Effects of Legumes Consumption on Weight Reduction

Obese Clinical Trial

Official title:

Effects of Legumes Consumption on Weight Reduction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04392882
• Other study ID #: Legumes_Weight Reduction
• Status: Completed
• Phase: N/A
• Start date: March 1, 2011
• Est. completion date: March 31, 2013

Study information

• Verified date: January 2021
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: March 31, 2013
• Est. primary completion date: March 31, 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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.).

Related Conditions & MeSH terms

• Obese
• Weight Loss

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Changes of serum high C-reactive	Changes of serum high C-reactive in mg/L was assessed before and after the intervention.	12 weeks
Primary	Changes of urinary 8-epi-PGF2a	Changes of urinary 8-epi-PGF2a in pg/mg creatinine was assessed before and after the intervention.	12 weeks
Primary	Changes of adiponectin	Changes of adiponectin in ng/mL was assessed before and after the intervention.	12 weeks