NCT04392882

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2011

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2013

Completed
7.1 years until next milestone

First Submitted

Initial submission to the registry

May 6, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 19, 2020

Completed
Last Updated

January 22, 2021

Status Verified

January 1, 2021

Enrollment Period

2.1 years

First QC Date

May 6, 2020

Last Update Submit

January 19, 2021

Conditions

Obese

Keywords

legumesobesitybody weightadiponectin8-epi-PGF2αinsulin resistance

Outcome Measures

Primary Outcomes (6)

  • 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

Study Arms (2)

Legume enriched diet group

EXPERIMENTAL

* 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

Usual diet group

NO INTERVENTION

* 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

Interventions

Legume enriched diet groupBEHAVIORAL

* 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

Legume enriched diet group

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

ObesityBody WeightInsulin Resistance

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Principal Investigator

Study Record Dates

First Submitted

May 6, 2020

First Posted

May 19, 2020

Study Start

March 1, 2011

Primary Completion

March 31, 2013

Study Completion

March 31, 2013

Last Updated

January 22, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share