Vegetable Signature From Human Metabolomics Responses

Not Applicable

Completed

• Conditions: Vegetable Signature Documentation With Metabolomic Technique
• Interventions: Other: Onion; Other: Celery; Other: Control; Other: Mixed Vegetables; Other: Spinach

• Registration Number: NCT03483558
• Lead Sponsor: National Health Research Institutes, Taiwan

Brief Summary

The purpose of this study is to perform dietary intervention studies on a variety of vegetables.

Detailed Description

Plant-based foods have always been an important component of a healthy diet. High intake of plant foods may not only maintain normal bodily functions through the provision of dietary fiber, vitamins, and minerals but also relieve symptoms and prevent diseases. Many studies have pointed out that high intake of plant foods may reduce the incidence of non-communicable disease. Past research investigating the effect of phytochemicals has usually been limited to single substances or single foods. However, a number of researchers have pointed out that phytonutrients and dietary components are likely to act synergistically.Health effects and mechanisms of phytonutrients in combination have not been carefully studied in population settings. The technology of metabolomics has enabled the simultaneous measurement of hundreds of small molecules in biological samples. Exploring the change of metabolites after feeding can not only help us understand the role of plant foods, but may also provide opportunities to assess plant food intake levels.

Study Timeline

• Study Start: 2011-06-11
• Primary Completion: 2012-12-31
• Study Completion: 2015-05-28
• Status Verified: 2018-01
• Study First Submitted: 2018-01-31
• Study First Submitted QC: 2018-03-28
• Last Update Submitted: 2018-03-28
• Study First Posted: 2018-03-30
• Last Update Posted: 2018-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

• BMI 18.5~30 kg/m2
• non-smoker
• non-alcoholic

Exclusion Criteria

• Unwilling to stop taking the dietary supplements that may affect the experiment result.
• Unwilling to take the provided meal during the designated period.
• Taking hypertension or diabetes drugs.
• Diagnosed immune diseases (such as allergic diseases, autoimmune diseases, etc.), liver diseases, metabolic diseases (such as hyperthyroidism or hypothyroidism), or other not suitable for the dietary study.
• Diagnosed cancer or other severe diseases.
• Suffered from urinary tract infection or took antibiotic in the past three months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Onion	Onion	Participants were fed a standardized diet with 200g onion in this experiment.
Celery	Celery	Participants were fed a standardized diet with 200g celery in this experiment.
Control	Control	Participants were fed a standardized diet (without any vegetables) in this experiment.
Mixed Vegetables	Mixed Vegetables	Participants were fed a standardized diet with 200g of mixed vegetables (spinach, celery, and onion) in this experiment.
Spinach	Spinach	Participants were fed a standardized diet with 200g spinach in this experiment.

Primary Outcome Measures

Name	Time	Method
Intensities of multiple serum metabolites	11.5 hours (after lunch at 19:00PM)	The outcome measure consists of intensities of multiple serum metabolites from a liquid chromatography/time-of-flight/mass spectrometry (LC/TOF/MS) experiment. Intensity means the level of response variable (a given metabolite) showing the degree of response detected by LC/TOF/MS.
Intensities of multiple urinary metabolites	8.5~11.5 hours (7-hour after lunch urine sample collected from 16:00 to 19:00PM)	The outcome measure consists of intensities of multiple urinary metabolites from a liquid chromatography/time-of-flight/mass spectrometry (LC/TOF/MS) experiment. Intensity means the level of response variable (a given metabolite) showing the degree of response detected by LC/TOF/MS.