Greens-Based Crossover Trial to Improve Epigenetic Aging in Adults

N/AActive Not RecruitingNCT06537232

Auburn University20 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Aging

Interventions

Greens-based SupplementDIETARY_SUPPLEMENT

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

Eligibility

Sex: ALLMin age: 50 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Auburn University

Auburn, Alabama, United States

Outcomes

Primary Outcomes

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.

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

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.