Back to results

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

Primary Purpose

Appetite; Lack or Loss, Nonorganic Origin

Status

Completed

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

Encapsulated nutrients

Non-encapsulated nutrients

Placebo

About this trial

This is an interventional prevention trial for Appetite; Lack or Loss, Nonorganic Origin focused on measuring Satiety, Nutrients, Appetite, Encapsulation, Lipid, Amino acid, Probiotic bacteria

Eligibility Criteria

18 Years - 60 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

Participants who have provided written informed consent
Healthy men
Age between 18 and 60 years
BMI between 18.5-32 kg/m2
Regular breakfast eaters (eating breakfast ≥ 4 times a week)

Exclusion Criteria:

Participants unable to consume or known to get nausea from consuming 20 medium sized capsules (placebo capsules will be provided at screening for test of ability to consume the relevant amount of capsules)
Participants not able to comply with the study protocol, including consumption of the specific study foods (pictures of study foods shown at screening)
Any known food allergies or food intolerance likely to affect the present study
Significant health problems as judged by the principal investigator
Taking any medication or supplements known to affect appetite or body weight within the past month and/or during the study as judged by the study professional
Intake of probiotic supplements (any kind of supplements but not including foods containing probiotic) < 4 weeks before study start
Intake of probiotic supplements (any kind of supplements but not including foods containing probiotic) during the study
Use of systemic medical treatment likely to interfere with evaluation of the study parameters as judged by the principal investigator
Smoking, smoking cessation within the past 3 months or nicotine use (electronic cigarettes, gum etc.). Irregular smokers accepted
Self-reporting currently dieting or having lost/gained significant amount of weight (±3 kg) in the previous 3 months
Significant weight changes (±3 kg) over the course of the study (from screening to completion of last test day)
Significant changes in physical activity patterns in the past 4 weeks or significant changes over the course of the study (from screening to completion of last test day) as judged by the sub-investigator
Significant changes in diet in the past 4 weeks or significant changes over the course of the study (from screening to completion of last test day) as judged by the sub-investigator
Participants who work in appetite related areas
Simultaneous or within the past month participating in other clinical trials that can interfere with the study

Sites / Locations

Department of Nutrition, Exercise and Sports

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Sham Comparator

Placebo Comparator

Arm Label

Encapsulated nutients

Non-encapsulated nutrients

Placebo

Arm Description

Encapsulated nutrients known to be able to stimulate GLP-1 and PYY release. Encapsulated with coating providing release at pH≈7.0 (in the distal part of the ileum). The encapsulated nutrients will be provided 30 minutes prior to the ad libitum test breakfast and 3 hour prior to the ad libitum test lunch, respectively.

Nutrients known to be able to stimulate GLP-1 and PYY release if they are encapsulated to provide release at pH ≈7.0 (in the distal part of the ileum). The same capsules in a non-coated form will be provided in order to study the effect of the coating. The non-encapsulated nutrients will be provided 30 minutes prior to the ad libitum test breakfast and 3 hour prior to the ad libitum test lunch, respectively.

Nutrients known to have limited stimulation on GLP-1 and PYY release. Encapsulated with coating providing release at pH≈7.0 (in the distal part of the ileum). The placebo capsules will be provided 30 minutes prior to the ad libitum test breakfast and 3 hour prior to the ad libitum test lunch, respectively.

Outcomes

Primary Outcome Measures

Reduced energy intake

Assessments of total ad libitum test meal energy intake when exposed to one or more of the encapsulated nutrients compared to the non-encapsulated nutrients and placebo

Secondary Outcome Measures

Subjective appetite sensations

Evaluations of each of the subjective appetite sensations assessed by visual analogue scale (VAS) (satiety, fullness, hunger, prospective food consumption, desire to eat)

Subjective appetite sensations in relation to energy consumed

Assessing the satiety quotient (SQ)

Full Information

NCT ID

NCT03284554

First Posted

September 13, 2017

Last Updated

February 15, 2018

Sponsor

Arne Astrup

Collaborators

Biocare Copenhagen A/S

1. Study Identification

Unique Protocol Identification Number

NCT03284554

Brief Title

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

Acronym

ENSURE

Official Title

Encapsulated Nutrients' Acute Effects on Appetite

Study Type

Interventional

2. Study Status

Record Verification Date

February 2018

Overall Recruitment Status

Completed

Study Start Date

November 13, 2017 (Actual)

Primary Completion Date

February 15, 2018 (Actual)

Study Completion Date

February 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Arne Astrup

Collaborators

Biocare Copenhagen A/S

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

Detailed Description

For standardization, 48 hours before the test days, the participants will be asked to consume a regular diet compliant to what they usually eat and no excessive alcohol consumption (not above 5 units and no alcohol at all from 8 pm the night before the test days) or intense physical activity compared to what they normally do is allowed. Additionally, the participants must arrive at the study facilities in the morning after an overnight fast (from 10 pm) using non strenuous means of transportation. Furthermore, over the course of the study (from screening (visit 1) to completion of the last test day (visit 5)), the participants are not allowed to change body weight (±3 kg), diet or physical activity level (as judged by the sub-investigator). The participants will be weighed and asked about compliance with additional standardization in a room away from the other participants before initiating each test day. Possible in-compliance with the standardization will be judged by the sub-investigator whether to result in re-scheduling of the visit or to be recorded as a protocol deviation. Participants arrive at the study facility at 07:30 in the morning. Compliance with standardization is controlled along with registration of possible adverse events and use of concomitant medications. During the test days, participants are settled together in an open office, where they are separated at individual tables. During the meals, participants are settled into individual feeding cubicles, where they cannot see each other and are instructed not to talk to each other. Visual analogue scales (VAS') will be completed for measurement of fasting subjective appetite levels. The test products (capsules) will be provided 30 minutes prior to an ad libitum test breakfast and 3 hour prior to an ad libitum test lunch. Immediately before and after each episode of capsules and food consumption and at 30 minutes intervals, VAS' will be completed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Appetite; Lack or Loss, Nonorganic Origin

Keywords

Satiety, Nutrients, Appetite, Encapsulation, Lipid, Amino acid, Probiotic bacteria

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Model Description

A double-blind, randomized crossover design with four arms including three experimental conditions and placebo

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

Double-blind

Allocation

Randomized

Enrollment

34 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Encapsulated nutients

Arm Type

Active Comparator

Arm Description

Arm Title

Non-encapsulated nutrients

Arm Type

Sham Comparator

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Dietary Supplement

Intervention Name(s)

Encapsulated nutrients

Intervention Description

Amino acid + Lipid; Probiotic bacteria

Intervention Type

Dietary Supplement

Intervention Name(s)

Non-encapsulated nutrients

Intervention Description

Amino acid + Lipid; Probiotic bacteria

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Reduced energy intake

Description

Assessments of total ad libitum test meal energy intake when exposed to one or more of the encapsulated nutrients compared to the non-encapsulated nutrients and placebo

Time Frame

up to day 4

Secondary Outcome Measure Information:

Title

Subjective appetite sensations

Description

Evaluations of each of the subjective appetite sensations assessed by visual analogue scale (VAS) (satiety, fullness, hunger, prospective food consumption, desire to eat)

Time Frame

Three hours during each test day between test day 1, 2, 3 and 4 (acute effect)

Title

Subjective appetite sensations in relation to energy consumed

Description

Assessing the satiety quotient (SQ)

Time Frame

up to day 4

Other Pre-specified Outcome Measures:

Title

Subjective nausea assessments

Description

VAS assessments for nausea throughout the study test day

Time Frame

Three hours during each test day between test day 1, 2, 3 and 4 (acute effect)

Title

Subjective nausea assessments

Description

End of day questionnaire assessing feeling of nausea after leaving the study facility

Time Frame

up to day 4

10. Eligibility

Sex

Male

Gender Based

Yes

Gender Eligibility Description

Selfreporting

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Participants who have provided written informed consent Healthy men Age between 18 and 60 years BMI between 18.5-32 kg/m2 Regular breakfast eaters (eating breakfast ≥ 4 times a week) Exclusion Criteria: Participants unable to consume or known to get nausea from consuming 20 medium sized capsules (placebo capsules will be provided at screening for test of ability to consume the relevant amount of capsules) Participants not able to comply with the study protocol, including consumption of the specific study foods (pictures of study foods shown at screening) Any known food allergies or food intolerance likely to affect the present study Significant health problems as judged by the principal investigator Taking any medication or supplements known to affect appetite or body weight within the past month and/or during the study as judged by the study professional Intake of probiotic supplements (any kind of supplements but not including foods containing probiotic) < 4 weeks before study start Intake of probiotic supplements (any kind of supplements but not including foods containing probiotic) during the study Use of systemic medical treatment likely to interfere with evaluation of the study parameters as judged by the principal investigator Smoking, smoking cessation within the past 3 months or nicotine use (electronic cigarettes, gum etc.). Irregular smokers accepted Self-reporting currently dieting or having lost/gained significant amount of weight (±3 kg) in the previous 3 months Significant weight changes (±3 kg) over the course of the study (from screening to completion of last test day) Significant changes in physical activity patterns in the past 4 weeks or significant changes over the course of the study (from screening to completion of last test day) as judged by the sub-investigator Significant changes in diet in the past 4 weeks or significant changes over the course of the study (from screening to completion of last test day) as judged by the sub-investigator Participants who work in appetite related areas Simultaneous or within the past month participating in other clinical trials that can interfere with the study

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Anders Sjödin, MD, PhD

Organizational Affiliation

University of Copenhagen, Department of Nutrition, Exercise and Sports

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Nutrition, Exercise and Sports

City

Copenhagen

State/Province

Frederiksberg

ZIP/Postal Code

1958

Country

Denmark

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

No IPD will be shared

Learn more about this trial

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

We'll reach out to this number within 24 hrs