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Human study on the effect of reducing body fat with Yili self-owned intellectual property rights probiotic K56 product prototype

Effect of a probiotic strain Lactobacillus paracasei K56 on metabolic symptom - a pilot study

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100048941
Enrollment
Unknown
Registered
2021-07-19
Start date
2021-01-10
Completion date
Unknown
Last updated
2022-03-28

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

Conditions

obesity (defined by PBF)

Interventions

K56 very high dose -E1:Probiotic drink (K56 10^12CFU) 350ml/d
control -E2:maltodextrin powder 3g/d
K56 high dose-E3:Probiotic powder 3.0g/d (K56 10^10cfu)
K56 middle dose-E5:Probiotic powder 8.0g/d (K56 10^9cfu)
K56 low dose -E7:probiotic k56 capsule, 2capsules/d (10^7cfu/day)
K56 middle dose-E9:probiotic k56 capsule, 2capsules/d (10^9cfu)
K56 high dose-E10:probiotic k56 capsule, 2capsules/d (10^10cfu)
K56 very high dose-E11:probiotic k56 capsule, 4capsules/d (10^11cfu)

Sponsors

Shanghai Hua Dong Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
22 Years to 59 Years

Inclusion criteria

Inclusion criteria: 1. BMI>=30kg/m2,or percent of body fat(PBF) >=25% for male, >=30 for female. 2. Aged 18 - 60 years old adults

Exclusion criteria

Exclusion criteria: 1.patiants with severe chronic diseases (coronary heart disease, diabetes, hypertension, immune deficiency, mental disorders, tumors, liver and kidney dysfunction, etc.) and complications;irritable bowel syndrome; 2.History of intervention with fat-reducing drugs or health products in the past 2 months; 3.take weight control measures (diet, exercise, etc.) within the past month; 4.Those who cannot guarantee to maintain their current lifestyle during the trial period; 5.Those who fail to consume the tested samples as required, or fail to follow up on time, resulting in failure to determine the efficacy.

Design outcomes

Primary

MeasureTime frame
body composition (PBF,VFA,etc);

Secondary

MeasureTime frame
metaboolic indicators;Life style(diet,exercise,etc.);The recognition of TCM constitution;

Countries

China

Contacts

Public ContactFeng Ying

Shanghai Hua Dong Hospital

yingfenghd@hotmail.com+86 18121221972

Outcome results

None listed

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