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OpenTrials
Completed

NCT Number: NCT03025997

Lipid Encapsulation for Ileal Brake Activation

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.

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Key information

Conditions

Appetite Regulation

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maastricht University

Maastricht, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Active yoghurt

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

Dietary Supplement

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

Primary outcomes

  1. ad libitum food intake

    Time frame: 2 hours after yoghurt snack

    t=0: standardized breakfast, t=90 minutes: yoghurt, t=210 minutes: ad libitum food intake

Secondary outcomes

  1. Satiety feelings

    Time frame: 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

  2. occurrence and severity of GI symptoms

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Collaborators

  • Wageningen University and Research

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jan 20, 2017
Registry last updated
Nov 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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