Shanghai Meiji Health Science and Technology Co., Ltd

NCT04651023 | Completed

• 1 other identifier: ShanghaiMHST
• Study Type: interventional
• Target: 95
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Over Weight People

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (9)

• Changes in fasting biochemical indices during the study

  baseline, 6 weeks, 12 weeks

• Changes in fasting biochemical indices during the study

  baseline, 6 weeks, 12 weeks

• Changes in fasting biochemical indices during the study

  baseline, 6 weeks, 12 weeks

• Changes in fasting biochemical indices during the study

  baseline, 6 weeks, 12 weeks

• Changes in fasting biochemical indices during the study

  baseline, 6 weeks, 12 weeks

Study Arms (3)

control group

PLACEBO COMPARATOR

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

low concentration of NnEx group

EXPERIMENTAL

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

high concentration of NnEx group

EXPERIMENTAL

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

Interventions

Nelumbo nucifera Leaf Extract DIETARY_SUPPLEMENT

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

control group; high concentration of NnEx group; low concentration of NnEx group

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 16, 2020
• First Posted: December 3, 2020
• Study Start: January 10, 2009
• Primary Completion: May 15, 2009
• Study Completion: June 20, 2009
• Last Updated: December 3, 2020

Record last verified: 2020-11