Impaired Glucose Regulation (IGR) and overweight or obesity
Conditions
Interventions
Impaired glucose regulation but without overweight or obesity group:Thirty cases in the control group took the placebo
thirty cases in the test group took D-allulose
Overweight/obesity combined with impaired glucose regulation group:Thirty cases in the control group took the placebo
Non-overweight/non-obese and non-impaired glucose regulation group:Thirty cases in the control group took the placebo
Overweight/obese without impaired glucose regulation group:Thirty cases in the control group took the placebo
Sponsors
West China Fourth Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. General Inclusion Criteria (1) Aged 18 to 65 years, regardless of gender; (2) Not taking any other medications or functional foods that affect blood glucose, body weight, or glucose and lipid metabolism; (3) Voluntarily signed the informed consent form and able to cooperate in completing the entire intervention and all examinations. 2. Subgroup Inclusion Criteria A total of 240 subjects will be enrolled in this trial and divided into 4 subgroups, with 60 subjects in each group. (1) IGR (Impaired Glucose Regulation) criteria: Fasting Blood Glucose (FBG) 5.6~7.0 mmol/L (100~126 mg/dL) or 2-hour Postprandial Blood Glucose (2hPBG) 7.8~11.1 mmol/L (140~200 mg/dL). (2) Overweight/obesity criteria (meeting any one of the following): Body Mass Index (BMI) >=24 kg/m^2; excessive body fat percentage (male >25%, female >30%); central obesity defined as waist circumference >=85 cm (male) and >=80 cm (female); waist-to-hip ratio >=0.90 (male) and >=0.85 (female). 2.1 Normoglycemic and normal weight population (non-IGR and non-overweight/obese): 1) Fasting Blood Glucose (FBG) 3.9~5.5 mmol/L (100 mg/dL) and 2-hour Postprandial Blood Glucose (2hPBG) <7.8 mmol/L (140 mg/dL). 2) Body Mass Index (BMI) 18.5~23.9 kg/m^2, with waist circumference <85 cm and waist-to-hip ratio <0.90 (male); waist circumference <80 cm and waist-to-hip ratio <0.85 (female). 2.2 Overweight/obese but non-IGR population: 1) Fasting Blood Glucose (FBG) 3.9~5.5 mmol/L (100 mg/dL) and 2-hour Postprandial Blood Glucose (2hPBG) <7.8 mmol/L (140 mg/dL). 2) Meeting criterion (2). 2.3 IGR combined with overweight/obesity population: 1) Meeting both criteria (1) and (2). 2.4 IGR but non-overweight/obese population: 1) Body Mass Index (BMI) 18.5~23.9 kg/m^2, with waist circumference <85 cm and waist-to-hip ratio <0.90 (male); waist circumference <80 cm and waist-to-hip ratio <0.85 (female). 2) Meeting criterion (1).
Exclusion criteria
Exclusion criteria: 1. Patients With Confirmed Diabetes Mellitus; 2. Patients With Secondary Overweight/Obesity, Including That Caused By Diseases Such As Hypothyroidism And Cushing's Syndrome; 3. Patients With Severe Complications Of Major Organs (Heart, Liver, Kidney, Etc.), Or Those Complicated With Other Severe Physical Diseases Or Mental Disorders; 4. Patients With Intestinal Diseases Such As Inflammatory Bowel Disease, Or Those Who Have Taken Probiotics Or Antibiotics For A Long Time; 5. Individuals With Clinically Significant Abnormal Findings In Baseline Examinations Including Blood Routine, Urine Routine, Liver And Kidney Function, And Electrocardiogram (ECG); 6. Pregnant Or Lactating Women, And Individuals Allergic To Any Component Of The Test Sample; 7. Individuals With A History Of Infection, Surgery, Or Acute Metabolic Disorders Within The Past 3 Months; 8. Individuals Participating In Other Clinical Trials, Or Taking Substances Related To The Function Of Allulose That May Interfere With Result Interpretation; 9. Individuals Who Cannot Comply With Diet And Exercise Control, Or Fail To Consume The Test Sample As Prescribed, With Poor Compliance That May Affect Result Interpretation;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mitochondrial energy metabolism;Body Composition Analysis;Glycated Hemoglobin;Epigenetic information;blood glucose level;gut microbiota;Determination of related inflammatory and hormonal factors;blood lipid; | — |
Secondary
| Measure | Time frame |
|---|---|
| Routine blood, urine and stool tests;Blood Uric Acid, Urine Ketone Bodies;Liver and kidney function tests;Chest X-ray, Electrocardiogram, Abdominal B-ultrasound;Blood Uric Acid, Urine Ketone Bodies;Thyroid function, cortisol; | — |
Countries
China
Contacts
Public ContactChen Jinyao
West China Fourth Hospital of Sichuan University
Outcome results
None listed