Chronic Disease PreventionNCT06358781
A Dose-response Study to Validate the Biomarkers for Whole Grain Dietary Intake
A study testing Whole grain wheat flour in people with Chronic Disease Prevention, run by Peking University at 1 site in China.
Trial summary
Dose-response validation of whole grain dietary intake biomarkers remains limited, and it is debatable whether these markers could be utilized as classifiers for different levels of whole grain consumption. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Disease Prevention
- What is being tested?
- Whole grain wheat flour
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteChina
- Study dates
- 19 Apr 2024to 13 May 2024
- 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: Screening Whole Grain Dietary Intake Biomarkers and Validating the Dose-response Relationship in a Randomized Controlled Study in China.
Dose-response validation of whole grain dietary intake biomarkers remains limited, and it is debatable whether these markers could be utilized as classifiers for different levels of whole grain consumption. Because there are significant disparities in genetic background and dietary patterns between Chinese and Western cultures, it is unclear if whole grain dietary intake biomarkers can characterize whole grain consumption in Chinese populations. To address these issues, the current study was designed to evaluate the sensitivity and specificity of potential whole grain markers in a randomized controlled trial, as well as to validate the markers' dose-response relationship, so that they can be used in nutritional epidemiological studies and dietary intake assessments of whole grains.
Read the detailed description
An acute randomized controlled trial was performed and the total study group is randomly divided into four groups: the amounts of WG wheat flour administered were 0 g, 25g, 50 g and 100 g. Experimental period with a total of 6 days was subdivided into two parts: -5 days to 0 h defined as the run-in period, 0-24 h (after the dose-related test meal), defined as the test day.
- Conditions
- Chronic Disease Prevention
- Being tested
- Whole grain wheat flour
- Keywords
- Whole grain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole grain wheat flourOther
Group A: whole grain flour: 0 g Group B: Whole grain flour: 25 g Group C: Whole grain flour: 50 g Group D: whole grain flour: 100g
| Study group | Role | What they receive |
|---|---|---|
| Group A (WG wheat flour intake= 0 g) | No intervention | An acute randomized controlled trial was performed and the total study group is randomly divided into four groups: the amounts of WG wheat flour for group A were 0 g. |
| Group B (WG wheat flour intake= 25 g) | Experimental | An acute randomized controlled trial was performed and the total study group is randomly divided into four groups: the amounts of WG wheat flour for group B were 25 g. Receives: Other: Whole grain wheat flour |
| Group C (WG wheat flour intake= 50 g) | Experimental | An acute randomized controlled trial was performed and the total study group is randomly divided into four groups: the amounts of WG wheat flour for group C were 50 g. Receives: Other: Whole grain wheat flour |
| Group D (WG wheat flour intake= 100 g) | Experimental | An acute randomized controlled trial was performed and the total study group is randomly divided into four groups: the amounts of WG wheat flour for group D were 100 g. Receives: Other: Whole grain wheat flour |
What is being measured
The primary outcome is the main question the study is designed to answer.
whole grain plasma and urine biomarkers discovery and identification
Discovery of whole grain plasma and urine biomarkers after acute intakes of WG wheat food using LC-MS untargeted metabolomics approach in a designed study, identify the specific biomarkers for WG wheat with high confidence levels.
Measured: Baseline and 0~24 hours after intervention food intake
Secondary outcomes (1)
Validate the performance of the potential WG biomarkers.
The receiver operating characteristic analysis was used to validate the performance of the potential WG biomarkers in the dose-response validation set
Measured: Baseline and 0~24 hours after intervention food intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study start19 Apr 2024
- Primary completion13 May 2024
- Study completion13 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Disease PreventionStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yajun Xu, Study director, Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06358781
- Sponsor's protocol ID
- xuyajun197673-002
- Status last verified
- Apr 2024
- First submitted
- 7 Apr 2024
- Last updated
- 22 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Shared results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening Whole Grain Dietary Intake Biomarkers and Validating the Dose-response Relationship in a Randomized Controlled Study in China.
- ClinicalTrials.gov ID
- NCT06358781
- Acronym / sponsor ID
- xuyajun197673-002
- Conditions
- Chronic Disease Prevention
- Keywords
- Whole grain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- 19 Apr 2024 (actual)
- Primary completion
- 13 May 2024 (actual)
- Study completion
- 13 May 2024 (actual)
- First posted
- 11 Apr 2024 (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.
Dose-response validation of whole grain dietary intake biomarkers remains limited, and it is debatable whether these markers could be utilized as classifiers for different levels of whole grain consumption. Because there are significant disparities in genetic background and dietary patterns between Chinese and Western cultures, it is unclear if whole grain dietary intake biomarkers can characterize whole grain consumption in Chinese populations. To address these issues, the current study was designed to evaluate the sensitivity and specificity of potential whole grain markers in a randomized controlled trial, as well as to validate the markers' dose-response relationship, so that they can be used in nutritional epidemiological studies and dietary intake assessments of whole grains.
Detailed description
An acute randomized controlled trial was performed and the total study group is randomly divided into four groups: the amounts of WG wheat flour administered were 0 g, 25g, 50 g and 100 g. Experimental period with a total of 6 days was subdivided into two parts: -5 days to 0 h defined as the run-in period, 0-24 h (after the dose-related test meal), defined as the test day.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A (WG wheat flour intake= 0 g) | No intervention | –An acute randomized controlled trial was performed and the total study group is randomly divided into four groups: the amounts of WG wheat flour for group A were 0 g. |
| Group B (WG wheat flour intake= 25 g) | Experimental | Other: Whole grain wheat flourAn acute randomized controlled trial was performed and the total study group is randomly divided into four groups: the amounts of WG wheat flour for group B were 25 g. |
| Group C (WG wheat flour intake= 50 g) | Experimental | Other: Whole grain wheat flourAn acute randomized controlled trial was performed and the total study group is randomly divided into four groups: the amounts of WG wheat flour for group C were 50 g. |
| Group D (WG wheat flour intake= 100 g) | Experimental | Other: Whole grain wheat flourAn acute randomized controlled trial was performed and the total study group is randomly divided into four groups: the amounts of WG wheat flour for group D were 100 g. |
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 flourGroup A: whole grain flour: 0 g Group B: Whole grain flour: 25 g Group C: Whole grain flour: 50 g Group D: whole grain flour: 100g | Other | Group B (WG wheat flour intake= 25 g), Group C (WG wheat flour intake= 50 g), Group D (WG wheat flour intake= 100 g) |
Primary outcome
whole grain plasma and urine biomarkers discovery and identification
Time frame: Baseline and 0~24 hours after intervention food intake
Discovery of whole grain plasma and urine biomarkers after acute intakes of WG wheat food using LC-MS untargeted metabolomics approach in a designed study, identify the specific biomarkers for WG wheat with high confidence levels.
1 secondary outcome
Validate the performance of the potential WG biomarkers.
Time frame: Baseline and 0~24 hours after intervention food intake
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 22 May 2024.
- Individual participant dataSharing planned: Yes. Shared results in a publication
Related trials for Chronic Disease Prevention
Active, not recruiting
Intra-Nasal Mechanical Stimulation (INMEST) as a Potential Preventative Treatment for Migraine
Migraine
Not yet recruiting
Multicomponent Exercise and Pain Science Education for Fall Prevention in Older Adults With Chronic Musculoskeletal Pain (MovePainFall)
Chronic Pain, Musculoskeletal Pain
RecruitingPhase 2
CMV-MVA Triplex Vaccination in HLA-Matched Related Stem Cell Donors for the Prevention of CMV Infection in Patients Undergoing Hematopoietic Stem Cell Transplant
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
RecruitingPhase 1
A Vaccine (CMV-MVA Triplex Vaccine) for the Enhancement of CMV-Specific Immunity and the Prevention of CMV Viremia in Patients Undergoing Haploidentical Hematopoietic Stem Cell Transplant
Accelerated Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive, Acute Lymphoblastic Leukemia
Active, not recruitingPhase 3
A Study to Learn About the Study Medicine Called Rimegepant in Adolescents With Frequent Migraine
Migraine
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.
Yajun Xu study director
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 in people with Chronic Disease Prevention, 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 22 May 2024. 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?
whole grain plasma and urine biomarkers discovery and identification (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 22 May 2024.