Greens-Based Crossover Trial to Improve Epigenetic Aging in Adults

NCT ID: NCT06537232

Last Updated: 2025-01-08

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-04
• Study Completion Date: 2025-03-31

Brief 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.

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.

Conditions

Aging

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Delayed supplementation

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

Group Type: EXPERIMENTAL

Greens-based Supplement

Intervention Type: DIETARY_SUPPLEMENT

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

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.

Group Type: EXPERIMENTAL

Greens-based Supplement

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Greens-based Supplement

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Brickhouse Nutrition

UNKNOWN

Sponsor Role: collaborator

Auburn University

OTHER

Sponsor Role: lead

Responsible Party

Andrew Fruge

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

MIchael D Roberts, PhD

Role: PRINCIPAL_INVESTIGATOR

Auburn University

Locations

Auburn University

Auburn, Alabama, United States

Countries

United States

Other Identifiers

AUBHG 24

Identifier Type: -

Identifier Source: org_study_id