Microgreen Consumption for Healthy Aging

NCT04239898 | Completed

• 1 other identifier: MG2019
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Aging; Menopause; Healthy

Outcome Measures

Primary Outcomes (2)

• Number of participants retained

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

  Baseline to 6 weeks

• Adherence to the intervention

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

  Baseline to 2 weeks

Secondary Outcomes (6)

• Gastrointestinal symptom self-assessment

  Baseline to 2 weeks

• Gastrointestinal health

  Baseline to 2 weeks

• Blood pressure

  Baseline to 2 weeks

• Augmentation index

  Baseline to 2 weeks

• Microbiota modulation

  Baseline to 2 weeks

Other Outcomes (1)

• Changes in plasma metabolites

  Baseline to 2 weeks

Study Arms (2)

Red cabbage microgreens

EXPERIMENTAL

2 cups of fresh red cabbage microgreens per day

Other: Red cabbage microgreens

Red beet microgreens

EXPERIMENTAL

2 cups of fresh red beet microgreens per day

Other: Red beet microgreens

Interventions

Red cabbage microgreens OTHER

2 cups per day

Red cabbage microgreens

Red beet microgreens OTHER

2 cups per day

Red beet microgreens

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or postmenopausal
• Aged 45-70

You may not qualify if:

• 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

Sponsors & Collaborators

• Colorado State University: lead

Study Sites (1)

Department of Food Science and Human Nutrition, Colorado State University

Fort Collins, Colorado, 80523-1571, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2019
• First Posted: January 27, 2020
• Study Start: July 16, 2019
• Primary Completion: November 22, 2019
• Study Completion: November 30, 2019
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

US (1)