- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04239898
Microgreen Consumption for Healthy Aging
August 13, 2020 updated by: Colorado State University
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
26
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Colorado
-
Fort Collins, Colorado, United States, 80523-1571
- Department of Food Science and Human Nutrition, Colorado State University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
45 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male or postmenopausal
- Aged 45-70
Exclusion Criteria:
- 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
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Red cabbage microgreens
2 cups of fresh red cabbage microgreens per day
|
2 cups per day
|
|
Experimental: Red beet microgreens
2 cups of fresh red beet microgreens per day
|
2 cups per day
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of participants retained
Time Frame: Baseline to 6 weeks
|
The number of participants retained versus lost to follow-up throughout the entire study
|
Baseline to 6 weeks
|
|
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
|
Baseline to 2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Gastrointestinal symptom self-assessment
Time Frame: Baseline to 2 weeks
|
Determine the effects on gastrointestinal symptoms using a validated questionnaire for each 2-week microgreen intervention
|
Baseline to 2 weeks
|
|
Gastrointestinal health
Time Frame: Baseline to 2 weeks
|
Determine the effects on gastrointestinal health using a daily bowel movement log for each 2-week microgreen intervention
|
Baseline to 2 weeks
|
|
Blood pressure
Time Frame: Baseline to 2 weeks
|
Determine the effects on brachial and aortic blood pressure measured by SphygmoCor for each 2-week microgreen intervention
|
Baseline to 2 weeks
|
|
Augmentation index
Time Frame: Baseline to 2 weeks
|
Determine the effects on augmentation index measured by SphygmoCor for each 2-week microgreen intervention
|
Baseline to 2 weeks
|
|
Microbiota modulation
Time Frame: Baseline to 2 weeks
|
Use of 16s rRNA sequencing of stool samples to determine the effects of each 2-week microgreen intervention on microbial populations
|
Baseline to 2 weeks
|
|
Changes in plasma metabolites
Time Frame: Baseline to 2 weeks
|
Use of mass spectrometry to determine the effects on plasma metabolites of bioactive compounds for each 2-week microgreen intervention
|
Baseline to 2 weeks
|
|
Acceptability
Time Frame: 6-week visit
|
Determine acceptability and feasibility of daily microgreen consumption through qualitative interviews with study participants at completion of the 6-week study
|
6-week visit
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 16, 2019
Primary Completion (Actual)
November 22, 2019
Study Completion (Actual)
November 30, 2019
Study Registration Dates
First Submitted
November 12, 2019
First Submitted That Met QC Criteria
January 21, 2020
First Posted (Actual)
January 27, 2020
Study Record Updates
Last Update Posted (Actual)
August 14, 2020
Last Update Submitted That Met QC Criteria
August 13, 2020
Last Verified
September 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- MG2019
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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