Shanghai Meiji Health Science and Technology Co., Ltd
Not Applicable
Completed
- Conditions
- Over Weight People
- Registration Number
- NCT04651023
- Brief Summary
Investigators performed a randomized double-blind trial to determine the effects of long-term NnEx ingestion in patients with overweight or obesity. Ninety-five participants (23\<BMI\<30 kg/m2) were randomly allocated to three groups: a control group, a 1 g/day NnEx group, and a 2 g/day NnEx group. The effects of the consumption of 2 g/day or 1 g/day NnEx for 12 weeks on indices of adiposity and fasting blood metabolic parameters were compared with those of no consumption of NnEx.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 95
Inclusion Criteria
- Has a body mass index (BMI) of 23-30 kg/m2
- Has no history of using any antidiabetic medication
- Absence of liver, kidney, or heart disease
- Absence of food allergy and daily tea consumption <2 L
- Meet all of the above criteria and to follow the instructions given during the study.
Exclusion Criteria
- Testing delayed for >1 week without justification
- Difficulty attending the hospital on the required days
- Lack of data regarding the times of beverage consumption for over 5% of the study
- Abnormal overeating
- Test results believed to be unreliable because of the lack of provision of diet and exercise reports during the fasting period
- Difficulty drawing blood
- Poor confidence in the test data
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Changes in anthropometrix indices during the study baseline, 6 weeks, 12 weeks hip in centimeters
- Secondary Outcome Measures
Name Time Method Changes in fasting biochemical indices during the study baseline, 6 weeks, 12 weeks BUN in mmol/L
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular pathways does Nelumbo nucifera Leaf Extract (NnEx) modulate to reduce adiposity in overweight individuals?
How does the efficacy of 1g/day and 2g/day NnEx compare to standard-of-care weight management interventions in patients with BMI 23-30 kg/m²?
Which biomarkers correlate with metabolic response to Nelumbo nucifera Leaf Extract in clinical trials for obesity?
What are the long-term safety profiles and adverse event management strategies for Nelumbo nucifera Leaf Extract ingestion in obese populations?
Are there synergistic combination therapies involving NnEx and other anti-obesity agents studied by Shanghai Meiji Health Science and Technology Co., Ltd?