Effects of Beta-glucan on Energy Intake and Satiety

NCT02637388 | Unknown

• 1 other identifier: QueenMUsz2
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Variation in energy intakes

  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.

  1 day

Secondary Outcomes (4)

• Variation in the feelings of appetite

  -30, 0, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150 minutes

• Variation in GLP-1

  0, 30, 60, 90 minutes

• Variation in insulin

  0, 30, 60, 90 minutes

• Variation in glucose

  0, 30, 60, 90, 120 minutes

Study Arms (2)

Placebo Comparator: Control Breakfast

PLACEBO COMPARATOR

Breakfast cereal and yoghurt only (placebo, negative control)

Dietary Supplement: Control Breakfast

Experimental: beta-Glucan Breakfast

EXPERIMENTAL

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

Dietary Supplement: Oatwell28 Oatwell Original Powder

Interventions

Oatwell28 Oatwell Original Powder DIETARY_SUPPLEMENT

Experimental: beta-Glucan Breakfast

Control Breakfast DIETARY_SUPPLEMENT

Isocaloric breakfast without added beta-glucans

Placebo Comparator: Control Breakfast

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Queen Margaret University: lead
• DSM Nutritional Products, Inc.: collaborator

Study Sites (1)

Queen Margaret University, Edinburgh

Musselburgh, East Lothain, EH21 6UU, United Kingdom

Location

Related Publications (7)

• 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.

  PMID: 22057424 BACKGROUND

• 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.

  PMID: 20679146 BACKGROUND

• 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.

  PMID: 19631705 BACKGROUND

• 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.

  PMID: 20605427 BACKGROUND

• 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.

  PMID: 21688388 BACKGROUND

• 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.

  PMID: 26315842 BACKGROUND

• 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.

  PMID: 24965303 BACKGROUND

MeSH Terms

Conditions

Obesity; Insulin Resistance

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Study Officials

• Suzanne Zaremba

  Queen Margaret University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: December 11, 2015
• First Posted: December 22, 2015
• Study Start: March 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: September 27, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)