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Completed

NCT Number: NCT03466047

The Effect of Macronutrients on Satiety and Gut Hormone Responses

This study is part of a research theme aiming at elucidating the physiological mechanisms of action of weight loss after gastric bypass surgery. The Roux-en-Y Gastric Bypass procedure induces pronounced and sustained weight loss, but the physiological mechanisms of action are not completely clear. Neither mechanical restriction of food intake nor malabsorption, are the main contributing factors. The enhanced postprandial responses of gut hormones (e.g. GLP-1 and PYY) which increase satiety as well as energy expenditure after surgery suggest a changed physiological set point for appetite and metabolism.

Our hypothesis is that the intake of high quantity of protein in a microcapsule form would be able to reach the distal parts of the intestinal mucosa and stimulate maximum stimulation of the anorectic gut hormones. The higher functions of the brain will respond to these strong neuroendocrine signals by ensuing satiety and fullness.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Research Centre

Dublin, Dublin 4, Ireland

About this study

Ten healthy volunteers, aged 18 to 65 years will be recruited. Each subject will be studied on six occasions one week apart. On each visit, a baseline serum sample will be drawn from each subject. In a randomized way all subjects will receive the following meals in their successive weekly visits: Option 1 High protein mixed meal in capsules that break down in the stomach, Option 2 High protein mixed meal in capsules that break down in the distal small bowel, Option 3 High fat mixed meal in capsules that break down in the stomach, Option 4 High fat mixed meal in capsules that break down in the distal small bowel, Option 5 High CHD mixed meal in capsules that break down in the stomach, Option 6 High CHD mixed meal in capsules that break down in the distal small bowel. On the same day, all subjects will be offered standard ad libitum meal to measure their food consumption. After 3 hours (i.e. at 12:00) another blood sample will be drawn. All subjects will be asked to rate their appetite on a Visual Analogue Scale (VAS). Upon VAS completion the subjects will be allowed to go home.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 18-65 years
  • Normal fasting glucose
  • Stable body weight for at least last three months
  • BMI < 30 Kg/m2
  • Capacity to consent to participate
  • Independently mobile

Exclusion criteria

  • Patients who meet any of the following criteria will be excluded:
  • Pre-diabetes Diabetes
  • Obesity
  • Smoking
  • Substance abuse
  • Pregnancy
  • Use of medications (except for oral contraceptives)
  • Chronic medical or psychiatric illness
  • Any significant abnormalities detected on physical examination, electrocardiography, or screening blood tests (measurement of complete blood count, electrolytes, fasting glucose, and liver function)

Treatment and study plan

Protein stomach

Dietary Supplement

encapsulated protein stomach

Protein distal small intestine

Dietary Supplement

encapsulated protein distal small intestine

CHO stomach

Dietary Supplement

encapsulated CHO stomach

CHO distal small intestine

Dietary Supplement

encapsulated CHO distal small intestine

Fat stomach

Dietary Supplement

encapsulated Fat stomach

Fat distal small intestine

Dietary Supplement

encapsulated Fat distal small intestine

Primary outcomes

  1. The Effect of Proteins on the Secretion of Gut Hormones From Different Parts of the Gastrointestinal Tract

    Time frame: 3 hours

    3 hours AUC for different gut hormones (PYY) to determine the response to macronutrients in different release (stomach vs small intestine) locations. AUC for timepoints 0, 30min, 60min, 120min, 180min.

Secondary outcomes

  1. Total Intake (kj) of ad Libitum Lunch Meals to Assess Food Intake

    Time frame: 3 hours

    Food intake as assessed with ad libitum lunch 3 hours after intervention

  2. Visual Analogue Scale Ratings of Hunger

    Time frame: 180min

    Visual Analogue Scale ratings of hunger at 180 min (before the meal). The scale is 10cm line with two anchors at each end. Scores are recorded by making a handwritten mark that represents a continuum between "not hungry at all" and "Extremly hungry."

    The score of 0 represents least hunger. The score of 10 represent extreme hunger.

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Registry information

Official study title

A Physiological Study on the Effect of Macronutrients Delivery to the Proximal and Distal Small Bowel on Satiety and Gut Hormone Responses

Acronym: Microcapsule

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 15, 2018
Registry last updated
Oct 20, 2020

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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