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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Gastric Bypass Surgery, Obesity

Intervention / Treatment
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* Other: Liquid Meal
* Other: Solid Meal


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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Solid Meal<br>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<br> <br> |
| Other: Liquid Meal<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bariatric, Gastric Bypass, Gastric Banding,, Incretins, glucagon-like peptide-1(GLP-1), gastric inhibitory peptide (GIP)