Shanghai Meiji Health Science and Technology Co., Ltd

Over Weight People Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04651023
• Other study ID #: ShanghaiMHST
• Status: Completed
• Phase: N/A
• Start date: January 10, 2009
• Est. completion date: June 20, 2009

Study information

• Verified date: November 2020
• Source: Shanghai Meiji Health Science and Technology Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: June 20, 2009
• Est. primary completion date: May 15, 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Over Weight People
• Overweight

Intervention

Dietary Supplement:
• Nelumbo nucifera Leaf Extract
Hot water extracted Nelumbo nucifera Leaf, mainly containing quercetin and quercetin 3-O-glucuronide.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Meiji Health Science and Technology Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in anthropometrix indices during the study	weight in kilograms	baseline, 6 weeks, 12 weeks
Primary	Changes in anthropometrix indices during the study	height in meters	baseline, 6 weeks, 12 weeks
Primary	Changes in anthropometrix indices during the study	body fat in percentage	baseline, 6 weeks, 12 weeks
Primary	Changes in anthropometrix indices during the study	visceral fat in percentage	baseline, 6 weeks, 12 weeks
Primary	Changes in anthropometrix indices during the study	waist in centimeters	baseline, 6 weeks, 12 weeks
Primary	Changes in anthropometrix indices during the study	hip in centimeters	baseline, 6 weeks, 12 weeks
Secondary	Changes in fasting biochemical indices during the study	glucose in mmol/L	baseline, 6 weeks, 12 weeks
Secondary	Changes in fasting biochemical indices during the study	HbA1c in mmol/L	baseline, 6 weeks, 12 weeks
Secondary	Changes in fasting biochemical indices during the study	TG in mmol/L	baseline, 6 weeks, 12 weeks
Secondary	Changes in fasting biochemical indices during the study	FFA in mmol/L	baseline, 6 weeks, 12 weeks
Secondary	Changes in fasting biochemical indices during the study	T-cho in mmol/L	baseline, 6 weeks, 12 weeks
Secondary	Changes in fasting biochemical indices during the study	HDL-cho in mmol/L	baseline, 6 weeks, 12 weeks
Secondary	Changes in fasting biochemical indices during the study	LDL-cho in mmol/L	baseline, 6 weeks, 12 weeks
Secondary	Changes in fasting biochemical indices during the study	ASP in mmol/L	baseline, 6 weeks, 12 weeks
Secondary	Changes in fasting biochemical indices during the study	BUN in mmol/L	baseline, 6 weeks, 12 weeks