Effects of Beta-glucan on Energy Intake and Satiety

September 26, 2016 updated by: Suzanne Zaremba, Queen Margaret University

The Effect of a Breakfast Meal Containing 4g Oat Beta-glucan on Perceived Satiety and ad Libitum Food Intake in Normal-weight and Overweight Subjects. A Double-blinded, Randomized, Placebo-controlled Cross-over Study.

The purpose of this study is to address the effect of consuming 4g of soluble fibre beta-glucan at breakfast on satiety and food intake.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Satiation and satiety are part of the body's complex appetite control system that ultimately play a role in limiting energy intake. Satiation is referred to as the process that leads to the termination of eating, which may be accompanied by feelings of satisfaction. Satiety is the feeling of fullness that persists after eating, with the potential to suppress further energy intake until hunger returns. There is evidence to suggest that increasing gastro-intestinal viscosity improves appetite control and reduces subsequent food intake. Beta-glucan is a soluble fibre proposed to behave this way.

In this double-blinded, randomized, crossover trial, subjective appetite sensations will be measured and blood will be collected at specific time points during the two arms in order to determine hormonal responses. Ad libitum food intake will be recorded. Food diaries will be used to measure dietary intakes.

Study Type

Interventional

Enrollment (Anticipated)

36

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

  • United Kingdom
    • East Lothain
      • Musselburgh, East Lothain, United Kingdom, EH21 6UU
        • Queen Margaret University, Edinburgh

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

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Males or Females, aged 18-50 years
  • BMI of 20.0 - 29.9 kg/m2 at screening
  • Subjects who usually consume breakfast
  • Subject is willing to stick to his/her normal habitual diet, excluding the consumption of any unusual high energy-rich or fat-rich meals or undergo periods of fasting during the study period.
  • Subject is willing to abstain from strenuous exercise, consume alcoholic drinks and caffeine containing food/drinks 24hours before study days and during study days.
  • Ability to pass the Dutch Eating Behaviour Questionnaire (Van Strein et al. 1986) to measure dietary restraint, disinhibition and hunger
  • Subjects understands the study procedures and signs the informed consent to participate in the study
  • Subject has no health conditions that would prevent him/her from fulfilling the study requirements as judged by the investigator on the basis of medical history or parameters measured during screening.
  • Subject has been stable in body-weight within the last 6 months.
  • Female subjects are willing to use a contraceptive method to avoid pregnancy during the study period.

Exclusion Criteria:

  • Postmenopausal females
  • Smokers
  • Individuals who suffer from (or taking medication for) cardiovascular disease or gastrointestinal disease, including hypertension, hypercholesterolemia, hyperlipidaemia, Crohn's Disease, Irritable bowel syndrome, etc.
  • Impaired glucose tolerance/Diabetes mellitus (Fasting blood glucose of ≥5.6mmol/l or 100mg/dL as per NHS criteria)
  • Haemoglobin measurements of <120g/L for females and <130g/L for males (as per WHO criteria for anaemia)
  • Pregnancy or breastfeeding
  • Those who consume a high fibre diet - consumption of more than 20g/day - Individuals who have known food allergies to ingredients used in study meals (wheat, cow's milk, ham, dairy)
  • Needle phobia
  • Subjects who are on hypocaloric/hypercaloric diet aiming for weight loss/gain.
  • Recent history of (within 12 months of screening visit) or strong potential for alcohol or substance abuse. Alcohol abuse is defined as >60g (men) / 40g (women) pure alcohol per day (1.5 l / 1 l beer resp. 0.75 l / 0.5 l wine).
  • Subject has donated more than 300 mL of blood during the three months prior to screening.

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo Comparator: Control Breakfast
Breakfast cereal and yoghurt only (placebo, negative control)
Dietary supplement: Control Breakfast
Isocaloric breakfast without added beta-glucans
Experimental: Experimental: beta-Glucan Breakfast
Breakfast cereal and yoghurt with the addition of 4g beta-glucan (14.7g Oatwell28 powder)
Dietary supplement: Oatwell28 Oatwell Original Powder

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Variation in energy intakes
Time Frame: 1 day
Ad libitum food intake (kilocalories) will be determined during an 'all you can' eat buffet lunch. Food intakes will be measured over 5 days; 3 days prior to the study day, on the day of the study and the day after.
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Variation in the feelings of appetite
Time Frame: -30, 0, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150 minutes
Measure of the satiating effect for each breakfast with Visual Analog Scale (Area Under the Curve) over time for subjective appetite parameters
-30, 0, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150 minutes
Variation in GLP-1
Time Frame: 0, 30, 60, 90 minutes
Measure plasma total glucagon-like peptide 1 (GLP-1) area under the curve (AUC) over time.
0, 30, 60, 90 minutes
Variation in insulin
Time Frame: 0, 30, 60, 90 minutes
Measure plasma insulin (pg/mL) area under the curve (AUC) over time.
0, 30, 60, 90 minutes
Variation in glucose
Time Frame: 0, 30, 60, 90, 120 minutes
Measure blood glucose (mmol/L) area under the curve (AUC) over time.
0, 30, 60, 90, 120 minutes

Collaborators and Investigators

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

Sponsor

Queen Margaret University

Collaborators

DSM Nutritional Products, Inc.

Investigators

  • Principal Investigator: Suzanne Zaremba, Queen Margaret University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

March 1, 2016

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

December 11, 2015

First Submitted That Met QC Criteria

December 17, 2015

First Posted (Estimate)

December 22, 2015

Study Record Updates

Last Update Posted (Estimate)

September 27, 2016

Last Update Submitted That Met QC Criteria

September 26, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • QueenMUsz2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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