ObesityNCT02269631
Legume Diet Satiety Pilot Study
A study testing Legume diet group, Smartpill and legumes in people with Obesity and Colorectal Carcinoma, run by Emory University at 2 sites in United States.
Trial summary
This pilot study is designed to test the effects of a high legume (dried bean) diet on hunger and other indicators of health over the course of eight weeks, compared to a more conventional healthy diet. Read more about this study
- Who is it for?
- Ages 40 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Colorectal Carcinoma
- What is being tested?
- Legume diet group, Smartpill and legumes
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2014to Dec 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 to 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI overweight-obese: 25.0-40 kg/m2
- Colonoscopy within the last two years that found ≥1 adenoma
- English speaking
- Ambulatory, able to come to either food distribution site to pick up food and participate in clinical examinations and laboratory tests
Who cannot join
- Serious medical condition (e.g., cancer, heart disease, kidney disease, diabetes)
- History of CRC, bowel resection, polyposis syndrome, or inflammatory bowel disease
- Smoked regularly in the past year
- Dietary restrictions substantially limiting compliance or vegetarian or Vegan diet
- Planning on changing diet or exercise behavior in the next 6 months
- Regular use of medication that may alter inflammation markers, insulin, glucose, or gut function (i.e. regular use of non-steroidal anti-inflammatory medication, insulin therapy, steroid therapy, or antibiotics)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Morehouse
Atlanta, Georgia, 30310
Emory ACTSI
Atlanta, Georgia, 30322
About this study
Official title: Legume Diet Satiety and Weight Loss Pilot Study
This pilot study is designed to test the effects of a high legume (dried bean) diet on hunger and other indicators of health over the course of eight weeks, compared to a more conventional healthy diet.
Read the detailed description
The goal of the currently proposed study is to conduct a randomized controlled feeding pilot study within a more diverse population also at high risk for colorectal carcinoma (CRC) to evaluate whether a high-legume diet will result in increased satiety and in turn will facilitate reduced energy intake and weight loss compared to a control diet provided under similar conditions. In addition, explore potential beneficial effects of the high-legume diet on gastric emptying and circulating levels of appetite-regulating hormones and other biomarkers. Dietary behaviors that are even moderately more satiating over time have the potential to enhance weight loss and could lead to a significant public health impact among populations at high risk for colorectal carcinoma (CRC) and other chronic diseases.
Towards the end of the study, the participants will do an additional test, looking at how long food takes to pass through the digestive system using a SmartPill capsule. The SmartPill is a pill about the size of a large multivitamin that can measure pH, pressure, and temperature changes, which it uses to assess where in the digestive tract it is. The participant swallows the pill, and carries around a receiver that is about the size of a deck of cards for the next 3-5 days. The SmartPill is expelled, and the receiver notifies the participant that they can return the receiver to the study personnel.
- Conditions
- Obesity, Colorectal Carcinoma
- Being tested
- Legume diet group, Control diet group, Smartpill, legumes
- Keywords
- Weight loss, Epidemiology, Nutrition
- Medical subject headings
- Obesity, Colorectal Neoplasms, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Legume diet groupBehavioural
about 1 1/2 cups of legumes included in lunch and dinner meals
Control diet groupBehavioural
no legumes in lunch or dinner meals
SmartpillDevice
to assess how long food takes to pass through the digestive system
legumesOther
about 1 1/2 cups of legumes included in lunch and dinner meals
| Study group | Role | What they receive |
|---|---|---|
| Legume diet group | Experimental | Meals will include approximately 1 ½ cups of cooked legumes, such as pinto, baked and navy beans as part of your 2 daily main dishes (lunch and dinner) and additional foods and snacks, preferably from the recommended healthy foods list. The smartpill will be administered at the end of the study. Receives: Behavioral: Legume diet group; Device: Smartpill; Other: legumes |
| Control diet group | Active comparator | Meals will be healthy, typical American foods (without legumes) for 2 daily main dishes and additional foods and snacks, preferably from the recommended healthy foods list.The smartpill will be administered at the end of the study. Receives: Behavioral: Control diet group; Device: Smartpill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Weight
Evaluate the effects of a high-legume diet compared to a control diet with a similar macronutrient profile on weight change in a randomized controlled feeding study.
Measured: Baseline to 8 weeks
Secondary outcomes (4)
Gastric Emptying Time
Compare the effects of the high-legume and control diets on gastric emptying time
Measured: 8 weeks
Change in Plasma Insulin Level (Biomarker of Appetite Regulation)
Compare the effects of the high-legume and control diets on plasma insulin level in a meal response time (30 min) course experiment.
Measured: Baseline to 8 weeks
Energy Intake
Compare the effects of the high-legume and control diets on self-reported dietary intake measured by telephone 24-hour dietary recalls.
Measured: Baseline to 8 weeks
Satiety
Use self-reported satiety questionnaire to compare short-term responses to test meals.
Measured: Time course response at baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2014 (estimated)
- Study startDec 2014
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Emory 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Terry Hartman, Emory University
- Investigators
- Terry J Hartman, PhD, MPH, RD, Principal investigator, Rollins School of Public Health, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02269631
- Sponsor's protocol ID
- IRB00075830
- Status last verified
- Jan 2019
- First submitted
- 17 Oct 2014
- Last updated
- 25 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Legume Diet Satiety and Weight Loss Pilot Study
- ClinicalTrials.gov ID
- NCT02269631
- Acronym / sponsor ID
- IRB00075830
- Conditions
- Obesity, Colorectal Carcinoma
- Keywords
- Weight loss, Epidemiology, Nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 21 Oct 2014 (estimated)
- Results
- Posted 25 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot study is designed to test the effects of a high legume (dried bean) diet on hunger and other indicators of health over the course of eight weeks, compared to a more conventional healthy diet.
Detailed description
The goal of the currently proposed study is to conduct a randomized controlled feeding pilot study within a more diverse population also at high risk for colorectal carcinoma (CRC) to evaluate whether a high-legume diet will result in increased satiety and in turn will facilitate reduced energy intake and weight loss compared to a control diet provided under similar conditions. In addition, explore potential beneficial effects of the high-legume diet on gastric emptying and circulating levels of appetite-regulating hormones and other biomarkers. Dietary behaviors that are even moderately more satiating over time have the potential to enhance weight loss and could lead to a significant public health impact among populations at high risk for colorectal carcinoma (CRC) and other chronic diseases.
Towards the end of the study, the participants will do an additional test, looking at how long food takes to pass through the digestive system using a SmartPill capsule. The SmartPill is a pill about the size of a large multivitamin that can measure pH, pressure, and temperature changes, which it uses to assess where in the digestive tract it is. The participant swallows the pill, and carries around a receiver that is about the size of a deck of cards for the next 3-5 days. The SmartPill is expelled, and the receiver notifies the participant that they can return the receiver to the study personnel.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Legume diet group | Experimental | Behavioral: Legume diet group, Device: Smartpill, Other: legumesMeals will include approximately 1 ½ cups of cooked legumes, such as pinto, baked and navy beans as part of your 2 daily main dishes (lunch and dinner) and additional foods and snacks, preferably from the recommended healthy foods list. The smartpill will be administered at the end of the study. |
| Control diet group | Active comparator | Behavioral: Control diet group, Device: SmartpillMeals will be healthy, typical American foods (without legumes) for 2 daily main dishes and additional foods and snacks, preferably from the recommended healthy foods list.The smartpill will be administered at the end of the study. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- BMI overweight-obese: 25.0-40 kg/m2
- Colonoscopy within the last two years that found ≥1 adenoma
- English speaking
- Ambulatory, able to come to either food distribution site to pick up food and participate in clinical examinations and laboratory tests
Key exclusion criteria (6 listed)
- Serious medical condition (e.g., cancer, heart disease, kidney disease, diabetes)
- History of CRC, bowel resection, polyposis syndrome, or inflammatory bowel disease
- Smoked regularly in the past year
- Dietary restrictions substantially limiting compliance or vegetarian or Vegan diet
- Planning on changing diet or exercise behavior in the next 6 months
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 diet groupabout 1 1/2 cups of legumes included in lunch and dinner meals | Behavioural | Legume diet group |
| Control diet groupno legumes in lunch or dinner meals | Behavioural | Control diet group |
| Smartpillto assess how long food takes to pass through the digestive system | Device | Control diet group, Legume diet group |
| legumesabout 1 1/2 cups of legumes included in lunch and dinner meals | Other | Legume diet group |
Primary outcome
Change in Weight
Time frame: Baseline to 8 weeks
Evaluate the effects of a high-legume diet compared to a control diet with a similar macronutrient profile on weight change in a randomized controlled feeding study.
4 secondary outcomes
Gastric Emptying Time
Time frame: 8 weeks
Change in Plasma Insulin Level (Biomarker of Appetite Regulation)
Time frame: Baseline to 8 weeks
Energy Intake
Time frame: Baseline to 8 weeks
Satiety
Time frame: Time course response at baseline and 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Obesity
RecruitingObservational study
Early Tracking of Childhood Health Determinants (ETCHED) Study
Diabetes Mellitus, Obesity
Not yet recruitingPhase 2
Trial of the Combination of Alpha-Lipoic Acid and Mirabegron in Women and in Men With Obesity
Insulin Resistance, Obesity
Active, not recruiting
Growing Healthy Children and Families in Rural Arkansas
Pediatric Obesity, Health Behavior, Risky
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
Active, not recruiting
Effect of the Thrive AI Health App on Lifestyle Behaviors and Quality of Life
Diabetes Type 2, Overweight or Obesity
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.
Terry J Hartman, PhD, MPH, RD principal investigator
Rollins School of Public Health, Emory University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Legume diet group, Smartpill and legumes in people with Obesity and Colorectal Carcinoma, run by Emory University at 2 sites in United States.
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 4 inclusion and 6 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 25 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Yes. Results are posted in the registry (first posted 25 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Weight (time frame: Baseline to 8 weeks). 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 25 Jan 2019; AzTrials last refreshed its copy on 28 Oct 2026.