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Effects of Beta-glucan on Energy Intake and Satiety

Q

Queen Margaret University

Status

Unknown

Conditions

Obesity

Treatments

Dietary Supplement: Control Breakfast
Dietary Supplement: Oatwell28 Oatwell Original Powder

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT02637388
QueenMUsz2

Details and patient eligibility

About

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.

Full 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.

Enrollment

36 estimated patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

36 participants in 2 patient groups, including a placebo group

Placebo Comparator: Control Breakfast
Placebo Comparator group
Description:
Breakfast cereal and yoghurt only (placebo, negative control)
Treatment:
Dietary Supplement: Control Breakfast
Experimental: beta-Glucan Breakfast
Experimental group
Description:
Breakfast cereal and yoghurt with the addition of 4g beta-glucan (14.7g Oatwell28 powder)
Treatment:
Dietary Supplement: Oatwell28 Oatwell Original Powder

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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