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Completed

NCT Number: NCT02554162

Chewy Satiety - the Interplay Between Food Structure, Oral Processing and Satiety

This study examines if there are differences in satiety responses between structurally different wholegrain rye products.

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Key information

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Aalto University

Espoo, Finland

About this study

The study consists of a satiety trial and mastication trial. The satiety trial consists of five study visits. Five cereal products with berry soup are presented in random order for each subject serving one of them in each study visit (crossover study design). Each meal consists of rye product or wheat bread providing 190 kcal of energy and of 3 dl berry soup (3 dl) providing 140 kcal of energy. The participants are instructed to evaluate their satiety and related sensations before eating the test food, right after eating and then every 30 min until 210 min after breakfast consumption. The evaluated sensations are hunger, fullness, satiety, desire to eat and prospective food consumption ("How much would you be able to eat right now?"), "thirstiness", "mood", "vigourosness" and "pleasantness"."Pleasantness" will be evaluated only right after eating the test food.

Cereal food samples with 3-digit number codes will be offered to each participant in a random order in mastication trial. The study products are rye products with varying structures. First the participant is asked to evaluate the expected satiety of the product (How filling would you expect this portion to be on a scale from 0 (=not full at all) to 10 (=extremely full)). Secondly the same food will be served to the participant in three portions and the participant will be asked to masticate each portion until she considers it to be ready for swallowing. Instead of swallowing the bolus will be expectorated to a plastic container which is kept on ice. The mastication process is characterized by measuring electrical activity of facial muscles by electromyography (EMG). The mastication process will be video-recorded to support data handling.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • BMI 18.5-25 kg/m2
  • Habit of eating breakfast

Exclusion criteria

  • Significant changes in body weight (+ or - 4 kg) during the previous year
  • Smoking
  • Pregnant or lactating
  • Missing teeth (except 3rd molars)
  • Acute temporomandibular disorders (TMD)
  • Dietary restrictions possibly affecting the study (celiac disease, allergies or aversions to cereal foods/high carbohydrate foods)
  • Abnormal eating behaviour (according to EDDS (Eating Disorder Diagnostic Scale))

Treatment and study plan

Rye products with varying structures

Other

The satiating effect of rye products with various structures will be studied

Primary outcomes

  1. Postprandial satiety, assessed using 10 cm visual analogue scale (0=not at all, 10=Extremely)

    Time frame: In every 30 min until 210 min after consumption

Sponsors and collaborators

Lead sponsor

VTT Technical Research Centre of Finland

Other

Collaborators

  • University of Eastern Finland

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Sep 18, 2015
Registry last updated
Nov 28, 2016

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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