BiomarkersNCT05837858
The Human Metabolic Profile and Gut Microbiota Under Various Dietary Quality
A study testing whole grain-wheat flour food+standardized meals and refined wheat flour food+standardized meals in people with Biomarkers, run by Peking University at 1 site in China.
Trial summary
The goal of this food intervention study is to screen/validate the whole grain food intake biomarker in health Chinese's population. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Biomarkers
- What is being tested?
- whole grain-wheat flour food+standardized meals and refined wheat flour food+standardized meals
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 28 Apr 2023to 24 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy men and women
- age 18-40 years
- BMI 18.5-23.9 kg/m2.
Who cannot join
- pregnancy or breastfeeding
- vegetarian;
- smokers;
- acute and chronic diseases;
- allergic to wheat;
- frequent nutrients supplement use;
Show all 9Show fewer
- medication use of antibiotics within 1-month;
- more than 3 kg weight change within 3-month;
- unwillingness to follow dietary restrictions;
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Nutrition and Food Hygiene, School of Public Health, Peking University
Beijing
About this study
Official title: Study on Biomarkers of Whole Grain Dietary Intake in Chinese Population
The goal of this food intervention study is to screen/validate the whole grain food intake biomarker in health Chinese's population.
Read the detailed description
Although increased consumption of whole grains (WGs) is associated with improved health outcomes, the dietary intake assessment and health mechanisms for WGs or WG-containing food remain unresolved. In addition, information regarding its consumption and health effects in Chinese people is scarce. Biomarkers of WGs intake would allow a more accurate assessment of its consumption in nutrition studies. The investigators want to perform a crossover study where participants were subjected to a WG-wheat flour or a refine wheat-flour Chinese diet. Using a metabolomics approach, the investigators aimed to identify the WG-specific metabolites present in plasma/urine after consumption WG or WG foods, including new candidate biomarkers of WG intake.
- Conditions
- Biomarkers
- Being tested
- whole grain-wheat flour food+standardized meals, refined wheat flour food+standardized meals
- Keywords
- Food biomarker, Whole grain, Chinese population
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
whole grain-wheat flour food+standardized mealsOther
whole grain food made by 50 g whole grain wheat flour
refined wheat flour food+standardized mealsOther
refined grain food made by 50 g refined wheat flour
| Study group | Role | What they receive |
|---|---|---|
| whole grain-wheat flour food, then refined wheat flour food | Experimental | Participants first received food made by 50 g whole grain wheat flour during breakfast in a fasting state. Standardized meals were provided to the volunteers from the dinner of the day before the intervention day, as well as up to 48 h after the administration of the test food. After a washout period of 5 days, volunteers followed a 2-day restricted diet before the intervention day. Participants then received food made by 50 g refined grain wheat flour in a fasting state. Receives: Other: whole grain-wheat flour food+standardized meals; Other: refined wheat flour food+standardized meals |
| refined wheat flour food, then whole grain-wheat flour food | Experimental | Participants first received food made by 50 g refined grain wheat flour during breakfast in a fasting state. Standardized meals were provided to the volunteers from the dinner of the day before the intervention day, as well as up to 48 h after the administration of the test food. After a washout period of 5 days, volunteers followed a 2-day restricted diet before the intervention day. Participants then received food made by 50 g whole grain wheat flour in a fasting state. Receives: Other: whole grain-wheat flour food+standardized meals; Other: refined wheat flour food+standardized meals |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in metabolite profiles present in blood plasma and urine before the dietary intervention and in kinetics over 24 hours.
Metabolite profiles analyzed using a non-targeted metabolomics approach and targeted metabolomics approach with a Orbitrap Mass Analyzer. Blood plasma samples collected at time 0 hours, 2 hours, 4 hours, and 24 hours. Urine fractions collected at 0-2 hours, 2-4 hours, 4-6 hours, 6-9 hours, 9-12 hours, 12-24 hours and 24-48 hours. Identification of biomarkers of acute intake of the foods of interest through the comparison of specific metabolomes after single dose of WG food or refined grain food in Chinese population.
Measured: Baseline and 0-24 hours after intervention food intake
Secondary outcomes (1)
The influence of gut flora on whole grain markers
Gut flora abundance and metabolites level correlation analysis
Measured: after the administration of the test meal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study start28 Apr 2023
- Primary completion24 May 2023
- Study completion24 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BiomarkersStudies of the same condition, open and under way.
- More trials run by Peking UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized Crossover Assignment
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yunjia yang, Principal investigator, Peking UniversityYalin Zhou, Principal investigator, Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05837858
- Sponsor's protocol ID
- xuyajun197673
- Status last verified
- Apr 2023
- First submitted
- 20 Apr 2023
- Last updated
- 3 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Shared IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Biomarkers of Whole Grain Dietary Intake in Chinese Population
- ClinicalTrials.gov ID
- NCT05837858
- Acronym / sponsor ID
- xuyajun197673
- Conditions
- Biomarkers
- Keywords
- Food biomarker, Whole grain, Chinese population
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- 28 Apr 2023 (actual)
- Primary completion
- 24 May 2023 (actual)
- Study completion
- 24 May 2023 (actual)
- First posted
- 1 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this food intervention study is to screen/validate the whole grain food intake biomarker in health Chinese's population.
Detailed description
Although increased consumption of whole grains (WGs) is associated with improved health outcomes, the dietary intake assessment and health mechanisms for WGs or WG-containing food remain unresolved. In addition, information regarding its consumption and health effects in Chinese people is scarce. Biomarkers of WGs intake would allow a more accurate assessment of its consumption in nutrition studies. The investigators want to perform a crossover study where participants were subjected to a WG-wheat flour or a refine wheat-flour Chinese diet. Using a metabolomics approach, the investigators aimed to identify the WG-specific metabolites present in plasma/urine after consumption WG or WG foods, including new candidate biomarkers of WG intake.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Crossover Assignment
| Arm | Type | Receives |
|---|---|---|
| whole grain-wheat flour food, then refined wheat flour food | Experimental | Other: whole grain-wheat flour food+standardized meals, Other: refined wheat flour food+standardized mealsParticipants first received food made by 50 g whole grain wheat flour during breakfast in a fasting state. Standardized meals were provided to the volunteers from the dinner of the day before the intervention day, as well as up to 48 h after the administration of the test food. After a washout period of 5 days, volunteers followed a 2-day restricted diet before the intervention day. Participants then received food made by 50 g refined grain wheat flour in a fasting state. |
| refined wheat flour food, then whole grain-wheat flour food | Experimental | Other: whole grain-wheat flour food+standardized meals, Other: refined wheat flour food+standardized mealsParticipants first received food made by 50 g refined grain wheat flour during breakfast in a fasting state. Standardized meals were provided to the volunteers from the dinner of the day before the intervention day, as well as up to 48 h after the administration of the test food. After a washout period of 5 days, volunteers followed a 2-day restricted diet before the intervention day. Participants then received food made by 50 g whole grain wheat flour in a fasting state. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy men and women
- age 18-40 years
- BMI 18.5-23.9 kg/m2.
Key exclusion criteria (9 listed)
- pregnancy or breastfeeding
- vegetarian;
- smokers;
- acute and chronic diseases;
- allergic to wheat;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| whole grain-wheat flour food+standardized mealswhole grain food made by 50 g whole grain wheat flour | Other | refined wheat flour food, then whole grain-wheat flour food, whole grain-wheat flour food, then refined wheat flour food |
| refined wheat flour food+standardized mealsrefined grain food made by 50 g refined wheat flour | Other | refined wheat flour food, then whole grain-wheat flour food, whole grain-wheat flour food, then refined wheat flour food |
Primary outcome
Changes in metabolite profiles present in blood plasma and urine before the dietary intervention and in kinetics over 24 hours.
Time frame: Baseline and 0-24 hours after intervention food intake
Metabolite profiles analyzed using a non-targeted metabolomics approach and targeted metabolomics approach with a Orbitrap Mass Analyzer. Blood plasma samples collected at time 0 hours, 2 hours, 4 hours, and 24 hours. Urine fractions collected at 0-2 hours, 2-4 hours, 4-6 hours, 6-9 hours, 9-12 hours, 12-24 hours and 24-48 hours. Identification of biomarkers of acute intake of the foods of interest through the comparison of specific metabolomes after single dose of WG food or refined grain food in Chinese population.
1 secondary outcome
The influence of gut flora on whole grain markers
Time frame: after the administration of the test meal
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2023.
- Individual participant dataSharing planned: Yes. Shared IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yunjia yang principal investigator
Peking University
Yalin Zhou principal investigator
Peking University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing whole grain-wheat flour food+standardized meals and refined wheat flour food+standardized meals in people with Biomarkers, run by Peking University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in metabolite profiles present in blood plasma and urine before the dietary intervention and in kinetics over 24 hours. (time frame: Baseline and 0-24 hours after intervention food intake). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2023.