ObeseNCT04392882
Effects of Legumes Consumption on Weight Reduction
A study testing Legume enriched diet group in people with Obese, run by Yonsei University.
Trial summary
This is a 12-week, randomized nutritional intervention study to determine the effect of legumes consumption on body weight in obese subjects. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Obese
- What is being tested?
- Legume enriched diet group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2011to 31 Mar 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.).
About this study
This is a 12-week, randomized nutritional intervention study to determine the effect of legumes consumption on body weight in obese subjects.
- Conditions
- Obese
- Being tested
- Legume enriched diet group
- Keywords
- legumes, obesity, body weight, adiponectin, 8-epi-PGF2α, insulin resistance
- Medical subject headings
- Obesity, Body Weight, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Legume enriched diet groupBehavioural
- 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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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)].
Measured: 12 weeks
Changes of serum high C-reactive
Changes of serum high C-reactive in mg/L was assessed before and after the intervention.
Measured: 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.
Measured: 12 weeks
Changes of adiponectin
Changes of adiponectin in ng/mL was assessed before and after the intervention.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2020
- Study start1 Mar 2011
- Primary completion31 Mar 2013
- Study completion31 Mar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObeseStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jong Ho Lee, Yonsei University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04392882
- Sponsor's protocol ID
- Legumes_Weight Reduction
- Status last verified
- Jan 2021
- First submitted
- 6 May 2020
- Last updated
- 22 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Legumes Consumption on Weight Reduction
- ClinicalTrials.gov ID
- NCT04392882
- Acronym / sponsor ID
- Legumes_Weight Reduction
- Conditions
- Obese
- Keywords
- legumes, obesity, body weight, adiponectin, 8-epi-PGF2α, insulin resistance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 1 Mar 2011 (actual)
- Primary completion
- 31 Mar 2013 (actual)
- Study completion
- 31 Mar 2013 (actual)
- First posted
- 19 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a 12-week, randomized nutritional intervention study to determine the effect of legumes consumption on body weight in obese subjects.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Legume enriched diet group | Experimental | 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 |
| 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 |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Behavioural | Legume enriched diet group |
Primary outcome
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.
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.
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)].
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.
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.
Changes of adiponectin
Time frame: 12 weeks
Changes of adiponectin in ng/mL was assessed before and after the intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Legume enriched diet group in people with Obese, run by Yonsei University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of BMI (time frame: 12 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2021.