Lipid Encapsulation for Ileal Brake Activation

Appetite Regulation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03025997
• Other study ID #: NL59245.068.16
• Secondary ID: 163042
• Status: Completed
• Phase: N/A
• First received: January 6, 2017
• Last updated: November 16, 2017
• Start date: January 24, 2017
• Est. completion date: March 31, 2017

Study information

• Verified date: March 2017
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: March 31, 2017
• Est. primary completion date: March 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Appetite Regulation

Intervention

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

Locations

Country	Name	City	State
Netherlands	Maastricht University	Maastricht

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht University Medical Center	Wageningen University and Research Centre

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.