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
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
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.).
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
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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