NCT06537232

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 31, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 5, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

September 4, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 18, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

January 8, 2025

Status Verified

January 1, 2025

Enrollment Period

4 months

First QC Date

July 31, 2024

Last Update Submit

January 7, 2025

Conditions

Aging

Keywords

Epigenetic agingMicrobiomeQuality of LifeOverweight and Obesity

Outcome Measures

Primary Outcomes (1)

  • 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.

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

Secondary Outcomes (12)

  • Fasting serum triglycerides

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

  • Fasting serum low-density lipoproteins (LDL)

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

  • Fasting serum blood glucose

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

  • Visceral fat percentage

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

  • Total body fat percentage

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

  • +7 more secondary outcomes

Study Arms (2)

Delayed supplementation

EXPERIMENTAL

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

Dietary Supplement: Greens-based Supplement

Immediate supplementation

EXPERIMENTAL

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

Dietary Supplement: Greens-based Supplement

Interventions

Greens-based SupplementDIETARY_SUPPLEMENT

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

Delayed supplementationImmediate supplementation

Eligibility Criteria

Age50 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Auburn University

Auburn, Alabama, 36849, United States

Location

MeSH Terms

Conditions

OverweightObesity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • MIchael D Roberts, PhD

    Auburn University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: Randomized crossover trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 31, 2024

First Posted

August 5, 2024

Study Start

September 4, 2024

Primary Completion

December 18, 2024

Study Completion

March 1, 2025

Last Updated

January 8, 2025

Record last verified: 2025-01

Locations

US(1)