Effects of Beta-glucan on Energy Intake and Satiety

Sponsor

Queen Margaret University (Other)

Overall Status

Unknown status

CT.gov ID

NCT02637388

Collaborator

DSM Nutritional Products, Inc. (Industry)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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 Design

Study Type:

Interventional

Anticipated 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 :

Mar 1, 2016

Anticipated Primary Completion Date :

Dec 1, 2016

Anticipated Study Completion Date :

Dec 1, 2016

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Variation in energy intakes [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

Variation in the feelings of appetite [-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 [0, 30, 60, 90 minutes]
Measure plasma total glucagon-like peptide 1 (GLP-1) area under the curve (AUC) over time.
Variation in insulin [0, 30, 60, 90 minutes]
Measure plasma insulin (pg/mL) area under the curve (AUC) over time.
Variation in glucose [0, 30, 60, 90, 120 minutes]
Measure blood glucose (mmol/L) area under the curve (AUC) over time.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.