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
|Condition or disease||Intervention/treatment||Phase|
|Obesity||Dietary Supplement: Oatwell28 Oatwell Original Powder Dietary Supplement: Control Breakfast||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||36 participants|
|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|
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
- 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.
- 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
- 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.
- Variation in insulin [ Time Frame: 0, 30, 60, 90 minutes ]Measure plasma insulin (pg/mL) area under the curve (AUC) over time.
- Variation in glucose [ Time Frame: 0, 30, 60, 90, 120 minutes ]Measure blood glucose (mmol/L) area under the curve (AUC) over time.
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
|Queen Margaret University, Edinburgh|
|Musselburgh, East Lothain, United Kingdom, EH21 6UU|
|Principal Investigator:||Suzanne Zaremba||Queen Margaret University|