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

Conditions

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.

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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