Effects of Legumes Consumption on Weight Reduction

Not Applicable

Completed

• Conditions: Obese
• Interventions: Behavioral: Legume enriched diet group

• Registration Number: NCT04392882
• Lead Sponsor: Yonsei University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03-01
• Primary Completion: 2013-03-31
• Study Completion: 2013-03-31
• Study First Submitted: 2020-05-06
• Study First Submitted QC: 2020-05-13
• Study First Posted: 2020-05-19
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-19
• Last Update Posted: 2021-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

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.).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Legume enriched diet group	Legume enriched diet group	* 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 Measures

Name	Time	Method
Changes of serum high C-reactive	12 weeks	Changes of serum high C-reactive in mg/L was assessed before and after the intervention.
Changes of adiponectin	12 weeks	Changes of adiponectin in ng/mL was assessed before and after the intervention.
Changes of urinary 8-epi-PGF2α	12 weeks	Changes of urinary 8-epi-PGF2α in pg/mg creatinine was assessed before and after the intervention.
Changes of Insulin Resistance (IR)	12 weeks	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 BMI	12 weeks	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 lipid profiles	12 weeks	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-\[HDL-cholesterol+(triglycerides/5)\].