Effect of Meal Number, Frequency, and Form on Satiety and Metabolism After Weight Loss Surgery

December 28, 2016 updated by: St. Luke's-Roosevelt Hospital Center
Analyze the effect of meal pattern (meal number, frequency, and form) on satiety, gut peptides, insulin, and glucose levels in individuals before and 12-15 months after gastric bypass surgery (GBP).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The main goal is to study the effect of meal number, size and texture on metabolism and incretin levels after GBP. Patients will be studied before GBP (T0) and 12-15 months after GBP (T1). At T0 and T1, patients will come for 2 study days for 8 hours: On one study day, a single meal will be served, on the second study day, three small isocaloric meals, with the order of the conditions randomly assigned. The total amount of calories and the overall nutrient composition will be equivalent between conditions. The meals will be either all solid or all liquid. Patients enrolled in the study will be randomly assigned to solid or liquid test meals.

Gastric emptying will be measured by the acetaminophen test.

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10025
        • St. Lukes- Roosevelt Hospital- New York Obesity Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Severely obese patients undergoing gastric bypass surgery (GBP)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Solid Meal
Participants in this group will be administered only solid meals on both study visits completed before surgery (T0) and 12-15 months after (T1).
Other: Solid Meal
Other: Liquid Meal
Participants in this group will be administered only liquid meals on both study visits completed before surgery (T0) and 12-15 months after (T1).
Other: Liquid Meal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in gut peptides after gastric bypass, during either a liquid or solid meal, or single or multiple isocaloric meals.
Time Frame: 1 month before GBP Surgery, and 12-15 months post surgery
1 month before GBP Surgery, and 12-15 months post surgery
Changes in diet induced thermogenesis after gastric bypass, during either a liquid or solid meal, or single or multiple isocaloric meals.
Time Frame: 1 month before GBP surgery, and 12-15 months post surgery
1 month before GBP surgery, and 12-15 months post surgery
Changes in insulin levels after gastric bypass, during either a liquid or solid meal, or single or multiple isocaloric meals.
Time Frame: 1 month before GBP surgery, 12-15 months post surgery
1 month before GBP surgery, 12-15 months post surgery
Changes in glucose levels after gastric bypass, during either a liquid or solid meal, or single or multiple isocaloric meals.
Time Frame: 1 month before GBP , 12-15 months post GBP
1 month before GBP , 12-15 months post GBP
Changes in satiety after gastric bypass, during either a liquid or solid meal, or single or multiple isocaloric meals.
Time Frame: 1 month before GBP, 12-15 months post GBP
1 month before GBP, 12-15 months post GBP

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Luke's-Roosevelt Hospital Center

Collaborators

National Institutes of Health (NIH)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

August 21, 2013

First Submitted That Met QC Criteria

September 4, 2013

First Posted (Estimate)

September 10, 2013

Study Record Updates

Last Update Posted (Estimate)

December 29, 2016

Last Update Submitted That Met QC Criteria

December 28, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09-117 (Other Identifier: Memorial Sloan-Kettering Cancer Center)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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