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Shanghai Meiji Health Science and Technology Co., Ltd

Primary Purpose

Over Weight People

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Nelumbo nucifera Leaf Extract
Sponsored by
Shanghai Meiji Health Science and Technology Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Over Weight People

Eligibility Criteria

40 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Placebo Comparator

    Experimental

    Experimental

    Arm Label

    control group

    low concentration of NnEx group

    high concentration of NnEx group

    Arm Description

    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.

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Changes in anthropometrix indices during the study
    weight in kilograms
    Changes in anthropometrix indices during the study
    height in meters
    Changes in anthropometrix indices during the study
    body fat in percentage
    Changes in anthropometrix indices during the study
    visceral fat in percentage
    Changes in anthropometrix indices during the study
    waist in centimeters
    Changes in anthropometrix indices during the study
    hip in centimeters

    Secondary Outcome Measures

    Changes in fasting biochemical indices during the study
    glucose in mmol/L
    Changes in fasting biochemical indices during the study
    HbA1c in mmol/L
    Changes in fasting biochemical indices during the study
    TG in mmol/L
    Changes in fasting biochemical indices during the study
    FFA in mmol/L
    Changes in fasting biochemical indices during the study
    T-cho in mmol/L
    Changes in fasting biochemical indices during the study
    HDL-cho in mmol/L
    Changes in fasting biochemical indices during the study
    LDL-cho in mmol/L
    Changes in fasting biochemical indices during the study
    ASP in mmol/L
    Changes in fasting biochemical indices during the study
    BUN in mmol/L

    Full Information

    First Posted
    November 16, 2020
    Last Updated
    November 25, 2020
    Sponsor
    Shanghai Meiji Health Science and Technology Co., Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04651023
    Brief Title
    Shanghai Meiji Health Science and Technology Co., Ltd
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    January 10, 2009 (Actual)
    Primary Completion Date
    May 15, 2009 (Actual)
    Study Completion Date
    June 20, 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Shanghai Meiji Health Science and Technology Co., Ltd.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Over Weight People

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare Provider
    Allocation
    Randomized
    Enrollment
    95 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    control group
    Arm Type
    Placebo Comparator
    Arm Description
    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.
    Arm Title
    low concentration of NnEx group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    high concentration of NnEx group
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Nelumbo nucifera Leaf Extract
    Intervention Description
    Hot water extracted Nelumbo nucifera Leaf, mainly containing quercetin and quercetin 3-O-glucuronide.
    Primary Outcome Measure Information:
    Title
    Changes in anthropometrix indices during the study
    Description
    weight in kilograms
    Time Frame
    baseline, 6 weeks, 12 weeks
    Title
    Changes in anthropometrix indices during the study
    Description
    height in meters
    Time Frame
    baseline, 6 weeks, 12 weeks
    Title
    Changes in anthropometrix indices during the study
    Description
    body fat in percentage
    Time Frame
    baseline, 6 weeks, 12 weeks
    Title
    Changes in anthropometrix indices during the study
    Description
    visceral fat in percentage
    Time Frame
    baseline, 6 weeks, 12 weeks
    Title
    Changes in anthropometrix indices during the study
    Description
    waist in centimeters
    Time Frame
    baseline, 6 weeks, 12 weeks
    Title
    Changes in anthropometrix indices during the study
    Description
    hip in centimeters
    Time Frame
    baseline, 6 weeks, 12 weeks
    Secondary Outcome Measure Information:
    Title
    Changes in fasting biochemical indices during the study
    Description
    glucose in mmol/L
    Time Frame
    baseline, 6 weeks, 12 weeks
    Title
    Changes in fasting biochemical indices during the study
    Description
    HbA1c in mmol/L
    Time Frame
    baseline, 6 weeks, 12 weeks
    Title
    Changes in fasting biochemical indices during the study
    Description
    TG in mmol/L
    Time Frame
    baseline, 6 weeks, 12 weeks
    Title
    Changes in fasting biochemical indices during the study
    Description
    FFA in mmol/L
    Time Frame
    baseline, 6 weeks, 12 weeks
    Title
    Changes in fasting biochemical indices during the study
    Description
    T-cho in mmol/L
    Time Frame
    baseline, 6 weeks, 12 weeks
    Title
    Changes in fasting biochemical indices during the study
    Description
    HDL-cho in mmol/L
    Time Frame
    baseline, 6 weeks, 12 weeks
    Title
    Changes in fasting biochemical indices during the study
    Description
    LDL-cho in mmol/L
    Time Frame
    baseline, 6 weeks, 12 weeks
    Title
    Changes in fasting biochemical indices during the study
    Description
    ASP in mmol/L
    Time Frame
    baseline, 6 weeks, 12 weeks
    Title
    Changes in fasting biochemical indices during the study
    Description
    BUN in mmol/L
    Time Frame
    baseline, 6 weeks, 12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Learn more about this trial

    Shanghai Meiji Health Science and Technology Co., Ltd

    We'll reach out to this number within 24 hrs