Obesity/overweight
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female between the ages of 18 and 65; 2. 24.0kg/?=BMI=34.9 kg/?; or waist circumference = 90 cm for men and 85 cm for women= 3. Agree to follow dietary and exercise guidelines during the study; 4. Willing to complete questionnaires, records and diaries related to the study, complete all 3 outpatient visits, and provide blood, feces, urine samples; 5. Provide voluntary, written, informed consent to participate in the research.
Exclusion criteria
Exclusion criteria: 1. The female was pregnant, nursing, or wishing to become pregnant during the study; 2. Taking drugs that may affect weight change within three months or during the trial (new), including anti-diabetic drugs, second-generation antipsychotics, hormonal drugs, antihistamines, a/ß blockers, diuretics, etc.; 3. Excessive use of dietary supplements, such as vitamin D >5000 IU/d, fish oil/omega-3>2 g/d; 4. Received bariatric surgery or slimming treatment such as Chinese herbal medicine, Chinese medicine acupuncture, thread burial, tuina, acupoint thread burial, electroacupuncture stimulation, cupping, gua sha, Chinese medicine acupoint application and other weight loss treatment within three months; 5. Taking probiotics (including yogurt containing probiotics) or antibiotics within one month, and not using antibiotics or other probiotic-containing products during the trial; 6. History of cancer, cardiovascular, digestive diseases (IBD, IBS), autoimmune diseases; 7. Weight change of more than 5 kg within three months; 8. Participation in other clinical research trials 30 days prior to screening; 9. High alcohol intake (male > 25g/d, female >15g/d) intake (calculation formula: alcohol consumption ml× alcohol concentration (%) × 0.8); 10. Use of tobacco products during the trial (smoking index (SI) >200, calculated as: SI = number of cigarettes smoked× age smoked); 11. Hypersensitivity, sensitivity or intolerance to the active or inactive ingredient of the study product; 12. Incapacitated or vulnerable groups.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Body fat changes;Glycated hemoglobin; | — |
Secondary
| Measure | Time frame |
|---|---|
| Android/gynoid fat ratio;Fat mass;BMI;waistline;Hip circumference;Fractionation of nonalcoholic fatty liver disease;blood lipids;Serum low-grade inflammation profile;Body composition;Fasting blood sugar;Fasting insulin; | — |
Countries
China
Contacts
The Second Affiliated Hospital of Zhejiang University of Traditional Chinese Medicine