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Effects of Beta-glucan on Energy Intake and Satiety

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ClinicalTrials.gov Identifier: NCT02637388
Recruitment Status : Unknown
Verified September 2016 by Suzanne Zaremba, Queen Margaret University.
Recruitment status was:  Enrolling by invitation
First Posted : December 22, 2015
Last Update Posted : September 27, 2016
Sponsor:
Collaborator:
DSM Nutritional Products, Inc.
Information provided by (Responsible Party):
Suzanne Zaremba, Queen Margaret University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Obesity Dietary Supplement: Oatwell28 Oatwell Original Powder Dietary Supplement: Control Breakfast Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: 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.
Study Start Date : March 2016
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. Variation in insulin [ Time Frame: 0, 30, 60, 90 minutes ]
    Measure plasma insulin (pg/mL) area under the curve (AUC) over time.

  4. Variation in glucose [ Time Frame: 0, 30, 60, 90, 120 minutes ]
    Measure blood glucose (mmol/L) area under the curve (AUC) over time.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02637388


Locations
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United Kingdom
Queen Margaret University, Edinburgh
Musselburgh, East Lothain, United Kingdom, EH21 6UU
Sponsors and Collaborators
Queen Margaret University
DSM Nutritional Products, Inc.
Investigators
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Principal Investigator: Suzanne Zaremba Queen Margaret University
Publications:

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Responsible Party: Suzanne Zaremba, Principle Investigator, Queen Margaret University
ClinicalTrials.gov Identifier: NCT02637388    
Other Study ID Numbers: QueenMUsz2
First Posted: December 22, 2015    Key Record Dates
Last Update Posted: September 27, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Suzanne Zaremba, Queen Margaret University:
Appetite
Beta-glucans
Energy Intake
Glucagon-Like Peptide 1
Glucose
Insulin
Incretins