Metabolism and Nutrition DisorderPhase 2NCT06422429
Study on the Regulatory Effects of Personalized Innovative Youtiao Intervention on Nutritional Health
A Phase 2 study testing Traditional deep-fried Youtiao and PI Youtiao in people with Metabolism and Nutrition Disorder, run by Yu Zhang.
Trial summary
The goal of this clinical trial is to investigate the effects of personalized innovative fritters on the nutritional health of overweight and obese individuals aged 40 to 70 years. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Metabolism and Nutrition Disorder
- What is being tested?
- Traditional deep-fried Youtiao and PI Youtiao
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2025to 1 Dec 2025
- Phase
- Phase 2
- 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 40-70 years old (women need to be menopausal);
- BMI>24 kg/m2;
- Consumption of fritters more than once a week.
Who cannot join
- history of diabetes mellitus, cardiovascular disease, dyslipidaemia, renal disease, -
- liver disease or cancer;
- surgical treatment within 3 months;
- allergy/intolerance to the study food or any of its ingredients;
- breastfeeding or pregnancy;
- >10% weight loss in the past 6 months;
- smoking or alcohol abuse;
- participation in another clinical study within the past 6 months
Trial locations and contacts
No sites are listed yet.
About this study
The goal of this clinical trial is to investigate the effects of personalized innovative fritters on the nutritional health of overweight and obese individuals aged 40 to 70 years. The main questions it aims to answer are:
- How does consuming personalized innovative fritters affect the nutritional health of overweight and obese individuals?
- What is the mechanism underlying the impact of personalized innovative oil bars on nutritional health?
Read more
Participants will be randomly assigned to one of two groups: a trial group consuming personalized innovative fritters and a control group consuming traditional fritters with equal energy content. Over the course of 6 months, participants will undergo two phases of intervention separated by a two-month washout period. During the intervention, participants will be assessed comprehensively for sensory ratings and nutritional health status through biological indicators, physical examinations, and other relevant measures.
Researchers will compare the trial group to the control group to determine if personalized innovative fritters lead to improvements in nutritional health compared to traditional fritters.
Read the detailed description
Participants entered the trial with a 1-week equilibration period during which baked and fried foods were prohibited. The test group will consume personalised innovative Youtiao and the control group will uniformly consume traditional Youtiao of equal energy, 45 g 4 times per week for 8 weeks, during which time we will periodically measure biological indicators and collect biological samples to gain insight into the effects of the personalised innovative Youtiao on the participants. After completion of the 8-week intervention, a washout phase is entered. During this phase, participants will no longer ingest the Youtiao to see how they trend after stopping the intervention. Participants then enter the second phase of the trial, where the intervention process described above is continued with appropriate consumption adjustments based on the initial results of the first phase of the intervention.
- Conditions
- Metabolism and Nutrition Disorder
- Being tested
- Traditional deep-fried Youtiao, PI Youtiao
- Medical subject headings
- Nutrition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional deep-fried YoutiaoDrug
45g 4 times a week for 4 months
PI YoutiaoDrug
45g 4 times a week for 4 months
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | traditional Youtiao Receives: Drug: Traditional deep-fried Youtiao |
| Intervention group | Experimental | Personalised and innovative Youtiao Receives: Drug: PI Youtiao |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c
The investigators will measure HbA1c in blood samples before and after treatment.
Measured: 6 months
Change in blood glucose from baseline
The investigators will measure fasting plasma glucose levels in blood samples before and after treatment.
Measured: 6 months
Secondary outcomes (1)
Change in blood lipids from baseline
The investigators will measure Triglycerides (TG), total cholesterol (TC), LDL-C, and HDL-C levels in blood samples before and after treatment.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2024
- Study start1 Mar 2025 (estimated)
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolism and Nutrition DisorderStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yu Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yu Zhang, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06422429
- Sponsor's protocol ID
- RCT_PI Youtiao
- Status last verified
- Jan 2024
- First submitted
- 17 Jan 2024
- Last updated
- 21 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Regulatory Effects of Personalized Innovative Youtiao Intervention on Nutritional Health
- ClinicalTrials.gov ID
- NCT06422429
- Acronym / sponsor ID
- RCT_PI Youtiao
- Conditions
- Metabolism and Nutrition Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Yu ZhangUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 21 May 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.
The goal of this clinical trial is to investigate the effects of personalized innovative fritters on the nutritional health of overweight and obese individuals aged 40 to 70 years. The main questions it aims to answer are:
- How does consuming personalized innovative fritters affect the nutritional health of overweight and obese individuals?
- What is the mechanism underlying the impact of personalized innovative oil bars on nutritional health?
Participants will be randomly assigned to one of two groups: a trial group consuming personalized innovative fritters and a control group consuming traditional fritters with equal energy content. Over the course of 6 months, participants will undergo two phases of intervention separated by a two-month washout period. During the intervention, participants will be assessed comprehensively for sensory ratings and nutritional health status through biological indicators, physical examinations, and other relevant measures.
Researchers will compare the trial group to the control group to determine if personalized innovative fritters lead to improvements in nutritional health compared to traditional fritters.
Detailed description
Participants entered the trial with a 1-week equilibration period during which baked and fried foods were prohibited. The test group will consume personalised innovative Youtiao and the control group will uniformly consume traditional Youtiao of equal energy, 45 g 4 times per week for 8 weeks, during which time we will periodically measure biological indicators and collect biological samples to gain insight into the effects of the personalised innovative Youtiao on the participants. After completion of the 8-week intervention, a washout phase is entered. During this phase, participants will no longer ingest the Youtiao to see how they trend after stopping the intervention. Participants then enter the second phase of the trial, where the intervention process described above is continued with appropriate consumption adjustments based on the initial results of the first phase of the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Drug: Traditional deep-fried Youtiaotraditional Youtiao |
| Intervention group | Experimental | Drug: PI YoutiaoPersonalised and innovative Youtiao |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age between 40-70 years old (women need to be menopausal);
- BMI>24 kg/m2;
- Consumption of fritters more than once a week.
Key exclusion criteria (8 listed)
- history of diabetes mellitus, cardiovascular disease, dyslipidaemia, renal disease, -
- liver disease or cancer;
- surgical treatment within 3 months;
- allergy/intolerance to the study food or any of its ingredients;
- breastfeeding or pregnancy;
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 |
|---|---|---|
| Traditional deep-fried Youtiao45g 4 times a week for 4 months | Drug | Control group |
| PI Youtiao45g 4 times a week for 4 months | Drug | Intervention group |
Primary outcome
Change in HbA1c
Time frame: 6 months
The investigators will measure HbA1c in blood samples before and after treatment.
Change in blood glucose from baseline
Time frame: 6 months
The investigators will measure fasting plasma glucose levels in blood samples before and after treatment.
1 secondary outcome
Change in blood lipids from baseline
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2024.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Traditional deep-fried Youtiao and PI Youtiao in people with Metabolism and Nutrition Disorder, run by Yu Zhang.
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 8 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: status not confirmed, as of the sponsor's last update on 21 May 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yu Zhang, PHD (86-0571-88982211, yzhang@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HbA1c (time frame: 6 months). The study lists 2 primary outcomes in all. 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 21 May 2024.