Lipid Encapsulation for Ileal Brake Activation

Not Applicable

Completed

• Conditions: Appetite Regulation
• Interventions: Dietary Supplement: Active yoghurt; Dietary Supplement: Placebo yoghurt

• Registration Number: NCT03025997
• Lead Sponsor: Maastricht University Medical Center

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2017-01-06
• Study First Submitted QC: 2017-01-19
• Study First Posted: 2017-01-20
• Study Start: 2017-01-24
• Status Verified: 2017-03
• Primary Completion: 2017-03-31
• Study Completion: 2017-03-31
• Last Update Submitted: 2017-11-16
• Last Update Posted: 2017-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Active yoghurt	Active yoghurt	Yoghurt snack containing encapsulated lipid
Placebo yoghurt	Placebo yoghurt	Yoghurt snack containing non-encapsulated lipid + empty encapsulation matrix

Primary Outcome Measures

Name	Time	Method
ad libitum food intake	2 hours after yoghurt snack	t=0: standardized breakfast, t=90 minutes: yoghurt, t=210 minutes: ad libitum food intake

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Maastricht University; 🇳🇱 Maastricht, Netherlands