Obesity, Colorectal Carcinoma
Conditions
Keywords
Weight loss, Epidemiology, Nutrition
Brief 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.
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.
Interventions
BEHAVIORALLegume diet group
about 1 1/2 cups of legumes included in lunch and dinner meals
BEHAVIORALControl diet group
no legumes in lunch or dinner meals
DEVICESmartpill
to assess how long food takes to pass through the digestive system
OTHERlegumes
about 1 1/2 cups of legumes included in lunch and dinner meals
Sponsors
Emory University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
MALE
Age
40 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Weight | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gastric Emptying Time | 8 weeks | Compare the effects of the high-legume and control diets on gastric emptying time |
| Change in Plasma Insulin Level (Biomarker of Appetite Regulation) | Baseline to 8 weeks | Compare the effects of the high-legume and control diets on plasma insulin level in a meal response time (30 min) course experiment. |
| Energy Intake | Baseline to 8 weeks | Compare the effects of the high-legume and control diets on self-reported dietary intake measured by telephone 24-hour dietary recalls. |
| Satiety | Time course response at baseline and 8 weeks | Use self-reported satiety questionnaire to compare short-term responses to test meals. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 7 |
| 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 | 5 |
| Total | 12 |
Baseline characteristics
| Characteristic | Legume Diet Group | Control Diet Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 1 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants | 4 Participants | 10 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 3 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 5 Participants | 2 Participants | 7 Participants |
| Region of Enrollment United States | 7 participants | 5 participants | 12 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 7 Participants | 5 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 7 | 0 / 5 |
| other Total, other adverse events | 0 / 7 | 0 / 5 |
| serious Total, serious adverse events | 0 / 7 | 0 / 5 |
Outcome results
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.
Time frame: Baseline to 8 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Legume Diet Group | Change in Weight | 9.2 lbs |
| Control Diet Group | Change in Weight | 6.6 lbs |
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.
Time frame: Baseline to 8 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Legume Diet Group | Change in Plasma Insulin Level (Biomarker of Appetite Regulation) | -9.9 mg/dl |
| Control Diet Group | Change in Plasma Insulin Level (Biomarker of Appetite Regulation) | 5.9 mg/dl |
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.
Time frame: Baseline to 8 weeks
Population: Data were collected but not analyzed due to a lack of funding.
Secondary
Gastric Emptying Time
Compare the effects of the high-legume and control diets on gastric emptying time
Time frame: 8 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Legume Diet Group | Gastric Emptying Time | 25.8 hours |
| Control Diet Group | Gastric Emptying Time | 53.8 hours |
Secondary
Satiety
Use self-reported satiety questionnaire to compare short-term responses to test meals.
Time frame: Time course response at baseline and 8 weeks
Population: Data were collected but not analyzed due to a lack of funding.