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OpenTrials
Completed

NCT Number: NCT01938469

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

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).

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Key information

Conditions

Gastric Bypass Surgery Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

21 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

New York, 10025, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Severely obese patients undergoing gastric bypass surgery (GBP)

Treatment and study plan

liquid meal

Other

Solid meal

Other

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

St. Luke's-Roosevelt Hospital Center

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Sep 10, 2013
Registry last updated
Dec 29, 2016

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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