frame: Change from day 0 (baseline) to day 30 post intervention supplementation.

    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.

  3. Fasting serum blood glucose

    Time frame: Change from day 0 (baseline) to day 30 post intervention supplementation.

    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.

  4. Visceral fat percentage

    Time frame: Change from Day 0 (baseline), Day 30 (Crossover/Midpoint ), and Day 60 (end of study)

    Change in visceral fat as a percentage of total fat mass as measured by bioelectrical impedance (BIA). Lower values are optimal.

  5. Total body fat percentage

    Time frame: Change from Day 0 (baseline), Day 30 (Crossover/Midpoint ), and Day 60 (end of study)

    Change in total body fat as a percentage of total fat mass as measured by bioelectrical impedance (BIA). Lower values are optimal.

  6. Stool microbiome composition

    Time frame: Change from Day 0 (baseline), Day 30 (Crossover/Midpoint ), and Day 60 (end of study)

    16S changes in microbiome alpha diversity.

  7. Breath Hydrogen (ppm)

    Time frame: Change from Day 0 (baseline), Day 30 (Crossover/Midpoint ), and Day 60 (end of study)

    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.

  8. Breath Methane (ppm)

    Time frame: Change from Day 0 (baseline), Day 30 (Crossover/Midpoint ), and Day 60 (end of study)

    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.

  9. Physical Quality of Life

    Time frame: Change from Baseline (day 0), Crossover/Midpoint (day 30), and End of study (day 60)

    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.

  10. Sleep and Physical Activity- accelerometry

    Time frame: Change from Baseline (day 0), Crossover/Midpoint (day 30), and End of study (day 60)

    Average minutes of total daily sleep and physical activity measured via garmin watch.

  11. Total caloric intake

    Time frame: Change from Baseline (day 0), Crossover/Midpoint (day 30), and End of study (day 60)

    Three 24-hour dietary recalls will be obtained and entered into the and analyzed in the Nutrition Data System for Research (NDSR).

  12. Mental Quality of Life

    Time frame: Change from Baseline (day 0), Crossover/Midpoint (day 30), and End of study (day 60)

    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.

Sponsors and collaborators

Lead sponsor

Auburn University

Other

Collaborators

  • Brickhouse Nutrition

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Aug 5, 2024
Registry last updated
Jan 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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