Metabolic Syndrome (MetS)NCT07533513
Effects and Mechanisms of Dietary Carbohydrate Intake and Quality on Glucose and Lipid Metabolism
A study testing Diet in people with Metabolic Syndrome (MetS) and Metabolic Syndrome Risk Factors, run by Sun Yat-sen University at 1 site in China.
Trial summary
This study aimed to explore the effects of quantity and quality of dietary carbohydrate intakes on glucose and lipid levels and metabolism, as well as gut microbiota by a randomized crossover controlled intervention trial. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome (MetS), Metabolic Syndrome Risk Factors
- What is being tested?
- Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 13 Apr 2026to 30 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female aged 18 - 65 years;
- BMI 20 - 35 kg/m2;
- Consent to be randomly assigned to an intervention or control group;
- Willingness to eat the food and beverages provided in the study;
- Patients with or at high risk of metabolic syndrome, and the diagnostic criteria of metabolic syndrome were based on the Chinese Guidelines for the Prevention and Treatment of diabetes (2024 edition).
Who cannot join
- Use of medications that affect blood glucose metabolism;
- Familial hyperlipidemia, or use of drugs that affect lipid metabolism;
- Long-term or current use of nonsteroidal anti-inflammatory drugs, antibiotics, antihistamines, or immunomodulatory drugs, and unable to stop taking these drugs within 72 h before the start of the study;
- Use of hormonal medications such as anticoagulants, anabolic steroids, and hydrocortisone;
- Have a history of serious illness, or are in the acute stage of cardiovascular, renal, thyroid, gastrointestinal, hepatobiliary, immunologic, respiratory, neurological, musculoskeletal, psychiatric, infectious, and malignant diseases, and are receiving treatment or use of related drugs;
- Self-reported weight gain or loss of more than 7 kg in the 6 months before enrollment;
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- Vegetarian;
- Have food allergies or other problems that may affect food intake;
- Unable to consume only the food and beverages provided in the study;
- Drink alcohol more than 2 times per day, more than 14 times per week, and unwillingness to stop drinking during the study;
- Participate in a weight-loss program;
- Unwillingness to maintain weight throughout the study;
- Females who have given birth within the past year, are pregnant or plan to become pregnant within 6 months, are breastfeeding;
- Intend to participate in other dietary intervention studies and drug use studies in the next 4 months;
- Poor venous blood access;
- Any other that the physician assessed as unsuitable for the trial conditions.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Sun Yat-sen University
Shenzhen, Guangdong, 518107
Wenjing Liu, 86+18315843961, liuwj87@mail2.sysu.edu.cn
About this study
This study aimed to explore the effects of quantity and quality of dietary carbohydrate intakes on glucose and lipid levels and metabolism, as well as gut microbiota by a randomized crossover controlled intervention trial.
- Being tested
- Diet
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DietOther
Diet with high carbohydrate contents and high GI values.
DietOther
Diet with high carbohydrate contents and low GI values.
DietOther
Diet with low carbohydrate contents and high GI values.
DietOther
Diet with low carbohydrate contents and low GI values.
| Study group | Role | What they receive |
|---|---|---|
| High-carbohydrate high-GI diet | Other | Not described Receives: Other: Diet |
| High-carbohydrate low-GI diet | Other | Not described Receives: Other: Diet |
| Low-carbohydrate high-GI diet | Other | Not described Receives: Other: Diet |
| Low-carbohydrate low-GI diet | Other | Not described Receives: Other: Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose
Measured: 22-week period
Lipids
Measured: 22-week period
Secondary outcomes (4)
Insulin
Measured: 22-week period
LDL and HDL subfractions
Measured: 22-week period
Gut microbiota
Measured: 22-week period
Bile acid
Measured: 22-week period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study start13 Apr 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic Syndrome (MetS)Studies of the same condition, open and under way.
- More trials run by Sun Yat-sen 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
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huicui Meng, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07533513
- Sponsor's protocol ID
- SYSU PH (SZ) ME [2026] 043
- Status last verified
- Mar 2026
- First submitted
- 9 Apr 2026
- Last updated
- 16 Apr 2026
- 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 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects and Mechanisms of Dietary Carbohydrate Intake and Quality on Glucose and Lipid Metabolism
- ClinicalTrials.gov ID
- NCT07533513
- Acronym / sponsor ID
- SYSU PH (SZ) ME [2026] 043
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 13 Apr 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Mar 2028 (estimated)
- First posted
- 16 Apr 2026 (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.
This study aimed to explore the effects of quantity and quality of dietary carbohydrate intakes on glucose and lipid levels and metabolism, as well as gut microbiota by a randomized crossover controlled intervention trial.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| High-carbohydrate high-GI diet | Other | Other: Diet |
| High-carbohydrate low-GI diet | Other | Other: Diet |
| Low-carbohydrate high-GI diet | Other | Other: Diet |
| Low-carbohydrate low-GI diet | Other | Other: Diet |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male and female aged 18 - 65 years;
- BMI 20 - 35 kg/m2;
- Consent to be randomly assigned to an intervention or control group;
- Willingness to eat the food and beverages provided in the study;
- Patients with or at high risk of metabolic syndrome, and the diagnostic criteria of metabolic syndrome were based on the Chinese Guidelines for the Prevention and Treatment of diabetes (2024 edition).
Key exclusion criteria (16 listed)
- Use of medications that affect blood glucose metabolism;
- Familial hyperlipidemia, or use of drugs that affect lipid metabolism;
- Long-term or current use of nonsteroidal anti-inflammatory drugs, antibiotics, antihistamines, or immunomodulatory drugs, and unable to stop taking these drugs within 72 h before the start of the study;
- Use of hormonal medications such as anticoagulants, anabolic steroids, and hydrocortisone;
- Have a history of serious illness, or are in the acute stage of cardiovascular, renal, thyroid, gastrointestinal, hepatobiliary, immunologic, respiratory, neurological, musculoskeletal, psychiatric, infectious, and malignant diseases, and are receiving treatment or use of related drugs;
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 |
|---|---|---|
| DietDiet with high carbohydrate contents and high GI values. | Other | High-carbohydrate high-GI diet |
| DietDiet with high carbohydrate contents and low GI values. | Other | High-carbohydrate low-GI diet |
| DietDiet with low carbohydrate contents and high GI values. | Other | Low-carbohydrate high-GI diet |
| DietDiet with low carbohydrate contents and low GI values. | Other | Low-carbohydrate low-GI diet |
Primary outcome
Glucose
Time frame: 22-week period
Lipids
Time frame: 22-week period
4 secondary outcomes
Insulin
Time frame: 22-week period
LDL and HDL subfractions
Time frame: 22-week period
Gut microbiota
Time frame: 22-week period
Bile acid
Time frame: 22-week period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet in people with Metabolic Syndrome (MetS) and Metabolic Syndrome Risk Factors, run by Sun Yat-sen 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 5 inclusion and 16 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: opening soon, as of the sponsor's last update on 16 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glucose (time frame: 22-week period). 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 16 Apr 2026.