Lipid Encapsulation for Ileal Brake Activation

Maastricht University Medical Centre (MUMC)

Status: Completed

Conditions: Appetite Regulation

Treatments: Dietary Supplement: Active yoghurt; Dietary Supplement: Placebo yoghurt

Study type: Interventional

Funder types: Other

Identifiers

NCT03025997

163042 (Other Identifier)

NL59245.068.16

Details and patient eligibility

About

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.

Enrollment: 33 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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33 participants in 2 patient groups, including a placebo group

Active yoghurt

Active Comparator group

Description:

Yoghurt snack containing encapsulated lipid

Treatment:

Dietary Supplement: Active yoghurt

Placebo yoghurt

Placebo Comparator group

Description:

Yoghurt snack containing non-encapsulated lipid + empty encapsulation matrix

Treatment:

Dietary Supplement: Placebo yoghurt