Shanghai Meiji Health Science and Technology Co., Ltd

Study Overview
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Brief Summary
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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.

Conditions
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Over Weight People

Intervention / Treatment
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* Dietary Supplement: Nelumbo nucifera Leaf Extract


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: control group<br>During the 12-week study period, the participants consumed two bottles (2 *200 mL) of the experimental beverage (0g NnEx) per day with or after meals. | Dietary Supplement: Nelumbo nucifera Leaf Extract<br>* Hot water extracted Nelumbo nucifera Leaf, mainly containing quercetin and quercetin 3-O-glucuronide.<br>|
| Experimental: low concentration of NnEx group<br>During the 12-week study period, the participants consumed two bottles (2 *200 mL) of the experimental beverage (1g NnEx) per day with or after meals. | Dietary Supplement: Nelumbo nucifera Leaf Extract<br>* Hot water extracted Nelumbo nucifera Leaf, mainly containing quercetin and quercetin 3-O-glucuronide.<br>|
| Experimental: high concentration of NnEx group<br>During the 12-week study period, the participants consumed two bottles (2 *200 mL) of the experimental beverage (2g NnEx) per day with or after meals. | Dietary Supplement: Nelumbo nucifera Leaf Extract<br>* Hot water extracted Nelumbo nucifera Leaf, mainly containing quercetin and quercetin 3-O-glucuronide.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in anthropometrix indices during the study | weight in kilograms | baseline, 6 weeks, 12 weeks | 
| Changes in anthropometrix indices during the study | height in meters | baseline, 6 weeks, 12 weeks | 
| Changes in anthropometrix indices during the study | body fat in percentage | baseline, 6 weeks, 12 weeks | 
| Changes in anthropometrix indices during the study | visceral fat in percentage | baseline, 6 weeks, 12 weeks | 
| Changes in anthropometrix indices during the study | waist in centimeters | baseline, 6 weeks, 12 weeks | 
| Changes in anthropometrix indices during the study | hip in centimeters | baseline, 6 weeks, 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in fasting biochemical indices during the study | glucose in mmol/L | baseline, 6 weeks, 12 weeks | 
| Changes in fasting biochemical indices during the study | HbA1c in mmol/L | baseline, 6 weeks, 12 weeks | 
| Changes in fasting biochemical indices during the study | TG in mmol/L | baseline, 6 weeks, 12 weeks | 
| Changes in fasting biochemical indices during the study | FFA in mmol/L | baseline, 6 weeks, 12 weeks | 
| Changes in fasting biochemical indices during the study | T-cho in mmol/L | baseline, 6 weeks, 12 weeks | 
| Changes in fasting biochemical indices during the study | HDL-cho in mmol/L | baseline, 6 weeks, 12 weeks | 
| Changes in fasting biochemical indices during the study | LDL-cho in mmol/L | baseline, 6 weeks, 12 weeks | 
| Changes in fasting biochemical indices during the study | ASP in mmol/L | baseline, 6 weeks, 12 weeks | 
| Changes in fasting biochemical indices during the study | BUN in mmol/L | baseline, 6 weeks, 12 weeks |