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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01938469
• Other study ID #: 09-117
• Status: Completed
• Phase: N/A
• First received: August 21, 2013
• Last updated: December 28, 2016
• Start date: September 2010
• Est. completion date: July 2014

Study information

• Verified date: December 2016
• Source: St. Luke's-Roosevelt Hospital Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited Stated: Federal Government
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 60 Years

Eligibility

Inclusion Criteria:

• Severely obese patients undergoing gastric bypass surgery (GBP)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Gastric Bypass Surgery
• Obesity
• Weight Loss

Intervention

Other:
• Liquid Meal

• Solid Meal

Locations

Country	Name	City	State
United States	St. Lukes- Roosevelt Hospital- New York Obesity Research Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
St. Luke's-Roosevelt Hospital Center	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in gut peptides after gastric bypass, during either a liquid or solid meal, or single or multiple isocaloric meals.		1 month before GBP Surgery, and 12-15 months post surgery	No
Primary	Changes in diet induced thermogenesis after gastric bypass, during either a liquid or solid meal, or single or multiple isocaloric meals.		1 month before GBP surgery, and 12-15 months post surgery	No
Primary	Changes in insulin levels after gastric bypass, during either a liquid or solid meal, or single or multiple isocaloric meals.		1 month before GBP surgery, 12-15 months post surgery	No
Primary	Changes in glucose levels after gastric bypass, during either a liquid or solid meal, or single or multiple isocaloric meals.		1 month before GBP , 12-15 months post GBP	No
Primary	Changes in satiety after gastric bypass, during either a liquid or solid meal, or single or multiple isocaloric meals.		1 month before GBP, 12-15 months post GBP	No