Greens-Based Crossover Trial to Improve Epigenetic Aging in Adults

Auburn University

Status: Active, not recruiting

Conditions: Aging

Treatments: Dietary Supplement: Greens-based Supplement

Study type: Interventional

Funder types: Other

Identifiers

NCT06537232

AUBHG 24

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 50 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Delayed supplementation

Experimental group

Description:

Participants will consume greens-based supplement for 30 days after living their normal lives (free-living) for 30 days.

Treatment:

Dietary Supplement: Greens-based Supplement

Immediate supplementation

Experimental group

Description:

Participant will consume greens-based supplement for 30 days after which they will crossover into a free-living/non-supplementation setting for 30 days.

Treatment:

Dietary Supplement: Greens-based Supplement