Clinical trial NCT04239898: Microgreen Consumption for Healthy Aging
Official title: Feasibility, Acceptability, Tolerability, and Potential Health Effects of Microgreen Consumption in Healthy Middle-Aged and Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Menopause
Healthy
Lead sponsor: Colorado State University
Sponsor class: OTHER
First posted: 2020-01-27
Enrollment: 26
Sex: ALL
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of participants retained
timeFrame: Baseline to 6 weeks
measure: Adherence to the intervention
timeFrame: Baseline to 2 weeks
Secondary outcomes:
measure: Gastrointestinal symptom self-assessment
timeFrame: Baseline to 2 weeks
measure: Gastrointestinal health
timeFrame: Baseline to 2 weeks
measure: Blood pressure
timeFrame: Baseline to 2 weeks
measure: Augmentation index
timeFrame: Baseline to 2 weeks
measure: Microbiota modulation
timeFrame: Baseline to 2 weeks
measure: Acceptability
timeFrame: 2-week visit
Other outcomes:
measure: Changes in plasma metabolites
timeFrame: Baseline to 2 weeks
Locations:
city: Fort Collins
country: United States
facility: Department of Food Science and Human Nutrition, Colorado State University
state: Colorado
Study officials:
References: