Clinical trial NCT06537232: Greens-Based Crossover Trial to Improve Epigenetic Aging in Adults
Official title: A Randomized Crossover-Controlled Trial Investigating the Epigenetic Impact of a Greens-Based Supplement in Adults
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Aging
Keywords: Epigenetic aging
Microbiome
Quality of Life
Overweight and Obesity
Lead sponsor: Auburn University
Sponsor class: OTHER
Collaborators: name: Brickhouse Nutrition
First posted: 2024-08-05
Enrollment: 20
Sex: ALL
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized crossover trial
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Changes in DNA Methylation in Peripheral Blood Mononuclear Cells
timeFrame: Change from day 0 (baseline) to day 30 post intervention supplementation.
Secondary outcomes:
measure: Fasting serum triglycerides
timeFrame: Change from day 0 (baseline) to day 30 post intervention supplementation.
measure: Fasting serum low-density lipoproteins (LDL)
timeFrame: Change from day 0 (baseline) to day 30 post intervention supplementation.
measure: Fasting serum blood glucose
timeFrame: Change from day 0 (baseline) to day 30 post intervention supplementation.
measure: Visceral fat percentage
timeFrame: Change from Day 0 (baseline), Day 30 (Crossover/Midpoint ), and Day 60 (end of study)
measure: Total body fat percentage
timeFrame: Change from Day 0 (baseline), Day 30 (Crossover/Midpoint ), and Day 60 (end of study)
measure: Stool microbiome composition
timeFrame: Change from Day 0 (baseline), Day 30 (Crossover/Midpoint ), and Day 60 (end of study)
measure: Breath Hydrogen (ppm)
timeFrame: Change from Day 0 (baseline), Day 30 (Crossover/Midpoint ), and Day 60 (end of study)
measure: Breath Methane (ppm)
timeFrame: Change from Day 0 (baseline), Day 30 (Crossover/Midpoint ), and Day 60 (end of study)
measure: Physical Quality of Life
timeFrame: Change from Baseline (day 0), Crossover/Midpoint (day 30), and End of study (day 60)
measure: Sleep and Physical Activity- accelerometry
timeFrame: Change from Baseline (day 0), Crossover/Midpoint (day 30), and End of study (day 60)
measure: Total caloric intake
timeFrame: Change from Baseline (day 0), Crossover/Midpoint (day 30), and End of study (day 60)
measure: Mental Quality of Life
timeFrame: Change from Baseline (day 0), Crossover/Midpoint (day 30), and End of study (day 60)
Other outcomes:
Locations:
city: Auburn
country: United States
facility: Auburn University
state: Alabama
Study officials:
affiliation: Auburn University
name: MIchael D Roberts, PhD
role: PRINCIPAL_INVESTIGATOR
References: