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.

Study Overview

• Status: Not yet recruiting
• Conditions: Metabolic Syndrome Risk Factors; Metabolic Syndrome (MetS)
• Intervention / Treatment: Other: Diet; Other: Diet; Other: Diet; Other: Diet

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Shenzhen, Guangdong, China, 518107
      • Sun Yat-sen University
      • Contact: Wenjing Liu; Phone Number: 86+18315843961; Email: liuwj87@mail2.sysu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: High-carbohydrate high-GI diet	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.
Other: High-carbohydrate low-GI diet	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.
Other: Low-carbohydrate high-GI diet	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.
Other: Low-carbohydrate low-GI diet	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Glucose	22-week period
Lipids	22-week period

Secondary Outcome Measures

Outcome Measure	Time Frame
Insulin	22-week period
LDL and HDL subfractions	22-week period
Gut microbiota	22-week period
Bile acid	22-week period

Collaborators and Investigators

• Sponsor: Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Estimated): April 13, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): March 30, 2028

Study Registration Dates

• First Submitted: April 9, 2026
• First Submitted That Met QC Criteria: April 9, 2026
• First Posted (Actual): April 16, 2026

Study Record Updates

• Last Update Posted (Actual): April 16, 2026
• Last Update Submitted That Met QC Criteria: April 9, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Glucose Metabolism Disorders; Insulin Resistance; Hyperinsulinism; Nutritional and Metabolic Diseases; Metabolic Syndrome; Diet, Food, and Nutrition; Physiological Phenomena; Nutritional Physiological Phenomena; Diet
• Other Study ID Numbers: SYSU PH (SZ) ME [2026] 043

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No