Effects of Legumes Consumption on Weight Reduction

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

Official Title
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Effects of Legumes Consumption on Weight Reduction

Conditions
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Obese

Intervention / Treatment
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* Behavioral: Legume enriched diet group


Participation Criteria
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Eligibility Criteria
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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.).

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Legume enriched diet group<br>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 | Behavioral: Legume enriched diet group<br>* 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<br>|
| No Intervention: Usual diet group<br>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 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 weeks | 
| 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. | 12 weeks | 
| 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)]. | 12 weeks | 
| Changes of serum high C-reactive | Changes of serum high C-reactive in mg/L was assessed before and after the intervention. | 12 weeks | 
| Changes of urinary 8-epi-PGF2α | Changes of urinary 8-epi-PGF2α in pg/mg creatinine was assessed before and after the intervention. | 12 weeks | 
| Changes of adiponectin | Changes of adiponectin in ng/mL was assessed before and after the intervention. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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legumes, obesity, body weight, adiponectin, 8-epi-PGF2α, insulin resistance