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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Legume diet group | Behavioral | about 1 1/2 cups of legumes included in lunch and dinner meals |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Gastric Emptying Time | Compare the effects of the high-legume and control diets on gastric emptying time | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Terry J Hartman, PhD, MPH, RD | Rollins School of Public Health, Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Morehouse | Atlanta | Georgia | 30310 | United States | ||
| Emory ACTSI |
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| ID | Title | Description |
|---|---|---|
| FG000 | Legume Diet Group | 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. Legume diet group: about 1 1/2 cups of legumes included in lunch and dinner meals Smartpill: to assess how long food takes to pass through the digestive system legumes: about 1 1/2 cups of legumes included in lunch and dinner meals |
| FG001 | Control Diet Group | 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. Control diet group: no legumes in lunch or dinner meals Smartpill: to assess how long food takes to pass through the digestive system |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Legume Diet Group | 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. Legume diet group: about 1 1/2 cups of legumes included in lunch and dinner meals Smartpill: to assess how long food takes to pass through the digestive system legumes: about 1 1/2 cups of legumes included in lunch and dinner meals |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Median | Full Range | lbs | Baseline to 8 weeks |
|
8 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Legume Diet Group | 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. Legume diet group: about 1 1/2 cups of legumes included in lunch and dinner meals Smartpill: to assess how long food takes to pass through the digestive system legumes: about 1 1/2 cups of legumes included in lunch and dinner meals |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hartman, Terry Professor, SPH Epidemiology | Emory Unioversity | 404-727-8713 | terryl.johnson.hartman@emory.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 19, 2015 | Dec 11, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D015179 | Colorectal Neoplasms |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| Control diet group | Behavioral | no legumes in lunch or dinner meals |
|
| Smartpill | Device | to assess how long food takes to pass through the digestive system |
|
| legumes | Other | about 1 1/2 cups of legumes included in lunch and dinner meals |
|
| 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. | Baseline to 8 weeks |
| Satiety | Use self-reported satiety questionnaire to compare short-term responses to test meals. | Time course response at baseline and 8 weeks |
| Atlanta |
| Georgia |
| 30322 |
| United States |
| BG001 | Control Diet Group | 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. Control diet group: no legumes in lunch or dinner meals Smartpill: to assess how long food takes to pass through the digestive system |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Control Diet Group |
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. Control diet group: no legumes in lunch or dinner meals Smartpill: to assess how long food takes to pass through the digestive system |
|
|
| Secondary | Gastric Emptying Time | Compare the effects of the high-legume and control diets on gastric emptying time | Posted | Median | Full Range | hours | 8 weeks |
|
|
|
| Secondary | 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. | Posted | Mean | 95% Confidence Interval | mg/dl | Baseline to 8 weeks |
|
|
|
| Secondary | Energy Intake | Compare the effects of the high-legume and control diets on self-reported dietary intake measured by telephone 24-hour dietary recalls. | Data were collected but not analyzed due to a lack of funding. | Posted | Baseline to 8 weeks |
|
|
| Secondary | Satiety | Use self-reported satiety questionnaire to compare short-term responses to test meals. | Data were collected but not analyzed due to a lack of funding. | Posted | Time course response at baseline and 8 weeks |
|
|
| 0 |
| 7 |
| 0 |
| 7 |
| 0 |
| 7 |
| EG001 | Control Diet Group | 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. Control diet group: no legumes in lunch or dinner meals Smartpill: to assess how long food takes to pass through the digestive system | 0 | 5 | 0 | 5 | 0 | 5 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D001836 | Body Weight Changes |