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

Subjective Appetite and Satiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02554162
• Other study ID #: Chewy
• Status: Completed
• Phase: N/A
• First received: September 17, 2015
• Last updated: November 24, 2016
• Start date: October 2015
• Est. completion date: December 2015

Study information

• Verified date: December 2015
• Source: VTT Technical Research Centre of Finland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: National Committee on Medical Research Ethics TUKIJA
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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))

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Subjective Appetite and Satiety

Intervention

Other:
• Rye products with varying structures
The satiating effect of rye products with various structures will be studied

Locations

Country	Name	City	State
Finland	Aalto University	Espoo

Sponsors (2)

Lead Sponsor	Collaborator
VTT Technical Research Centre of Finland	University of Eastern Finland

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postprandial satiety, assessed using 10 cm visual analogue scale (0=not at all, 10=Extremely)		In every 30 min until 210 min after consumption	No