NCT02269631

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Dec 2014

Typical duration for not_applicable obesity

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 17, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 21, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2014

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

January 25, 2019

Completed
Last Updated

January 25, 2019

Status Verified

January 1, 2019

Enrollment Period

3 years

First QC Date

October 17, 2014

Results QC Date

December 12, 2018

Last Update Submit

January 24, 2019

Conditions

ObesityColorectal Carcinoma

Keywords

Weight lossEpidemiologyNutrition

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (4)

  • Gastric Emptying Time

    8 weeks

  • Change in Plasma Insulin Level (Biomarker of Appetite Regulation)

    Baseline to 8 weeks

  • Energy Intake

    Baseline to 8 weeks

  • Satiety

    Time course response at baseline and 8 weeks

Study Arms (2)

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.

Behavioral: Legume diet groupDevice: SmartpillOther: 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.

Behavioral: Control diet groupDevice: Smartpill

Interventions

Legume diet groupBEHAVIORAL

about 1 1/2 cups of legumes included in lunch and dinner meals

Legume diet group
Control diet groupBEHAVIORAL

no legumes in lunch or dinner meals

Control diet group
SmartpillDEVICE

to assess how long food takes to pass through the digestive system

Control diet groupLegume diet group
legumesOTHER

about 1 1/2 cups of legumes included in lunch and dinner meals

Legume diet group

Eligibility Criteria

Age40 Years - 70 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Morehouse

Atlanta, Georgia, 30310, United States

Location

Emory ACTSI

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

ObesityColorectal NeoplasmsWeight Loss

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesBody Weight Changes

Results Point of Contact

Title
Hartman, Terry Professor, SPH Epidemiology
Organization
Emory Unioversity
terryl.johnson.hartman@emory.edu
404-727-8713

Study Officials

  • Terry J Hartman, PhD, MPH, RD

    Rollins School of Public Health, Emory University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Terry Hartman PhD, MPH, RD

Study Record Dates

First Submitted

October 17, 2014

First Posted

October 21, 2014

Study Start

December 1, 2014

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

January 25, 2019

Results First Posted

January 25, 2019

Record last verified: 2019-01

Locations

US(2)