Microgreen Consumption for Healthy Aging

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04239898
• Other study ID #: MG2019
• Status: Completed
• Phase: N/A
• Start date: July 16, 2019
• Est. completion date: November 30, 2019

Study information

• Verified date: September 2019
• Source: Colorado State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: November 30, 2019
• Est. primary completion date: November 22, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Aging
• Healthy
• Menopause

Intervention

Other:
• Red cabbage microgreens
2 cups per day
• Red beet microgreens
2 cups per day

Locations

Country	Name	City	State
United States	Department of Food Science and Human Nutrition, Colorado State University	Fort Collins	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Colorado State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants retained	The number of participants retained versus lost to follow-up throughout the entire study	Baseline to 6 weeks
Primary	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	Gastrointestinal symptom self-assessment	Determine the effects on gastrointestinal symptoms using a validated questionnaire for each 2-week microgreen intervention	Baseline to 2 weeks
Secondary	Gastrointestinal health	Determine the effects on gastrointestinal health using a daily bowel movement log for each 2-week microgreen intervention	Baseline to 2 weeks
Secondary	Blood pressure	Determine the effects on brachial and aortic blood pressure measured by SphygmoCor for each 2-week microgreen intervention	Baseline to 2 weeks
Secondary	Augmentation index	Determine the effects on augmentation index measured by SphygmoCor for each 2-week microgreen intervention	Baseline to 2 weeks
Secondary	Microbiota modulation	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
Secondary	Changes in plasma metabolites	Use of mass spectrometry to determine the effects on plasma metabolites of bioactive compounds for each 2-week microgreen intervention	Baseline to 2 weeks
Secondary	Acceptability	Determine acceptability and feasibility of daily microgreen consumption through qualitative interviews with study participants at completion of the 6-week study	6-week visit