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Not yet recruiting NCT07533513

Effects and Mechanisms of Dietary Carbohydrate Intake and Quality on Glucose and Lipid Metabolism

No phase Interventional Metabolic Syndrome (MetS) Metabolic Syndrome Risk Factors

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Diet, Diet, Diet, Diet.
Who it may be relevant to
Registry conditions: Metabolic Syndrome (MetS), Metabolic Syndrome Risk Factors. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

  • Other Diet
    Diet with high carbohydrate contents and high GI values.
  • Other Diet
    Diet with high carbohydrate contents and low GI values.
  • Other Diet
    Diet with low carbohydrate contents and high GI values.
  • Other Diet
    Diet with low carbohydrate contents and low GI values.

Primary outcome measures

  • Glucose [Time frame: 22-week period]
  • Lipids [Time frame: 22-week period]
Secondary outcome measures (4)
  • 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]

Eligibility criteria

Inclusion criteria

  • 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).

Exclusion criteria

  • 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;
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Double blind
Primary purpose
Basic science

Study locations

China · 1 center
  • Sun Yat-sen University — Shenzhen

Identifiers

NCT: NCT07533513 · SYSU PH (SZ) ME [2026] 043

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗