Clinical trial NCT02554162: Chewy Satiety - the Interplay Between Food Structure, Oral Processing and Satiety
Official title: Chewy Satiety - the Interplay Between Food Structure, Oral Processing and Satiety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Subjective Appetite and Satiety
Keywords: Satiety, appetite, wholegrain rye
Lead sponsor: VTT Technical Research Centre of Finland
Sponsor class: OTHER
Collaborators: name: University of Eastern Finland
First posted: 2015-09-18
Enrollment: 20
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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

Detailed description: 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.

Eligibility criteria: 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))

Primary outcomes:
measure: Postprandial satiety, assessed using 10 cm visual analogue scale (0=not at all, 10=Extremely)
timeFrame: In every 30 min until 210 min after consumption
Secondary outcomes:
Other outcomes:
Locations:
city: Espoo
country: Finland
facility: Aalto University
Study officials:
References: