ClinicalTrials.gg
CompletedNCT04239898Updated Sep 19, 2024

Microgreen Consumption for Healthy Aging

An interventional study of Red cabbage microgreens and Red beet microgreens in Aging, Menopause and Healthy, sponsored by Colorado State University. Completed at 1 site in United States. Open to participants aged 45 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-19.

Sponsored by Colorado State University · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Jul 2019, registered Nov 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
26
Allocation
Randomized
Ages
45 Years to 70 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Aging
  • Menopause
  • Healthy
03

In context

Lead sponsor

Colorado State University is the lead sponsor of 116 studies on the registry; 20 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Male or postmenopausal
  • Aged 45-70

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Outcomes assessor)
Enrollment
26 participants (actual)

Study arms

  • Experimental
    Red cabbage microgreens

    2 cups of fresh red cabbage microgreens per day

    Other: Red cabbage microgreens

  • Experimental
    Red beet microgreens

    2 cups of fresh red beet microgreens per day

    Other: Red beet microgreens

Interventions

  • OtherRed cabbage microgreens

    2 cups per day

  • OtherRed beet microgreens

    2 cups per day

06

What researchers measure

Primary outcomes

  1. Number of participants retained

    The number of participants retained versus lost to follow-up throughout the entire study

    Time frame: Baseline to 6 weeks

  2. Adherence to the intervention

    Adherence will be determined for each 2-week microgreen intervention through a daily microgreen consumption log

    Time frame: Baseline to 2 weeks

Secondary outcomes

  1. Gastrointestinal symptom self-assessment

    Determine the effects on gastrointestinal symptoms using a validated questionnaire for each 2-week microgreen intervention

    Time frame: Baseline to 2 weeks

  2. Gastrointestinal health

    Determine the effects on gastrointestinal health using a daily bowel movement log for each 2-week microgreen intervention

    Time frame: Baseline to 2 weeks

  3. Blood pressure

    Determine the effects on brachial and aortic blood pressure measured by SphygmoCor for each 2-week microgreen intervention

    Time frame: Baseline to 2 weeks

  4. Augmentation index

    Determine the effects on augmentation index measured by SphygmoCor for each 2-week microgreen intervention

    Time frame: Baseline to 2 weeks

  5. Microbiota modulation

    Use of 16s rRNA sequencing of stool samples to determine the effects of each 2-week microgreen intervention on microbial populations

    Time frame: Baseline to 2 weeks

  6. Acceptability

    Determine acceptability and feasibility of daily microgreen consumption through qualitative interviews with study participants at completion of the 2-week study

    Time frame: 2-week visit

Other outcomes

  1. Changes in plasma metabolites

    Use of mass spectrometry to determine the effects on plasma metabolites of bioactive compounds for each 2-week microgreen intervention

    Time frame: Baseline to 2 weeks

07

Study locations

1 site
  • Department of Food Science and Human Nutrition, Colorado State University
    Fort Collins, Colorado 80523-1571, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04239898
Responsible party
Sponsor
First posted
Jan 27, 2020
Start date
Jul 16, 2019
Primary completion
Nov 22, 2019
Completion
Nov 30, 2019
Last update
Sep 19, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

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