None
Conditions
Interventions
Dietary Intervention Group 1:The first two weeks were a low-processed diet, and the following two weeks were an ultra-processed diet. There was no washout period.
Dietary Intervention Group 2:The first two weeks were of ultra-processed diet, and the next two weeks were of low-processed diet. There was no washout period.
Sponsors
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18 - 45 years old; 2. Body Mass Index (BMI) range: 18 kg/m^2 <= BMI < 30 kg/m^2; 3. Weight remained stable in the three months prior to the screening period (weight change in the past three months <= 5%); 4. Thoroughly understand the nature, significance, potential benefits, possible inconveniences and potential risks of the trial; able to follow the dietary plan stipulated in the study, without severe food allergies or dietary restrictions; understand the research procedures, voluntarily participate in this study and sign the informed consent form, and complete the visits and sample collection on time.
Exclusion criteria
Exclusion criteria: 1. Those with type 1 diabetes (T1DM), type 2 diabetes (T2DM), monogenic mutation diabetes, diabetes caused by pancreatic damage, or other secondary diabetes (such as diabetes caused by Cushing's syndrome, thyroid dysfunction, or acromegaly, etc.); 2. Those with other severe organic heart diseases, such as congenital heart disease, rheumatic heart disease, hypertrophic or dilated cardiomyopathy, chronic congestive heart failure (NYHA >= III grade), etc., or those who have received interventional therapy or used heart stents, or have refractory hypertension or grade III hypertension; 3. Those with hyperthyroidism or hypothyroidism; 4. Those who have had organ system tumors (except for local basal cell carcinoma of the skin) within the past 5 years, regardless of whether there is evidence of local recurrence or metastasis; 5. Those with a history of food allergy; 6. Those with gastrointestinal diseases that affect food digestion and absorption (such as severe diarrhea, constipation, irritable bowel syndrome, inflammatory bowel disease, active gastrointestinal ulcers, acute cholecystitis, etc.); severe diarrhea refers to three or more watery stools per day for 3 days or more, and severe constipation refers to less than 2 stools per week, accompanied by difficulty in defecation; 7. Those with any mental illness or history of mental illness; patients with epilepsy or those using antidepressants during antiepileptic treatment; 8. Those with any infectious disease history, such as hepatitis B, hepatitis C, tuberculosis, syphilis, AIDS, etc.; 9. Those with severe infection, severe anemia, neutropenia; 10. Those who have undergone major surgery within 1 year before the screening period (except for appendicitis and hernia surgery); 11. Those who have had intestinal resection history, or those who have had other digestive tract surgeries within 1 year before the screening (such as cholecystectomy), or those who have had other non-digestive tract surgeries within 6 months before the screening; 12. Those who have used oral hypoglycemic drugs, insulin, or incretin drugs to control diabetes; 13. Those who plan to use weight control drugs (including weight loss drugs), corticosteroids and other hormone drugs (including oral, intramuscular injection or intravenous systemic administration, non-digestive tract administration or intra-articular administration) during the screening period; 14. Those who frequently use antibiotics drugs within 1 month before the screening period, each use lasting for 3 days or more; 15. Those who have taken probiotics or prebiotics products within 1 month before the screening period; 16. Those with severe liver or kidney dysfunction, or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >= 2.5×ULN, serum creatinine > ULN, glomerular filtration rate (eGFR) < 60 mL/min/1.73m^2 (calculated using the MDRD formula) within the screening period; 17. Those who plan to use drugs (including traditional Chinese medicine, Chinese patent medicine) to intervene or change body weight during the study period; 18. Those with a history of substance abuse and/or alcoholism (men consuming more than 40 grams of alcohol per day, women consuming more than 20 grams of alcohol per day, 40 grams of alcohol is approximately 1000 mL of beer (6 degrees), or 500 mL of red wine or yellow wine (12 degrees), or 100 mL of white wine (50 degrees)); 19. Pregnant or lactating women; 20. Those with severe lactose intolerance; 21. Those who are cur
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Peripheral blood metabolomics, proteomics, and transcriptomics.;Metagenomic sequencing, transcriptomics, metabolomics, and proteomics of the gut microbiota.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Body composition indicators such as body fat and skeletal muscle mass.;Blood routine, urine routine, blood biochemistry;Blood lipid examination: TG?TC?LDL-C?HDL-C;Human energy metabolic chamber;Glucose metabolism related indicators:FPG; 2hPG; FINS; 2hINS; fasting GLP-1; 2h GLP-1; Insulin Sensitivity; CGM;Basic vital signs (blood pressure, respiratory rate, pulse, and body temperature) ; height, weight, BMI, and body circumferences (neck, waist, and hip circumference) ;; | — |
Countries
China
Contacts
Public ContactGuang Ning
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed