Clinical trial NCT03483558: Vegetable Signature From Human Metabolomics Responses
Official title: Dietary Intervention Studies on a Variety of Vegetables
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vegetable Signature Documentation With Metabolomic Technique
Keywords: vegetable metabolite signature
human serum/urinary metabolite
liquid chromatography mass spectrometry
Lead sponsor: National Health Research Institutes, Taiwan
Sponsor class: OTHER
Collaborators: name: Academia Sinica, Taiwan
name: Tri-Service General Hospital
name: Fu Jen Catholic University
First posted: 2018-03-30
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Intensities of multiple serum metabolites
timeFrame: Baseline (fasting state before breakfast at 7:30AM)
measure: Intensities of multiple serum metabolites
timeFrame: 4 Hours (immediately before lunch at 11:30AM)
measure: Intensities of multiple serum metabolites
timeFrame: 5.5 hours (after lunch at 13:00PM)
measure: Intensities of multiple serum metabolites
timeFrame: 6.5 hours (after lunch at 14:00 PM)
measure: Intensities of multiple serum metabolites
timeFrame: 7.5 hours (after lunch at 15:00PM)
measure: Intensities of multiple serum metabolites
timeFrame: 8.5 hours (after lunch at 16:00PM)
measure: Intensities of multiple serum metabolites
timeFrame: 9.5 hours (after lunch at 17:00PM)
measure: Intensities of multiple serum metabolites
timeFrame: 10.5 hours (after lunch at 18:00PM)
measure: Intensities of multiple serum metabolites
timeFrame: 11.5 hours (after lunch at 19:00PM)
measure: Intensities of multiple urinary metabolites
timeFrame: Baseline (overnight urine sample collected at 7:30AM)
measure: Intensities of multiple urinary metabolites
timeFrame: 3.5~4 hours (before lunch urine sample collected during 11:00~11:30AM)
measure: Intensities of multiple urinary metabolites
timeFrame: 4.5~6.5 hours (2-hour after lunch urine sample collected from 12:00 to 14:00PM)
measure: Intensities of multiple urinary metabolites
timeFrame: 6.5~8.5 hours (4-hour after lunch urine sample collected from 14:00 to 16:00PM)
measure: Intensities of multiple urinary metabolites
timeFrame: 8.5~11.5 hours (7-hour after lunch urine sample collected from 16:00 to 19:00PM)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: National Health Research Institutes, Taiwan
name: Wen-Harn Pan, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: