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OpenTrials
Completed

NCT Number: NCT04651023

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.

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Key information

Conditions

Over Weight People

Age range

40 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nelumbo nucifera Leaf Extract

Dietary Supplement

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

Primary outcomes

  1. Changes in anthropometrix indices during the study

    Time frame: baseline, 6 weeks, 12 weeks

    weight in kilograms

  2. Changes in anthropometrix indices during the study

    Time frame: baseline, 6 weeks, 12 weeks

    height in meters

  3. Changes in anthropometrix indices during the study

    Time frame: baseline, 6 weeks, 12 weeks

    body fat in percentage

  4. Changes in anthropometrix indices during the study

    Time frame: baseline, 6 weeks, 12 weeks

    visceral fat in percentage

  5. Changes in anthropometrix indices during the study

    Time frame: baseline, 6 weeks, 12 weeks

    waist in centimeters

  6. Changes in anthropometrix indices during the study

    Time frame: baseline, 6 weeks, 12 weeks

    hip in centimeters

Secondary outcomes

  1. Changes in fasting biochemical indices during the study

    Time frame: baseline, 6 weeks, 12 weeks

    glucose in mmol/L

  2. Changes in fasting biochemical indices during the study

    Time frame: baseline, 6 weeks, 12 weeks

    HbA1c in mmol/L

  3. Changes in fasting biochemical indices during the study

    Time frame: baseline, 6 weeks, 12 weeks

    TG in mmol/L

  4. Changes in fasting biochemical indices during the study

    Time frame: baseline, 6 weeks, 12 weeks

    FFA in mmol/L

  5. Changes in fasting biochemical indices during the study

    Time frame: baseline, 6 weeks, 12 weeks

    T-cho in mmol/L

  6. Changes in fasting biochemical indices during the study

    Time frame: baseline, 6 weeks, 12 weeks

    HDL-cho in mmol/L

  7. Changes in fasting biochemical indices during the study

    Time frame: baseline, 6 weeks, 12 weeks

    LDL-cho in mmol/L

  8. Changes in fasting biochemical indices during the study

    Time frame: baseline, 6 weeks, 12 weeks

    ASP in mmol/L

  9. Changes in fasting biochemical indices during the study

    Time frame: baseline, 6 weeks, 12 weeks

    BUN in mmol/L

Sponsors and collaborators

Lead sponsor

Shanghai Meiji Health Science and Technology Co., Ltd.

Industry

Registry information

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Dec 3, 2020
Registry last updated
Dec 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.