NCT07533513

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
24mo left

Started Apr 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress1%
Apr 2026Mar 2028

First Submitted

Initial submission to the registry

April 9, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

April 13, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 16, 2026

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2028

Last Updated

April 16, 2026

Status Verified

March 1, 2026

Enrollment Period

1.2 years

First QC Date

April 9, 2026

Last Update Submit

April 9, 2026

Conditions

Metabolic Syndrome (MetS)Metabolic Syndrome Risk Factors

Outcome Measures

Primary Outcomes (2)

  • Glucose

    22-week period

  • Lipids

    22-week period

Secondary Outcomes (4)

  • Insulin

    22-week period

  • LDL and HDL subfractions

    22-week period

  • Gut microbiota

    22-week period

  • Bile acid

    22-week period

Study Arms (4)

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

Interventions

DietOTHER

Diet with high carbohydrate contents and high GI values.

High-carbohydrate high-GI diet

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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;
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat-sen University

Shenzhen, Guangdong, 518107, China

Location

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

Diet

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 9, 2026

First Posted

April 16, 2026

Study Start

April 13, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

March 30, 2028

Last Updated

April 16, 2026

Record last verified: 2026-03

Locations

CN(1)