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Effects of Legumes Consumption on Weight Reduction

Primary Purpose

Obese

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Legume enriched diet group
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obese focused on measuring legumes, obesity, body weight, adiponectin, 8-epi-PGF2α, insulin resistance

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Male and female volunteers between the ages of 20 to 70 years
  2. Body mass index (BMI) of 25 kg/m2 or higher (based on Asia-Pacific guideline)
  3. Volunteers who have agreed to participate in the study and provided a written content by him/herself

Exclusion Criteria:

  1. Those with type 2 diabetes, cardiovascular disease, psychiatric problems, thyroid disorders, liver or kidney disease
  2. Those under the use of any medications (antihypertensive, lipid-lowering, antiplatelet, antidiabetic, etc.).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Legume enriched diet group

    Usual diet group

    Arm Description

    Replacing 1/3 refined rice intake with legumes three times per day Vegetable intake at least six units (30-70 g/unit) per day for sufficient dietary fiber intake Regular 30-min walk after dinner each day

    Maintaining usual diet Vegetable intake at least six units (30-70 g/unit) per day for sufficient dietary fiber intake Regular 30-min walk after dinner each day

    Outcomes

    Primary Outcome Measures

    Changes of BMI
    Changes of weight in kilograms was assessed before and after the intervention. Changes of height in meters was assessed before and after the intervention. Weight and height were combined to report BMI in kg/m^2.
    Changes of Insulin Resistance (IR)
    Changes of fasting serum glucose in mmol/L was assessed before and after the intervention. Changes of fasting insulin in μIU/mL was assessed before and after the intervention. Fasting insulin and fasting glucose were combined to report IR using the following equation: homeostasis model assessment (HOMA)-IR=[fasting insulin (μIU/mL)×fasting glucose (mmol/L)] /22.5.
    Changes of lipid profiles
    Triglyceride in mg/dL was assessed before and after the intervention. Total-cholesterol in mg/dL was assessed before and after the intervention. HDL-cholesterol in mg/dL was assessed before and after the intervention. LDL-cholesterol was indirectly estimated using the friedewald formula: LDL-cholesterol= total-cholesterol-[HDL-cholesterol+(triglycerides/5)].
    Changes of serum high C-reactive
    Changes of serum high C-reactive in mg/L was assessed before and after the intervention.
    Changes of urinary 8-epi-PGF2α
    Changes of urinary 8-epi-PGF2α in pg/mg creatinine was assessed before and after the intervention.
    Changes of adiponectin
    Changes of adiponectin in ng/mL was assessed before and after the intervention.

    Secondary Outcome Measures

    Full Information

    First Posted
    May 6, 2020
    Last Updated
    January 19, 2021
    Sponsor
    Yonsei University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04392882
    Brief Title
    Effects of Legumes Consumption on Weight Reduction
    Official Title
    Effects of Legumes Consumption on Weight Reduction
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    March 1, 2011 (Actual)
    Primary Completion Date
    March 31, 2013 (Actual)
    Study Completion Date
    March 31, 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Yonsei University

    4. Oversight

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

    5. Study Description

    Brief Summary
    This is a 12-week, randomized nutritional intervention study to determine the effect of legumes consumption on body weight in obese subjects.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obese
    Keywords
    legumes, obesity, body weight, adiponectin, 8-epi-PGF2α, insulin resistance

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    400 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Legume enriched diet group
    Arm Type
    Experimental
    Arm Description
    Replacing 1/3 refined rice intake with legumes three times per day Vegetable intake at least six units (30-70 g/unit) per day for sufficient dietary fiber intake Regular 30-min walk after dinner each day
    Arm Title
    Usual diet group
    Arm Type
    No Intervention
    Arm Description
    Maintaining usual diet Vegetable intake at least six units (30-70 g/unit) per day for sufficient dietary fiber intake Regular 30-min walk after dinner each day
    Intervention Type
    Behavioral
    Intervention Name(s)
    Legume enriched diet group
    Intervention Description
    Replacing 1/3 refined rice intake with legumes three times per day Vegetable intake at least six units (30-70 g/unit) per day for sufficient dietary fiber intake Regular 30-min walk after dinner each day
    Primary Outcome Measure Information:
    Title
    Changes of BMI
    Description
    Changes of weight in kilograms was assessed before and after the intervention. Changes of height in meters was assessed before and after the intervention. Weight and height were combined to report BMI in kg/m^2.
    Time Frame
    12 weeks
    Title
    Changes of Insulin Resistance (IR)
    Description
    Changes of fasting serum glucose in mmol/L was assessed before and after the intervention. Changes of fasting insulin in μIU/mL was assessed before and after the intervention. Fasting insulin and fasting glucose were combined to report IR using the following equation: homeostasis model assessment (HOMA)-IR=[fasting insulin (μIU/mL)×fasting glucose (mmol/L)] /22.5.
    Time Frame
    12 weeks
    Title
    Changes of lipid profiles
    Description
    Triglyceride in mg/dL was assessed before and after the intervention. Total-cholesterol in mg/dL was assessed before and after the intervention. HDL-cholesterol in mg/dL was assessed before and after the intervention. LDL-cholesterol was indirectly estimated using the friedewald formula: LDL-cholesterol= total-cholesterol-[HDL-cholesterol+(triglycerides/5)].
    Time Frame
    12 weeks
    Title
    Changes of serum high C-reactive
    Description
    Changes of serum high C-reactive in mg/L was assessed before and after the intervention.
    Time Frame
    12 weeks
    Title
    Changes of urinary 8-epi-PGF2α
    Description
    Changes of urinary 8-epi-PGF2α in pg/mg creatinine was assessed before and after the intervention.
    Time Frame
    12 weeks
    Title
    Changes of adiponectin
    Description
    Changes of adiponectin in ng/mL was assessed before and after the intervention.
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Male and female volunteers between the ages of 20 to 70 years Body mass index (BMI) of 25 kg/m2 or higher (based on Asia-Pacific guideline) Volunteers who have agreed to participate in the study and provided a written content by him/herself Exclusion Criteria: Those with type 2 diabetes, cardiovascular disease, psychiatric problems, thyroid disorders, liver or kidney disease Those under the use of any medications (antihypertensive, lipid-lowering, antiplatelet, antidiabetic, etc.).

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Effects of Legumes Consumption on Weight Reduction

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