Metabolism and Nutrition DisorderNCT06686199
Potato Diet Intervention Study in a College Population
A study testing steamed potato and fried potato in people with Metabolism and Nutrition Disorder, run by Yu Zhang.
Trial summary
The goal of this study is to investigate the effects of a potato-based diet intervention on Chinese university students. Employing a randomized controlled double-blind trial design, the intervention will span 8 weeks. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolism and Nutrition Disorder
- What is being tested?
- steamed potato and fried potato
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 3 Mar 2025to 1 Jun 2025
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- University students at school
Who cannot join
- Smoking (≥1 cigarette/week);
- heavy alcohol consumption (>224 g/week for men and >168 g/week for women);
- diabetes, heart disease, stroke, high blood pressure, liver dysfunction, kidney dysfunction, or gastrointestinal disorders;
- taking dietary supplements (e.g., vitamins, minerals, probiotics, or prebiotics);
- taking medications (e.g., aspirin, statin, or antihypertensive medications);
- within the past 3 months taken antibiotics;
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- had surgery in the past 3 months;
- participated in other clinical studies in the past 3 months;
- preference for fried and baked foods.
Trial locations and contacts
No sites are listed yet.
About this study
The goal of this study is to investigate the effects of a potato-based diet intervention on Chinese university students. Employing a randomized controlled double-blind trial design, the intervention will span 8 weeks. The primary objectives include:
- Examining the impact of the potato-based diet intervention on the overall glucose and lipid metabolism levels of university students;
- Exploring the interactions between the potato-based diet intervention and individual metabolic profiles and glucose-lipid metabolic pathways;
- Analyzing the association between the potato-based diet intervention and gut health through gut microbiota analysis.
Participants will undergo either the potato-based diet intervention or the control group treatment. Changes in waist circumference, blood pressure, blood glucose, and blood lipid levels will be observed to assess the effects of the potato-based diet on university students' health. Additionally, alterations in metabolic profiles and glucose-lipid metabolic pathways will be analyzed, along with gut microbiota analysis, to investigate the relationship between the potato-based diet and gut health.
Read the detailed description
This study aims to recruit young adults aged 18-35 from university populations who meet the criteria and are willing to participate. After screening based on baseline information, eligible volunteers will be randomly assigned to two groups: an intervention group and a control group. The intervention group will consume fried potatoes, while the control group will consume steamed potatoes, at a daily dose of 135g, 4-5 times a week, for an 8-week dietary intervention period.
- The effects of potato-based dietary intervention on the metabolic profiles of glucose and lipids in the human body will be assessed. General indicators such as height, weight, blood pressure, waist circumference, and hip circumference will be measured at baseline and at the intervention endpoint for all participants. Fasting blood samples will be collected to measure four lipid parameters (TG, TC, LDL-C, HDL-C), fasting blood glucose, fasting insulin, glycosylated hemoglobin levels, and serum C-peptide levels. Changes and differences in glucose and lipid metabolism indicators among groups will be observed.
- The role of potato-based dietary intervention on the blood metabolic profiles, gut microbiota composition, and inflammatory response in university student populations will be investigated. Blood and stool samples will be collected to study the effects of potato-based dietary intervention on metabolic markers of glucose and lipids in biological samples and the gut microbiota composition in fecal samples. The analysis will focus on its effects on serum inflammatory factors by influencing glucose and lipid metabolism pathways and gut microbiota composition, as well as inflammatory signaling pathways, elucidating the mechanisms through which it modulates glucose and lipid metabolism.
- Conditions
- Metabolism and Nutrition Disorder
- Being tested
- steamed potato, fried potato
- Medical subject headings
- Nutrition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
steamed potatoDietary supplement
135 g per day 4-5 times per week for 8 weeks
fried potatoDietary supplement
135 g per day 4-5 times per week for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | Not described Receives: Dietary Supplement: steamed potato |
| Intervention group | Experimental | Not described Receives: Dietary Supplement: fried potato |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body weight from baseline
The investigators will measure body weight before and after treatment.
Measured: Time Frame: 2 months
Change in blood glucose from baseline
The investigators will measure fasting plasma glucose levels in blood samples before and after treatment.
Measured: Time Frame: 2 months
Change in triglycerides from baseline
The investigators will measure Triglyceride levels in blood samples before and after treatment.
Measured: 2 month
Secondary outcomes (1)
Change in lipid indicators from baseline
The investigators will measure total cholesterol, LDL-C, and HDL-C levels in blood samples before and after treatment.
Measured: 2 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2024
- Study start3 Mar 2025 (estimated)
- Primary completion1 May 2025 (estimated)
- Study completion1 Jun 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 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
- NCT06686199
- Sponsor's protocol ID
- RCT_ Potato Meal
- Status last verified
- Jul 2024
- First submitted
- 15 Jul 2024
- Last updated
- 13 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Potato Diet Intervention Study in a College Population
- ClinicalTrials.gov ID
- NCT06686199
- Acronym / sponsor ID
- RCT_ Potato Meal
- Conditions
- Metabolism and Nutrition Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Yu ZhangUniversity, hospital or other
- Study start
- 3 Mar 2025 (estimated)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 13 Nov 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 study is to investigate the effects of a potato-based diet intervention on Chinese university students. Employing a randomized controlled double-blind trial design, the intervention will span 8 weeks. The primary objectives include:
- Examining the impact of the potato-based diet intervention on the overall glucose and lipid metabolism levels of university students;
- Exploring the interactions between the potato-based diet intervention and individual metabolic profiles and glucose-lipid metabolic pathways;
- Analyzing the association between the potato-based diet intervention and gut health through gut microbiota analysis.
Participants will undergo either the potato-based diet intervention or the control group treatment. Changes in waist circumference, blood pressure, blood glucose, and blood lipid levels will be observed to assess the effects of the potato-based diet on university students' health. Additionally, alterations in metabolic profiles and glucose-lipid metabolic pathways will be analyzed, along with gut microbiota analysis, to investigate the relationship between the potato-based diet and gut health.
Detailed description
This study aims to recruit young adults aged 18-35 from university populations who meet the criteria and are willing to participate. After screening based on baseline information, eligible volunteers will be randomly assigned to two groups: an intervention group and a control group. The intervention group will consume fried potatoes, while the control group will consume steamed potatoes, at a daily dose of 135g, 4-5 times a week, for an 8-week dietary intervention period.
- The effects of potato-based dietary intervention on the metabolic profiles of glucose and lipids in the human body will be assessed. General indicators such as height, weight, blood pressure, waist circumference, and hip circumference will be measured at baseline and at the intervention endpoint for all participants. Fasting blood samples will be collected to measure four lipid parameters (TG, TC, LDL-C, HDL-C), fasting blood glucose, fasting insulin, glycosylated hemoglobin levels, and serum C-peptide levels. Changes and differences in glucose and lipid metabolism indicators among groups will be observed.
- The role of potato-based dietary intervention on the blood metabolic profiles, gut microbiota composition, and inflammatory response in university student populations will be investigated. Blood and stool samples will be collected to study the effects of potato-based dietary intervention on metabolic markers of glucose and lipids in biological samples and the gut microbiota composition in fecal samples. The analysis will focus on its effects on serum inflammatory factors by influencing glucose and lipid metabolism pathways and gut microbiota composition, as well as inflammatory signaling pathways, elucidating the mechanisms through which it modulates glucose and lipid metabolism.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Dietary Supplement: steamed potato |
| Intervention group | Experimental | Dietary Supplement: fried potato |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- University students at school
Key exclusion criteria (9 listed)
- Smoking (≥1 cigarette/week);
- heavy alcohol consumption (>224 g/week for men and >168 g/week for women);
- diabetes, heart disease, stroke, high blood pressure, liver dysfunction, kidney dysfunction, or gastrointestinal disorders;
- taking dietary supplements (e.g., vitamins, minerals, probiotics, or prebiotics);
- taking medications (e.g., aspirin, statin, or antihypertensive medications);
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 |
|---|---|---|
| steamed potato135 g per day 4-5 times per week for 8 weeks | Dietary supplement | Control group |
| fried potato135 g per day 4-5 times per week for 8 weeks | Dietary supplement | Intervention group |
Primary outcome
Change in body weight from baseline
Time frame: Time Frame: 2 months
The investigators will measure body weight before and after treatment.
Change in blood glucose from baseline
Time frame: Time Frame: 2 months
The investigators will measure fasting plasma glucose levels in blood samples before and after treatment.
Change in triglycerides from baseline
Time frame: 2 month
The investigators will measure Triglyceride levels in blood samples before and after treatment.
1 secondary outcome
Change in lipid indicators from baseline
Time frame: 2 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2024.
- Individual participant dataSharing planned: No
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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 study testing steamed potato and fried potato 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 1 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: status not confirmed, as of the sponsor's last update on 13 Nov 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.
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 (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 body weight from baseline (time frame: Time Frame: 2 months). The study lists 3 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 13 Nov 2024.