NCT03293693

Brief Summary

The overall aim is to investigate the intake of beta-glucan in relation to glucose metabolism and satiety in a postprandial study with healthy subjects. The potential effects will be related to changes in the gut microbiota, the circulating levels of short chain fatty acids, inflammation and gene expression in peripheral mononuclear blood cells

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 10, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
4 months until next milestone

First Posted

Study publicly available on registry

September 26, 2017

Completed
Last Updated

September 26, 2017

Status Verified

September 1, 2017

Enrollment Period

8 months

First QC Date

March 10, 2017

Last Update Submit

September 25, 2017

Conditions

Post Prandial Blood GlucoseGut MicrobiotaSatiety

Keywords

beta-glucanBlood glucoseGut microbiotaSatietyDietary intervention

Outcome Measures

Primary Outcomes (2)

  • Postprandial blood glucose response

    Blood glucose response after OGTT

    At day 4

  • Postprandial insulin response

    insulin response after OGTT

    At day 4

Secondary Outcomes (12)

  • H2 breath response

    At day 4

  • Free fatty acids

    At day 4

  • Microbiota analyses in feces

    At day 4

  • Serum triglyceride response

    At day 4

  • Serum cholesterol

    At day 4

  • +7 more secondary outcomes

Study Arms (3)

Test meal 1

EXPERIMENTAL

Test meal with 0.5 g beta-glucan

Other: 0.5 g beta-glucan

Test meal 2

EXPERIMENTAL

Test meal with 3.5 g beta-glucan

Other: 3.5 g beta-glucan

Test meal 3

EXPERIMENTAL

Test meal with 8 g beta-glucan

Other: 8 g beta-glucan

Interventions

0.5 g beta-glucanOTHER

Dietary cross-over study with beta-glucan fiber

Test meal 1
3.5 g beta-glucanOTHER

Dietary cross-over study with beta-glucan fiber

Test meal 2
8 g beta-glucanOTHER

Dietary cross-over study with beta-glucan fiber

Test meal 3

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI between 18,5 and 27 kg/m2
  • Fasting plasma glucose ≤ 6.1 mmol/l

You may not qualify if:

  • Chronic metabolic diseases such as diabetes type 1 and 2, coronary heart disease and cancer the last 6 months.
  • Intestinal diseases such as chrons disease, ulcerative colitis and irritable bowel syndrome.
  • Food allergy and intolerances towards grain and dairy products.
  • Pregnant and lactating
  • Smokers
  • Fasting blood glucose ≥ 6.1 mmol/L
  • CRP \> 10 mg/L, measured at baseline (visit 0)
  • BMI \<18,5 and \>27 kg/m2
  • Planned weight reduction and or ± 5% weight change over the past three months.
  • Use of antibiotics last 3 months before study entry and during the study period
  • Use of probiotics the last month before study entry and during the study period
  • Blood donor last 2 months before study entry and or during the study period
  • Not willing to end the use of dietary supplements four weeks prior to study entry and throughout the study period
  • Alcohol consumption \> 40g / day
  • Hormone treatments (except contraceptives)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo and Akershus university College

Oslo, 0130, Norway

Location

Related Publications (1)

  • Telle-Hansen VH, Gaundal L, Hogvard B, Ulven SM, Holven KB, Byfuglien MG, Mage I, Knutsen SH, Ballance S, Rieder A, Rud I, Myhrstad MCW. A Three-Day Intervention With Granola Containing Cereal Beta-Glucan Improves Glycemic Response and Changes the Gut Microbiota in Healthy Individuals: A Crossover Study. Front Nutr. 2022 Apr 28;9:796362. doi: 10.3389/fnut.2022.796362. eCollection 2022.

    PMID: 35578615DERIVED

MeSH Terms

Interventions

beta-Glucans

Intervention Hierarchy (Ancestors)

GlucansPolysaccharidesCarbohydrates

Study Officials

  • Mari CW Myhrstad, PhD

    Oslo and Akershus University College

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: Intervention With cross-over design. Three test meals will be tested.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2017

First Posted

September 26, 2017

Study Start

October 1, 2016

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

September 26, 2017

Record last verified: 2017-09

Locations

NO(1)