Shanghai Meiji Health Science and Technology Co., Ltd

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.

Study Overview

• Status: Completed
• Conditions: Over Weight People
• Intervention / Treatment: Dietary supplement: Nelumbo nucifera Leaf Extract

• Study Type: Interventional
• Enrollment (Actual): 95
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: control group; 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; Hot water extracted Nelumbo nucifera Leaf, mainly containing quercetin and quercetin 3-O-glucuronide.
Experimental: low concentration of NnEx group; 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; Hot water extracted Nelumbo nucifera Leaf, mainly containing quercetin and quercetin 3-O-glucuronide.
Experimental: high concentration of NnEx group; 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; Hot water extracted Nelumbo nucifera Leaf, mainly containing quercetin and quercetin 3-O-glucuronide.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Shanghai Meiji Health Science and Technology Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2009
• Primary Completion (Actual): May 15, 2009
• Study Completion (Actual): June 20, 2009

Study Registration Dates

• First Submitted: November 16, 2020
• First Submitted That Met QC Criteria: November 25, 2020
• First Posted (Actual): December 3, 2020

Study Record Updates

• Last Update Posted (Actual): December 3, 2020
• Last Update Submitted That Met QC Criteria: November 25, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Overweight
• Other Study ID Numbers: ShanghaiMHST

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No