AgingNCT04239898
Microgreen Consumption for Healthy Aging
A study testing Red cabbage microgreens and Red beet microgreens in people with Aging and Menopause, run by Colorado State University at 1 site in United States.
Trial summary
Microgreens are an emerging horticultural food crop with potential to improve human health. Previous research suggests they have broad consumer acceptance and that the micronutrient and bioactive compound levels are higher than that of their mature counterparts. Read more about this study
- Who is it for?
- Ages 45 to 70 yearsHealthy volunteers can take part
- What is being tested?
- Red cabbage microgreens and Red beet microgreens
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jul 2019to 30 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 45 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or postmenopausal
- Aged 45-70
Who cannot join
- Cardiovascular disease, hypertension, diabetes, neuropathy, thrombosis, cancer, gastrointestinal, kidney, liver, lung, or pancreatic disease
- Taking medication for high cholesterol, triglycerides, or blood sugar, or are taking testosterone medications
- Blood pressure ≥ 130/80 mm Hg, triglyceride levels > 200 mg/dL, low-density lipoprotein cholesterol levels ≥ 160 mg/dL, total cholesterol levels ≥ 240 mg/dL, and/or hemoglobin A1c ≥ 6.5%
- Weight change ≥ 3 kg (6.6 lb.) in the past 3 months prior to starting the study, are actively trying to lose weight, or are unwilling to remain weight stable throughout the study
- Have a BMI less than 18.5 or greater than 30 kg/m2
- Are not willing to maintain normal eating/drinking and exercise habits over the duration of the study
Show all 10Show fewer
- Currently smoke cigarettes or have a history of smoking cigarettes in the past 12 months
- Taking antibiotics or have taken them within one month of starting the study
- Binge and/or heavy drinker (>4 drinks on any given occasion and/or >14 drinks/week for men)
- Have allergies or contraindication to study foods, procedures, or procedure supplies
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Food Science and Human Nutrition, Colorado State University
Fort Collins, Colorado, 80523-1571
About this study
Official title: Feasibility, Acceptability, Tolerability, and Potential Health Effects of Microgreen Consumption in Healthy Middle-Aged and Older Adults
Microgreens are an emerging horticultural food crop with potential to improve human health. Previous research suggests they have broad consumer acceptance and that the micronutrient and bioactive compound levels are higher than that of their mature counterparts. To date, no studies have explored the feasibility of microgreen consumption, gastrointestinal tolerance of microgreen consumption, or their potential health impacts in humans. Therefore, the overall goal of this study is to explore the feasibility and acceptability of daily microgreen consumption, gastrointestinal tolerability, and potential health impacts of red cabbage and red beet microgreens in healthy middle-aged/older men and postmenopausal women - a population inherently at risk for chronic disease, e.g. cardiovascular disease.
- Being tested
- Red cabbage microgreens, Red beet microgreens
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Red cabbage microgreensOther
2 cups per day
Red beet microgreensOther
2 cups per day
| Study group | Role | What they receive |
|---|---|---|
| Red cabbage microgreens | Experimental | 2 cups of fresh red cabbage microgreens per day Receives: Other: Red cabbage microgreens |
| Red beet microgreens | Experimental | 2 cups of fresh red beet microgreens per day Receives: Other: Red beet microgreens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants retained
The number of participants retained versus lost to follow-up throughout the entire study
Measured: Baseline to 6 weeks
Adherence to the intervention
Adherence will be determined for each 2-week microgreen intervention through a daily microgreen consumption log
Measured: Baseline to 2 weeks
Secondary outcomes (6)
Gastrointestinal symptom self-assessment
Determine the effects on gastrointestinal symptoms using a validated questionnaire for each 2-week microgreen intervention
Measured: Baseline to 2 weeks
Gastrointestinal health
Determine the effects on gastrointestinal health using a daily bowel movement log for each 2-week microgreen intervention
Measured: Baseline to 2 weeks
Blood pressure
Determine the effects on brachial and aortic blood pressure measured by SphygmoCor for each 2-week microgreen intervention
Measured: Baseline to 2 weeks
Augmentation index
Determine the effects on augmentation index measured by SphygmoCor for each 2-week microgreen intervention
Measured: Baseline to 2 weeks
Microbiota modulation
Use of 16s rRNA sequencing of stool samples to determine the effects of each 2-week microgreen intervention on microbial populations
Measured: Baseline to 2 weeks
Acceptability
Determine acceptability and feasibility of daily microgreen consumption through qualitative interviews with study participants at completion of the 2-week study
Measured: 2-week visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start16 Jul 2019
- Primary completion22 Nov 2019
- Study completion30 Nov 2019
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colorado State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04239898
- Sponsor's protocol ID
- MG2019
- Status last verified
- Sep 2024
- First submitted
- 12 Nov 2019
- Last updated
- 19 Sep 2024
- 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 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility, Acceptability, Tolerability, and Potential Health Effects of Microgreen Consumption in Healthy Middle-Aged and Older Adults
- ClinicalTrials.gov ID
- NCT04239898
- Acronym / sponsor ID
- MG2019
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Colorado State UniversityUniversity, hospital or other
- Study start
- 16 Jul 2019 (actual)
- Primary completion
- 22 Nov 2019 (actual)
- Study completion
- 30 Nov 2019 (actual)
- First posted
- 27 Jan 2020 (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.
Microgreens are an emerging horticultural food crop with potential to improve human health. Previous research suggests they have broad consumer acceptance and that the micronutrient and bioactive compound levels are higher than that of their mature counterparts. To date, no studies have explored the feasibility of microgreen consumption, gastrointestinal tolerance of microgreen consumption, or their potential health impacts in humans. Therefore, the overall goal of this study is to explore the feasibility and acceptability of daily microgreen consumption, gastrointestinal tolerability, and potential health impacts of red cabbage and red beet microgreens in healthy middle-aged/older men and postmenopausal women - a population inherently at risk for chronic disease, e.g. cardiovascular disease.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Red cabbage microgreens | Experimental | Other: Red cabbage microgreens2 cups of fresh red cabbage microgreens per day |
| Red beet microgreens | Experimental | Other: Red beet microgreens2 cups of fresh red beet microgreens per day |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or postmenopausal
- Aged 45-70
Key exclusion criteria (10 listed)
- Cardiovascular disease, hypertension, diabetes, neuropathy, thrombosis, cancer, gastrointestinal, kidney, liver, lung, or pancreatic disease
- Taking medication for high cholesterol, triglycerides, or blood sugar, or are taking testosterone medications
- Blood pressure ≥ 130/80 mm Hg, triglyceride levels > 200 mg/dL, low-density lipoprotein cholesterol levels ≥ 160 mg/dL, total cholesterol levels ≥ 240 mg/dL, and/or hemoglobin A1c ≥ 6.5%
- Weight change ≥ 3 kg (6.6 lb.) in the past 3 months prior to starting the study, are actively trying to lose weight, or are unwilling to remain weight stable throughout the study
- Have a BMI less than 18.5 or greater than 30 kg/m2
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 |
|---|---|---|
| Red cabbage microgreens2 cups per day | Other | Red cabbage microgreens |
| Red beet microgreens2 cups per day | Other | Red beet microgreens |
Primary outcome
Number of participants retained
Time frame: Baseline to 6 weeks
The number of participants retained versus lost to follow-up throughout the entire study
Adherence to the intervention
Time frame: Baseline to 2 weeks
Adherence will be determined for each 2-week microgreen intervention through a daily microgreen consumption log
6 secondary outcomes
Gastrointestinal symptom self-assessment
Time frame: Baseline to 2 weeks
Gastrointestinal health
Time frame: Baseline to 2 weeks
Blood pressure
Time frame: Baseline to 2 weeks
Augmentation index
Time frame: Baseline to 2 weeks
Microbiota modulation
Time frame: Baseline to 2 weeks
Acceptability
Time frame: 2-week visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Red cabbage microgreens and Red beet microgreens in people with Aging and Menopause, run by Colorado State 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 2 inclusion and 10 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: finished, as of the sponsor's last update on 19 Sep 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of participants retained (time frame: Baseline to 6 weeks). The study lists 2 primary outcomes in all. 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 19 Sep 2024.