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Effects of Beta-glucan on Energy Intake and Satiety

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.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02637388
Enrollment
36
Registered
2015-12-22
Start date
2016-03-31
Completion date
2016-12-31
Last updated
2016-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

Appetite, Beta-glucans, Energy Intake, Glucagon-Like Peptide 1, Glucose, Insulin, Incretins

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.

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.

Interventions

DIETARY_SUPPLEMENTOatwell28 Oatwell Original Powder
DIETARY_SUPPLEMENTControl Breakfast

Isocaloric breakfast without added beta-glucans

Sponsors

DSM Nutritional Products, Inc.
CollaboratorINDUSTRY
Queen Margaret University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Variation in energy intakes1 dayAd 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

MeasureTime frameDescription
Variation in the feelings of appetite-30, 0, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150 minutesMeasure of the satiating effect for each breakfast with Visual Analog Scale (Area Under the Curve) over time for subjective appetite parameters
Variation in GLP-10, 30, 60, 90 minutesMeasure plasma total glucagon-like peptide 1 (GLP-1) area under the curve (AUC) over time.
Variation in insulin0, 30, 60, 90 minutesMeasure plasma insulin (pg/mL) area under the curve (AUC) over time.
Variation in glucose0, 30, 60, 90, 120 minutesMeasure blood glucose (mmol/L) area under the curve (AUC) over time.

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026