Lipid Encapsulation for Ileal Brake Activation

The Effect of Orally Applied Encapsulated Lipids in Yoghurt on Satiety and Food Intake: a Randomized Single-blind Placebo-controlled Study With Cross-over Design

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.

Study Overview

• Status: Completed
• Conditions: Appetite Regulation
• Intervention / Treatment: Dietary supplement: Active yoghurt; Dietary supplement: Placebo yoghurt

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Maastricht, Netherlands
    • Maastricht University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Active yoghurt; Yoghurt snack containing encapsulated lipid	Dietary supplement: Active yoghurt; Active yoghurt (containing encapsulated lipid) will be ingested after a standardized breakfast, and subsequently satiety and food intake will be measured.
PLACEBO_COMPARATOR: Placebo yoghurt; Yoghurt snack containing non-encapsulated lipid + empty encapsulation matrix	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ad libitum food intake	t=0: standardized breakfast, t=90 minutes: yoghurt, t=210 minutes: ad libitum food intake	2 hours after yoghurt snack

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satiety feelings	Every 15-30 min, 5 attributes will be measured on a Visual Analogue Scale	Up to 3.5 hours on each of the 2 test days.
occurrence and severity of GI symptoms	Every 15-30 min, 4 attributes will be measured on a Visual Analogue Scale	Up to 3.5 hours on each of the 2 test days.

Collaborators and Investigators

• Sponsor: Maastricht University Medical Center
• Collaborators: Wageningen University and Research
• Investigators: Principal Investigator: Adrian AM Masclee, Prof., azM/UM

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 24, 2017
• Primary Completion (ACTUAL): March 31, 2017
• Study Completion (ACTUAL): March 31, 2017

Study Registration Dates

• First Submitted: January 6, 2017
• First Submitted That Met QC Criteria: January 19, 2017
• First Posted (ESTIMATE): January 20, 2017

Study Record Updates

• Last Update Posted (ACTUAL): November 20, 2017
• Last Update Submitted That Met QC Criteria: November 16, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: NL59245.068.16; 163042 (OTHER: METC)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No