Shanghai Meiji Health Science and Technology Co., Ltd

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04651023

Enrollment

Registered

2020-12-03

Start date

2009-01-10

Completion date

2009-06-20

Last updated

2020-12-03

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

Conditions

Over Weight People

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.

Interventions

DIETARY_SUPPLEMENTNelumbo nucifera Leaf Extract

Hot water extracted Nelumbo nucifera Leaf, mainly containing quercetin and quercetin 3-O-glucuronide.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

ALL

Age

40 Years to 60 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Changes in anthropometrix indices during the study	baseline, 6 weeks, 12 weeks	weight in kilograms

Secondary

Measure	Time frame	Description
Changes in fasting biochemical indices during the study	baseline, 6 weeks, 12 weeks	glucose in mmol/L

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026