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OpenTrials
Completed

NCT Number: NCT04239898

Microgreen Consumption for Healthy Aging

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.

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Key information

Conditions

Aging Healthy Menopause

Age range

45 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Food Science and Human Nutrition, Colorado State University

Fort Collins, Colorado, 80523-1571, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Red cabbage microgreens

Other

2 cups per day

Red beet microgreens

Other

2 cups per day

Primary outcomes

  1. Number of participants retained

    Time frame: Baseline to 6 weeks

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

  2. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. Augmentation index

    Time frame: Baseline to 2 weeks

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

  5. 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

  6. Acceptability

    Time frame: 2-week visit

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

Other outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Colorado State University

Other

Registry information

Official study title

Feasibility, Acceptability, Tolerability, and Potential Health Effects of Microgreen Consumption in Healthy Middle-Aged and Older Adults

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jan 27, 2020
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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