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Completed

NCT Number: NCT02269631

Legume Diet Satiety 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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Legume diet group

Behavioral

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

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Gastric Emptying Time

    Time frame: 8 weeks

    Compare the effects of the high-legume and control diets on gastric emptying time

  2. Change in Plasma Insulin Level (Biomarker of Appetite Regulation)

    Time frame: 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.

  3. Energy Intake

    Time frame: 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.

  4. Satiety

    Time frame: Time course response at baseline and 8 weeks

    Use self-reported satiety questionnaire to compare short-term responses to test meals.

Sponsors and collaborators

Lead sponsor

Emory University

Other

Registry information

Official study title

Legume Diet Satiety and Weight Loss Pilot Study

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Oct 21, 2014
Registry last updated
Jan 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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