Lipid Encapsulation for Ileal Brake Activation

NCT ID: NCT03025997

Last Updated: 2017-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-24

Study Completion Date

2017-03-31

Brief Summary

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This study evaluates the ability of encapsulation of orally applied lipids in a yoghurt snack to modify ad libitum food intake and satiety, without GI symptoms. Every subject receives two treatments (active, and placebo) on two different days, following a randomized cross-over design.

Detailed Description

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Conditions

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Appetite Regulation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Active yoghurt

Yoghurt snack containing encapsulated lipid

Group Type ACTIVE_COMPARATOR

Active yoghurt

Intervention Type DIETARY_SUPPLEMENT

Active yoghurt (containing encapsulated lipid) will be ingested after a standardized breakfast, and subsequently satiety and food intake will be measured.

Placebo yoghurt

Yoghurt snack containing non-encapsulated lipid

\+ empty encapsulation matrix

Group Type PLACEBO_COMPARATOR

Placebo yoghurt

Intervention Type DIETARY_SUPPLEMENT

Placebo yoghurt (containing non-encapsulated lipid) will be ingested after a standardized breakfast, and subsequently satiety and food intake will be measured.

Interventions

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Active yoghurt

Active yoghurt (containing encapsulated lipid) will be ingested after a standardized breakfast, and subsequently satiety and food intake will be measured.

Intervention Type DIETARY_SUPPLEMENT

Placebo yoghurt

Placebo yoghurt (containing non-encapsulated lipid) will be ingested after a standardized breakfast, and subsequently satiety and food intake will be measured.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* BMI between 25-30 kg/m2
* Voluntary participation

Exclusion Criteria

* Milk (-protein or lactose)- allergy/intolerance
* History of serious GI complaints/surgeries
* Pregnancy, lactation
* Excessive alcohol consumption (\>20 per week)
* Abnormal eating behaviour
* Intention to stop smoking
* Reported unexplained weight loss or gain in the month prior to screening
* Self-admitted HIV-positive state
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Wageningen University and Research

OTHER

Sponsor Role collaborator

Maastricht University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Adrian AM Masclee, Prof.

Role: PRINCIPAL_INVESTIGATOR

azM/UM

Locations

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Maastricht University

Maastricht, , Netherlands

Site Status

Countries

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Netherlands

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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163042

Identifier Type: OTHER

Identifier Source: secondary_id

NL59245.068.16

Identifier Type: -

Identifier Source: org_study_id