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NCT Number: NCT07533513

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sun Yat-sen University

Shenzhen, Guangdong, 518107, China

Location contact

Wenjing Liu

CONTACT

[email protected]

86+18315843961

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Diet

Other

Diet with high carbohydrate contents and high GI values.

Primary outcomes

  1. Glucose

    Time frame: 22-week period

  2. Lipids

    Time frame: 22-week period

Secondary outcomes

  1. Insulin

    Time frame: 22-week period

  2. LDL and HDL subfractions

    Time frame: 22-week period

  3. Gut microbiota

    Time frame: 22-week period

  4. Bile acid

    Time frame: 22-week period

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Apr 16, 2026
Registry last updated
Apr 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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