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

November 24, 2016 updated by: VTT Technical Research Centre of Finland
This study examines if there are differences in satiety responses between structurally different wholegrain rye products.

Study Overview

Status

Completed

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Espoo, Finland
        • Aalto University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Extruded wholegrain rye flakes
Rye products with varying structures
The satiating effect of rye products with various structures will be studied
Active Comparator: Extruded wholegrain rye puffs
Rye products with varying structures
The satiating effect of rye products with various structures will be studied
Active Comparator: Fresh wholegrain rye bread
Rye products with varying structures
The satiating effect of rye products with various structures will be studied
Active Comparator: Wholegrain rye beverage
Rye products with varying structures
The satiating effect of rye products with various structures will be studied
Active Comparator: Fresh wheat bread
Rye products with varying structures
The satiating effect of rye products with various structures will be studied

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
In every 30 min until 210 min after consumption

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

September 17, 2015

First Submitted That Met QC Criteria

September 17, 2015

First Posted (Estimate)

September 18, 2015

Study Record Updates

Last Update Posted (Estimate)

November 28, 2016

Last Update Submitted That Met QC Criteria

November 24, 2016

Last Verified

December 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • Chewy

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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