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Trial record 30 of 395 for:    PYY

The Effect of Macronutrients on Satiety and Gut Hormone Responses (Microcapsule)

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ClinicalTrials.gov Identifier: NCT03466047
Recruitment Status : Active, not recruiting
First Posted : March 15, 2018
Last Update Posted : August 15, 2018
Sponsor:
Information provided by (Responsible Party):
Carel Le Roux, Imperial College London

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Eating Behavior Dietary Supplement: Protein microcapsule released in stomach Dietary Supplement: Protein microcapsule released in distal bowel Dietary Supplement: Fat microcapsule released in stomach Dietary Supplement: Fat Microcapsule released in distal bowel Dietary Supplement: CHO released in stomach Dietary Supplement: CHO microcapsule released in distal bowel Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: A Physiological Study on the Effect of Macronutrients Delivery to the Proximal and Distal Small Bowel on Satiety and Gut Hormone Responses
Actual Study Start Date : March 15, 2018
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : January 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones

Arm Intervention/treatment
Experimental: Protein distal bowel
Protein microcapsule released in distal bowel Encapsulated macronutrients in a drink
Dietary Supplement: Protein microcapsule released in distal bowel
Encapsulated macronutrients in a drink

Experimental: Protein stomach
Protein microcapsule released in stomach Encapsulated macronutrients in a drink
Dietary Supplement: Protein microcapsule released in stomach
Encapsulated macronutrients in a drink

Experimental: CHO distal bowel
CHO microcapsule released in distal bowel CHO microcapsule released in distal bowel
Dietary Supplement: CHO microcapsule released in distal bowel
Encapsulated macronutrients in a drink

Experimental: CHO stomach
CHO released in stomach CHO released in stomach
Dietary Supplement: CHO released in stomach
Encapsulated macronutrients in a drink

Experimental: Fat distal bowel
Fat Microcapsule released in distal bowel Fat Microcapsule released in distal bowel
Dietary Supplement: Fat Microcapsule released in distal bowel
Encapsulated macronutrients in a drink

Experimental: Fat stomach
Fat microcapsule released in stomach Encapsulated macronutrients in a drink
Dietary Supplement: Fat microcapsule released in stomach
Encapsulated macronutrients in a drink




Primary Outcome Measures :
  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 (GLP-1, PYY) to determine the response to macronutrients in different release (stomach vs small intestine) locations


Secondary Outcome Measures :
  1. Total intake (kcal) 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. hunger VAS scores [ Time Frame: 3 hours ]
    3 hours area under the curve (AUC) for hunger VAS scores to determine hunger levels of participants



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03466047


Locations
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Ireland
Clinical Research Centre
Dublin, Ireland, Dublin 4
Sponsors and Collaborators
Imperial College London
Investigators
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Principal Investigator: Carel le Roux Imperial College London

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Responsible Party: Carel Le Roux, Professor, Imperial College London
ClinicalTrials.gov Identifier: NCT03466047     History of Changes
Other Study ID Numbers: Microcapsule
First Posted: March 15, 2018    Key Record Dates
Last Update Posted: August 15, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Hormones
Nutrients
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Growth Substances