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Encapsulated Nutrients' Acute Effects on Appetite; ENcapSulated, nUtRiEnts (ENSURE)

NCT03284554 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2018-02-19

No results posted yet for this study

Summary

A double-blind, randomized crossover design with four arms including three experimental conditions and placebo will be applied. After having successfully completed screening procedures, eligible participants will be invited to four separate test days. The test days cannot be within the same week, however there is no upper limit for days in between, as long as the participants remain weight stable and do not change diet or physical activity level. Significant changes in diet, physical activity level (evaluated by the sub-investigator) or weight change ±3 kg over the course of the study (from screening to completion of the last test day) results in exclusion of that subject.

Conditions

  • Appetite; Lack or Loss, Nonorganic Origin

Interventions

DIETARY_SUPPLEMENT

Encapsulated nutrients

Amino acid + Lipid; Probiotic bacteria

DIETARY_SUPPLEMENT

Non-encapsulated nutrients

Amino acid + Lipid; Probiotic bacteria

DIETARY_SUPPLEMENT

Placebo

Nutrient not expected to stimulate release of GLP-1 and PYY

Sponsors & Collaborators

  • Biocare Copenhagen A/S

    collaborator INDUSTRY

  • Arne Astrup

    lead OTHER

Principal Investigators

  • Anders Sjödin, MD, PhD · University of Copenhagen, Department of Nutrition, Exercise and Sports

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-11-13
Primary Completion
2018-02-15
Completion
2018-02-15

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03284554 on ClinicalTrials.gov