AgingNCT06537232
Greens-Based Crossover Trial to Improve Epigenetic Aging in Adults
A study testing Greens-based Supplement in people with Aging, run by Auburn University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Greens-based Supplement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Sep 2024to Mar 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Crossover-Controlled Trial Investigating the Epigenetic Impact of a Greens-Based Supplement in Adults
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.
Read the 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
- Being tested
- Greens-based Supplement
- Keywords
- Epigenetic aging, Microbiome, Quality of Life, Overweight and Obesity
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Greens-based SupplementDietary supplement
Participant will consume one serving of greens-based supplement per day in the morning, for 30 days.
| Study group | Role | What they receive |
|---|---|---|
| Delayed supplementation | Experimental | Participants will consume greens-based supplement for 30 days after living their normal lives (free-living) for 30 days. Receives: 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. Receives: Dietary Supplement: Greens-based Supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from day 0 (baseline) to day 30 post intervention supplementation.
Secondary outcomes (12)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from Day 0 (baseline), Day 30 (Crossover/Midpoint ), and Day 60 (end of study)
Total body fat percentage
Change in total body fat as a percentage of total fat mass as measured by bioelectrical impedance (BIA). Lower values are optimal.
Measured: Change from Day 0 (baseline), Day 30 (Crossover/Midpoint ), and Day 60 (end of study)
Stool microbiome composition
16S changes in microbiome alpha diversity.
Measured: Change from Day 0 (baseline), Day 30 (Crossover/Midpoint ), and Day 60 (end of study)
Breath Hydrogen (ppm)
Breath hydrogen will be measured via QuinTron BreathTracker SC Analyzer every 30 minutes to 1.5 hours on days 21 and 51. Lower levels are optimal.
Measured: Change from Day 0 (baseline), Day 30 (Crossover/Midpoint ), and Day 60 (end of study)
Breath Methane (ppm)
Breath methane will be measured via QuinTron BreathTracker SC Analyzer every 30minutes to 1.5 hours on days 21 and 51. Lower levels are optimal.
Measured: Change from Day 0 (baseline), Day 30 (Crossover/Midpoint ), and Day 60 (end of study)
Physical Quality of Life
The SF-12 PCS (Short Form-12, Physical Component Score) is a health-related quality of life measure that assesses general physical functioning and well-being. SF-12 PCS scores range from 0-100 with higher scores indicating better general physical health.
Measured: Change from Baseline (day 0), Crossover/Midpoint (day 30), and End of study (day 60)
Sleep and Physical Activity- accelerometry
Average minutes of total daily sleep and physical activity measured via garmin watch.
Measured: Change from Baseline (day 0), Crossover/Midpoint (day 30), and End of study (day 60)
Total caloric intake
Three 24-hour dietary recalls will be obtained and entered into the and analyzed in the Nutrition Data System for Research (NDSR).
Measured: Change from Baseline (day 0), Crossover/Midpoint (day 30), and End of study (day 60)
Mental Quality of Life
The SF-12 MCS (Short Form-12, Mental Component Score) is a health-related quality of life measure that assesses general mental health status. SF-12 MCS scores range from 0-100 with higher scores indicating better general mental health.
Measured: Change from Baseline (day 0), Crossover/Midpoint (day 30), and End of study (day 60)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2024
- Study start4 Sep 2024
- Primary completion18 Dec 2024
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized crossover trial
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Auburn University
- Sponsor type
- University, hospital or other
- Collaborators
- Brickhouse Nutrition
- Responsible party
- Principal investigator, Andrew Fruge, Auburn University
- Investigators
- MIchael D Roberts, PhD, Principal investigator, Auburn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06537232
- Sponsor's protocol ID
- AUBHG 24
- Status last verified
- Jan 2025
- First submitted
- 31 Jul 2024
- Last updated
- 8 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Crossover-Controlled Trial Investigating the Epigenetic Impact of a Greens-Based Supplement in Adults
- ClinicalTrials.gov ID
- NCT06537232
- Acronym / sponsor ID
- AUBHG 24
- Conditions
- Aging
- Keywords
- Epigenetic aging, Microbiome, Quality of Life, Overweight and Obesity
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Auburn UniversityUniversity, hospital or other
- Collaborators
- Brickhouse Nutrition
- Study start
- 4 Sep 2024 (actual)
- Primary completion
- 18 Dec 2024 (actual)
- Study completion
- Mar 2025 (estimated)
- First posted
- 5 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized crossover trial
| Arm | Type | Receives |
|---|---|---|
| Delayed supplementation | Experimental | Dietary Supplement: Greens-based SupplementParticipants will consume greens-based supplement for 30 days after living their normal lives (free-living) for 30 days. |
| Immediate supplementation | Experimental | Dietary Supplement: Greens-based SupplementParticipant will consume greens-based supplement for 30 days after which they will crossover into a free-living/non-supplementation setting for 30 days. |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Greens-based SupplementParticipant will consume one serving of greens-based supplement per day in the morning, for 30 days. | Dietary supplement | Delayed supplementation, Immediate supplementation |
Primary outcome
Changes in DNA Methylation in Peripheral Blood Mononuclear Cells
Time frame: Change from day 0 (baseline) to day 30 post intervention supplementation.
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.
12 secondary outcomes
Fasting serum triglycerides
Time frame: Change from day 0 (baseline) to day 30 post intervention supplementation.
Fasting serum low-density lipoproteins (LDL)
Time frame: Change from day 0 (baseline) to day 30 post intervention supplementation.
Fasting serum blood glucose
Time frame: Change from day 0 (baseline) to day 30 post intervention supplementation.
Visceral fat percentage
Time frame: Change from Day 0 (baseline), Day 30 (Crossover/Midpoint ), and Day 60 (end of study)
Total body fat percentage
Time frame: Change from Day 0 (baseline), Day 30 (Crossover/Midpoint ), and Day 60 (end of study)
Stool microbiome composition
Time frame: Change from Day 0 (baseline), Day 30 (Crossover/Midpoint ), and Day 60 (end of study)
Breath Hydrogen (ppm)
Time frame: Change from Day 0 (baseline), Day 30 (Crossover/Midpoint ), and Day 60 (end of study)
Breath Methane (ppm)
Time frame: Change from Day 0 (baseline), Day 30 (Crossover/Midpoint ), and Day 60 (end of study)
Physical Quality of Life
Time frame: Change from Baseline (day 0), Crossover/Midpoint (day 30), and End of study (day 60)
Sleep and Physical Activity- accelerometry
Time frame: Change from Baseline (day 0), Crossover/Midpoint (day 30), and End of study (day 60)
Total caloric intake
Time frame: Change from Baseline (day 0), Crossover/Midpoint (day 30), and End of study (day 60)
Mental Quality of Life
Time frame: Change from Baseline (day 0), Crossover/Midpoint (day 30), and End of study (day 60)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MIchael D Roberts, PhD principal investigator
Auburn University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Greens-based Supplement in people with Aging, run by Auburn University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in DNA Methylation in Peripheral Blood Mononuclear Cells (time frame: Change from day 0 (baseline) to day 30 post intervention supplementation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2025.