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Completed

NCT Number: NCT03483558

Vegetable Signature From Human Metabolomics Responses

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

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Control

Other

A standardized diet without any vegetables was provided.

Spinach

Other

A standardized diet with 200g spinach was provided.

Celery

Other

A standardized diet with 200g celery was provided.

Onion

Other

A standardized diet with 200g onion was provided.

Mixed Vegetables

Other

A standardized diet with 200g of mixed vegetables (spinach, celery, and onion) was provided.

Primary outcomes

  1. Intensities of multiple serum metabolites

    Time frame: Baseline (fasting state before breakfast at 7:30AM)

    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.

  2. Intensities of multiple serum metabolites

    Time frame: 4 Hours (immediately before lunch at 11:30AM)

    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.

  3. Intensities of multiple serum metabolites

    Time frame: 5.5 hours (after lunch at 13:00PM)

    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.

  4. Intensities of multiple serum metabolites

    Time frame: 6.5 hours (after lunch at 14:00 PM)

    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.

  5. Intensities of multiple serum metabolites

    Time frame: 7.5 hours (after lunch at 15:00PM)

    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.

  6. Intensities of multiple serum metabolites

    Time frame: 8.5 hours (after lunch at 16:00PM)

    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.

  7. Intensities of multiple serum metabolites

    Time frame: 9.5 hours (after lunch at 17:00PM)

    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.

  8. Intensities of multiple serum metabolites

    Time frame: 10.5 hours (after lunch at 18:00PM)

    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.

  9. Intensities of multiple serum metabolites

    Time frame: 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.

  10. Intensities of multiple urinary metabolites

    Time frame: Baseline (overnight urine sample collected at 7:30AM)

    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.

  11. Intensities of multiple urinary metabolites

    Time frame: 3.5~4 hours (before lunch urine sample collected during 11:00~11:30AM)

    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.

  12. Intensities of multiple urinary metabolites

    Time frame: 4.5~6.5 hours (2-hour after lunch urine sample collected from 12:00 to 14:00PM)

    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.

  13. Intensities of multiple urinary metabolites

    Time frame: 6.5~8.5 hours (4-hour after lunch urine sample collected from 14:00 to 16:00PM)

    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.

  14. Intensities of multiple urinary metabolites

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

National Health Research Institutes, Taiwan

Other

Collaborators

  • Academia Sinica, Taiwan
  • Fu Jen Catholic University
  • Tri-Service General Hospital (TSGH)

Registry information

Official study title

Dietary Intervention Studies on a Variety of Vegetables

Important dates

Study start
2011
Primary completion
2012
Study completion
2015
First posted
Mar 30, 2018
Registry last updated
Mar 30, 2018

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.