Effects of Legumes Consumption on Weight Reduction

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

Study Overview

• Status: Completed
• Conditions: Obese
• Intervention / Treatment: Behavioral: Legume enriched diet group

• Study Type: Interventional
• Enrollment (Actual): 400
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Behavioral: 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
No Intervention: Usual diet group; 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?

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

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2011
• Primary Completion (Actual): March 31, 2013
• Study Completion (Actual): March 31, 2013

Study Registration Dates

• First Submitted: May 6, 2020
• First Submitted That Met QC Criteria: May 13, 2020
• First Posted (Actual): May 19, 2020

Study Record Updates

• Last Update Posted (Actual): January 22, 2021
• Last Update Submitted That Met QC Criteria: January 19, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: obesity; insulin resistance; body weight; legumes; adiponectin; 8-epi-PGF2α
• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Loss
• Other Study ID Numbers: Legumes_Weight Reduction

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No