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Completed

NCT Number: NCT04392882

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.

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Key information

Conditions

Obese Body Weight Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.).

Treatment and study plan

Legume enriched diet group

Behavioral
  • 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 outcomes

  1. Changes of BMI

    Time frame: 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.

  2. Changes of Insulin Resistance (IR)

    Time frame: 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.

  3. Changes of lipid profiles

    Time frame: 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)].

  4. Changes of serum high C-reactive

    Time frame: 12 weeks

    Changes of serum high C-reactive in mg/L was assessed before and after the intervention.

  5. Changes of urinary 8-epi-PGF2α

    Time frame: 12 weeks

    Changes of urinary 8-epi-PGF2α in pg/mg creatinine was assessed before and after the intervention.

  6. Changes of adiponectin

    Time frame: 12 weeks

    Changes of adiponectin in ng/mL was assessed before and after the intervention.

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
May 19, 2020
Registry last updated
Jan 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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