Back to results

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

Primary Purpose

Gastric Bypass Surgery, Obesity

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Liquid Meal

Solid Meal

About this trial

This is an interventional basic science trial for Gastric Bypass Surgery focused on measuring Bariatric, Gastric Bypass, Gastric Banding,, Incretins, glucagon-like peptide-1(GLP-1), gastric inhibitory peptide (GIP)

Eligibility Criteria

21 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Severely obese patients undergoing gastric bypass surgery (GBP)

Sites / Locations

St. Lukes- Roosevelt Hospital- New York Obesity Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

Solid Meal

Liquid Meal

Arm Description

Participants in this group will be administered only solid meals on both study visits completed before surgery (T0) and 12-15 months after (T1).

Participants in this group will be administered only liquid meals on both study visits completed before surgery (T0) and 12-15 months after (T1).

Outcomes

Primary Outcome Measures

Changes in gut peptides after gastric bypass, during either a liquid or solid meal, or single or multiple isocaloric meals.

Changes in diet induced thermogenesis after gastric bypass, during either a liquid or solid meal, or single or multiple isocaloric meals.

Changes in insulin levels after gastric bypass, during either a liquid or solid meal, or single or multiple isocaloric meals.

Changes in glucose levels after gastric bypass, during either a liquid or solid meal, or single or multiple isocaloric meals.

Changes in satiety after gastric bypass, during either a liquid or solid meal, or single or multiple isocaloric meals.

Secondary Outcome Measures

Full Information

NCT ID

NCT01938469

First Posted

August 21, 2013

Last Updated

December 28, 2016

Sponsor

St. Luke's-Roosevelt Hospital Center

Collaborators

National Institutes of Health (NIH)

1. Study Identification

Unique Protocol Identification Number

NCT01938469

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2016

Overall Recruitment Status

Completed

Study Start Date

September 2010 (undefined)

Primary Completion Date

July 2014 (Actual)

Study Completion Date

July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

St. Luke's-Roosevelt Hospital Center

Collaborators

National Institutes of Health (NIH)

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastric Bypass Surgery, Obesity

Keywords

Bariatric, Gastric Bypass, Gastric Banding,, Incretins, glucagon-like peptide-1(GLP-1), gastric inhibitory peptide (GIP)

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

33 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Solid Meal

Arm Type

Other

Arm Description

Participants in this group will be administered only solid meals on both study visits completed before surgery (T0) and 12-15 months after (T1).

Arm Title

Liquid Meal

Arm Type

Other

Arm Description

Participants in this group will be administered only liquid meals on both study visits completed before surgery (T0) and 12-15 months after (T1).

Intervention Type

Other

Intervention Name(s)

Liquid Meal

Intervention Type

Other

Intervention Name(s)

Solid Meal

Primary Outcome Measure Information:

Title

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

Title

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

Title

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

Title

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

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Severely obese patients undergoing gastric bypass surgery (GBP)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Blandine Laferrere, MD

Organizational Affiliation

New York Obesity Nutrition Research Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

St. Lukes- Roosevelt Hospital- New York Obesity Research Center

City

New York

State/Province

New York

ZIP/Postal Code

10025

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs