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Study on the role of personalized health food intervention for nutritional chronic diseases based on clinical multi-omics

Study on the role of personalized health food intervention for nutritional chronic diseases based on clinical multi-omics

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400089658
Enrollment
Unknown
Registered
2024-09-12
Start date
2022-10-28
Completion date
Unknown
Last updated
2024-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, NAFLD and Hyperglycemia

Interventions

Moringa Polyphenols Group :1 solid drink containing 2 g of moringa polyphenols in the morning and 1 solid drink in the evening for 3 months, during which a dietary healthy lifestyle intervention was c
Moringa Polyphenols Placebo Group:1 sachet of a placebo solid drink without moringa polyphenols and the rest of the same composition in the morning and evening for 3 months, during which a dietary hea
Pheomelanin Group:Administration of Pu-erh tea extract 2.7g/day (with >60% theaflavins) for 3 months of intervention
Theaflavin Placebo Group:Equivalent placebo (beta dextrin with caramel coloring) similar in appearance to teosinte taken daily for 3 months of intervention
Conjugated linoleic acid Group:160ml of fermented milk rich in conjugated linoleic acid per day
Conjugated linoleic acid placebo group:Drinking the same dose of zero-added fermented milk every day

Sponsors

Kunming Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Moringa polyphenol intervention trial: (1) BMI = 28kg/m^2, (2) no other chronic diseases, (3) understand the research steps and be willing to participate in the study. Theabrownin intervention trial: (1) age between 40~70 years old, (2) hyperglycemia patients: fasting blood glucose higher than 6.1mmol/L or 2-hour postprandial blood glucose higher than 7.8mmol/L. Non-alcoholic fatty liver intervention trial: 1) both men and women, aged 18-65 years old, (2) no history of alcohol consumption in the past three months or alcohol equivalent to alcohol < 140g per week for men and 70g <per week for women, (3) mild to moderate non-alcoholic fatty liver disease, (4) willing to receive at least 12 weeks of dietary intervention and health behavior intervention with fermented milk rich in conjugated linoleic acid, (5) strictly follow the experimental procedures.

Exclusion criteria

Exclusion criteria: Moringa polyphenol intervention trial: (1) unwilling to accept informed consent, (2) have other chronic diseases other than obesity, and (3) have participated in other clinical studies within 30 days. Theabrownin intervention trial: (1) severe cardiovascular and cerebrovascular diseases, severe kidney diseases, malignant tumors, etc., (2) participation in other clinical studies within 30 days, (3) cases that may affect clinical evaluation in the opinion of the competent doctor, or cases that are not suitable for clinical research. Non-alcoholic fatty liver disease intervention trial: (1) unwilling to accept informed consent, (2) participated in other clinical studies within 30 days, and (3) could not strictly follow the experimental procedures.

Design outcomes

Primary

MeasureTime frame
body composition;Metabolomics;microbial diversity;Hypoglycemia;Glycosylated hemoglobin;Fasting insulin;Abdominal ultrasound;Lipid Indicators;

Secondary

MeasureTime frame
Liver and kidney function;Inflammatory factor;

Countries

China

Contacts

Public ContactWu Shaoxiong

Kunming Medical University

806535034@qq.com+86 138 8898 9857

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026