OverweightNCT00741923
Effect of Consuming Beans for One Month on Blood Lipids, Satiety, Intake Regulation and Body Weight
A study testing navy beans added to regular diet in people with Overweight and Obesity, run by University of Toronto at 1 site in Canada.
Trial summary
This project investigates the effect of regular consumption of commercially available processed white beans (5 cups per week) on food intake, body weight, blood pressure, satiety hormones and glycemic response over a 4-week period. Read more about this study
- Who is it for?
- Ages 35 to 55 years
- Conditions the study is for
- Overweight, Obesity, Metabolic Syndrome
- What is being tested?
- navy beans added to regular diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2007to Dec 2009
- 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 35 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- BMI 27-40 kg/m2
Who cannot join
- smokers and individuals who have prescribed medications over the past 6 months that could interfere with the study outcomes (i.e. statins, metformin). Breakfast skippers, those on a restricted energy diet or pregnant/lactating women
Trial locations and contacts
1 site in 1 country.
Canada1 site
Department of Nutritional Sciences, University of Toronto
Toronto, Ontario, M5S 3E2
About this study
Official title: Beans and Potatoes in the Regulation of Food Intake and Risk Factors for Chronic Diseases. Effect of Consuming Beans for One Month on Blood Lipids, Satiety, Intake Regulation and Body Weight
This project investigates the effect of regular consumption of commercially available processed white beans (5 cups per week) on food intake, body weight, blood pressure, satiety hormones and glycemic response over a 4-week period. We have chosen to provide participants with canned white beans, the most accessible and frequently consumed bean in North America. They are inexpensive, a good source of high quality nutrients and ready to eat. Based upon published literature and short-term studies conducted in our laboratory, we hypothesize that regular consumption of commercially available canned beans will increase satiety and improve the control of food intake, body weight, blood glucose and blood lipids.
Read the detailed description
The metabolic syndrome is a clustering of chronic disease risk factors, including abdominal obesity, dyslipidemia, elevated blood pressure and elevated fasting blood glucose.
A main treatment for metabolic syndrome is lifestyle modification (alterations in diet and/or physical activity patterns) resulting in weight loss.
Beans are easily incorporated into the diet and may lead to the attainment and maintenance of healthy a body weight and improved metabolic control.
Canned baked navy beans (with tomato sauce) have a low glycemic response following consumption, however, whether this effect has long-term benefits on glycemic control requires further investigation.
OBJECTIVE
To determine the effect of consuming 5 cups per week of commercially available canned navy beans over 4 weeks on risk factors associated with the metabolic syndrome.
Subjects
Inclusion criteria: Men and women (n=16) between 35 and 55 years of age with a body mass index (BMI) of 27 to 40 kg/m2.
Exclusion criteria: smoking or any major surgery/medical condition within the last 6 months, use of medications that could interfere with the study outcomes, gastrointestinal, liver or kidney disease and women who were pregnant/lactating
- Conditions
- Overweight, Obesity, Metabolic Syndrome, Diabetes, Hypertension
- Being tested
- navy beans added to regular diet
- Keywords
- beans, pulses, satiety, appetite, obesity, overweight, diabetes, metabolic syndrome, hypertension, blood glucose, insulin, cholesterol, HDL, LDL, leptin, GLP-1, adiponectin, Peptide YY, diet
- Medical subject headings
- Overweight, Obesity, Metabolic Syndrome, Diabetes Mellitus, Hypertension, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
navy beans added to regular dietOther
Also called Heinz beans
5 cups per week of commercially available white beans for 4-weeks
| Study group | Role | What they receive |
|---|---|---|
| Bean group | Experimental | A group consuming 5 cups/week of navy beans for a month Receives: Other: navy beans added to regular diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
body weight, waist circumference, blood glucose, satiety hormones, and blood lipids, inflammation factor, and glycated haemoglobin
Measured: at the beginning and at the end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2008 (estimated)
- Study startNov 2007
- Primary completionSep 2008
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by University of TorontoThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Ontario Ministry of Agriculture, Food and Rural Affairs
- Responsible party
- Principal investigator, G. Harvey Anderson, University of Toronto
- Investigators
- Harvey Anderson, Ph.D., Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00741923
- Sponsor's protocol ID
- OMAF-HEINZbeans
- Other IDs
- BOW-2008
- Status last verified
- Jun 2012
- First submitted
- 25 Aug 2008
- Last updated
- 15 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beans and Potatoes in the Regulation of Food Intake and Risk Factors for Chronic Diseases. Effect of Consuming Beans for One Month on Blood Lipids, Satiety, Intake Regulation and Body Weight
- ClinicalTrials.gov ID
- NCT00741923
- Acronym / sponsor ID
- OMAF-HEINZbeans
- Conditions
- Overweight, Obesity, Metabolic Syndrome, Diabetes, Hypertension
- Keywords
- beans, pulses, satiety, appetite, obesity, overweight, diabetes, metabolic syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Collaborators
- Ontario Ministry of Agriculture, Food and Rural Affairs
- Study start
- Nov 2007
- Primary completion
- Sep 2008 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 26 Aug 2008 (estimated)
- 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 project investigates the effect of regular consumption of commercially available processed white beans (5 cups per week) on food intake, body weight, blood pressure, satiety hormones and glycemic response over a 4-week period. We have chosen to provide participants with canned white beans, the most accessible and frequently consumed bean in North America. They are inexpensive, a good source of high quality nutrients and ready to eat. Based upon published literature and short-term studies conducted in our laboratory, we hypothesize that regular consumption of commercially available canned beans will increase satiety and improve the control of food intake, body weight, blood glucose and blood lipids.
Detailed description
The metabolic syndrome is a clustering of chronic disease risk factors, including abdominal obesity, dyslipidemia, elevated blood pressure and elevated fasting blood glucose.
A main treatment for metabolic syndrome is lifestyle modification (alterations in diet and/or physical activity patterns) resulting in weight loss.
Beans are easily incorporated into the diet and may lead to the attainment and maintenance of healthy a body weight and improved metabolic control.
Canned baked navy beans (with tomato sauce) have a low glycemic response following consumption, however, whether this effect has long-term benefits on glycemic control requires further investigation.
OBJECTIVE
To determine the effect of consuming 5 cups per week of commercially available canned navy beans over 4 weeks on risk factors associated with the metabolic syndrome.
Subjects
Inclusion criteria: Men and women (n=16) between 35 and 55 years of age with a body mass index (BMI) of 27 to 40 kg/m2.
Exclusion criteria: smoking or any major surgery/medical condition within the last 6 months, use of medications that could interfere with the study outcomes, gastrointestinal, liver or kidney disease and women who were pregnant/lactating
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bean group | Experimental | Other: navy beans added to regular dietA group consuming 5 cups/week of navy beans for a month |
Who may qualify
- Ages
- 35 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- BMI 27-40 kg/m2
Key exclusion criteria (1 listed)
- smokers and individuals who have prescribed medications over the past 6 months that could interfere with the study outcomes (i.e. statins, metformin). Breakfast skippers, those on a restricted energy diet or pregnant/lactating women
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 |
|---|---|---|
| navy beans added to regular dietAlso: Heinz beans5 cups per week of commercially available white beans for 4-weeks | Other | Bean group |
Primary outcome
body weight, waist circumference, blood glucose, satiety hormones, and blood lipids, inflammation factor, and glycated haemoglobin
Time frame: at the beginning and at the end of study
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 15 Jun 2012.
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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.
Harvey Anderson, Ph.D. principal investigator
University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing navy beans added to regular diet in people with Overweight and Obesity, run by University of Toronto at 1 site in Canada.
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 1 inclusion and 1 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 15 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
body weight, waist circumference, blood glucose, satiety hormones, and blood lipids, inflammation factor, and glycated haemoglobin (time frame: at the beginning and at the end of study). 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 15 Jun 2012.