Effects of Beta-glucan on Energy Intake and Satiety

NCT ID: NCT02637388

Last Updated: 2016-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2016-12-31

Brief Summary

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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

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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.

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo Comparator: Control Breakfast

Breakfast cereal and yoghurt only (placebo, negative control)

Group Type PLACEBO_COMPARATOR

Control Breakfast

Intervention Type DIETARY_SUPPLEMENT

Isocaloric breakfast without added beta-glucans

Experimental: beta-Glucan Breakfast

Breakfast cereal and yoghurt with the addition of 4g beta-glucan (14.7g Oatwell28 powder)

Group Type EXPERIMENTAL

Oatwell28 Oatwell Original Powder

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Oatwell28 Oatwell Original Powder

Intervention Type DIETARY_SUPPLEMENT

Control Breakfast

Isocaloric breakfast without added beta-glucans

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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DSM Nutritional Products, Inc.

INDUSTRY

Sponsor Role collaborator

Queen Margaret University

OTHER

Sponsor Role lead

Responsible Party

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Suzanne Zaremba

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Suzanne Zaremba

Role: PRINCIPAL_INVESTIGATOR

Queen Margaret University

Locations

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Queen Margaret University, Edinburgh

Musselburgh, East Lothain, United Kingdom

Site Status

Countries

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United Kingdom

References

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Barone Lumaga R, Azzali D, Fogliano V, Scalfi L, Vitaglione P. Sugar and dietary fibre composition influence, by different hormonal response, the satiating capacity of a fruit-based and a beta-glucan-enriched beverage. Food Funct. 2012 Jan;3(1):67-75. doi: 10.1039/c1fo10065c. Epub 2011 Nov 4.

Reference Type BACKGROUND
PMID: 22057424 (View on PubMed)

Vitaglione P, Lumaga RB, Montagnese C, Messia MC, Marconi E, Scalfi L. Satiating effect of a barley beta-glucan-enriched snack. J Am Coll Nutr. 2010 Apr;29(2):113-21. doi: 10.1080/07315724.2010.10719824.

Reference Type BACKGROUND
PMID: 20679146 (View on PubMed)

Vitaglione P, Lumaga RB, Stanzione A, Scalfi L, Fogliano V. beta-Glucan-enriched bread reduces energy intake and modifies plasma ghrelin and peptide YY concentrations in the short term. Appetite. 2009 Dec;53(3):338-44. doi: 10.1016/j.appet.2009.07.013. Epub 2009 Jul 23.

Reference Type BACKGROUND
PMID: 19631705 (View on PubMed)

Juvonen KR, Salmenkallio-Marttila M, Lyly M, Liukkonen KH, Lahteenmaki L, Laaksonen DE, Uusitupa MI, Herzig KH, Poutanen KS, Karhunen LJ. Semisolid meal enriched in oat bran decreases plasma glucose and insulin levels, but does not change gastrointestinal peptide responses or short-term appetite in healthy subjects. Nutr Metab Cardiovasc Dis. 2011 Sep;21(9):748-56. doi: 10.1016/j.numecd.2010.02.002. Epub 2010 Jun 4.

Reference Type BACKGROUND
PMID: 20605427 (View on PubMed)

Huang XF, Yu Y, Beck EJ, South T, Li Y, Batterham MJ, Tapsell LC, Chen J. Diet high in oat beta-glucan activates the gut-hypothalamic (PYY(3)(-)(3)(6)-NPY) axis and increases satiety in diet-induced obesity in mice. Mol Nutr Food Res. 2011 Jul;55(7):1118-21. doi: 10.1002/mnfr.201100095. Epub 2011 Jun 20.

Reference Type BACKGROUND
PMID: 21688388 (View on PubMed)

Steinert RE, Beglinger C, Langhans W. Intestinal GLP-1 and satiation: from man to rodents and back. Int J Obes (Lond). 2016 Feb;40(2):198-205. doi: 10.1038/ijo.2015.172. Epub 2015 Aug 28.

Reference Type BACKGROUND
PMID: 26315842 (View on PubMed)

Steinert RE, Schirra J, Meyer-Gerspach AC, Kienle P, Fischer H, Schulte F, Goeke B, Beglinger C. Effect of glucagon-like peptide-1 receptor antagonism on appetite and food intake in healthy men. Am J Clin Nutr. 2014 Aug;100(2):514-23. doi: 10.3945/ajcn.114.083246. Epub 2014 Jun 25.

Reference Type BACKGROUND
PMID: 24965303 (View on PubMed)

Other Identifiers

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QueenMUsz2

Identifier Type: -

Identifier Source: org_study_id

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