NCT02615444

Brief Summary

The purpose of this study is to determine whether daily consumption of soluble fibre, oat beta glucan (4g), for six weeks will have any impact on overweight/obese individuals in terms of risk factors used to define metabolic disease.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2015

Geographic Reach
1 country

1 active site

Status
unknown

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, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 5, 2015

Completed
21 days until next milestone

First Posted

Study publicly available on registry

November 26, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

September 27, 2016

Status Verified

September 1, 2016

Enrollment Period

1.2 years

First QC Date

November 5, 2015

Last Update Submit

September 26, 2016

Conditions

Metabolic Syndrome XCardiovascular Diseases

Keywords

Metabolic Syndrome XOverweightWaist CircumferenceBlood PressureCholesterolOat beta glucan

Outcome Measures

Primary Outcomes (1)

  • Waist Circumference

    6 weeks

Secondary Outcomes (7)

  • Blood Pressure

    6 Weeks

  • Fasting Serum Triglycerides

    6 weeks

  • Oral Glucose Tolerance Test

    6 weeks

  • Fasting Serum HDL Cholesterol

    6 Weeks

  • Fasting Serum total Cholesterol

    6 weeks

  • +2 more secondary outcomes

Study Arms (2)

Beta-glucan enriched oatcake

EXPERIMENTAL

Oatcakes which have been enriched with beta-glucan. Each participant will consume 5 oatcakes daily in order to ingest 4g of oat-beta glucan.

Dietary Supplement: Beta-glucan enriched oatcake

Isocaloric control

PLACEBO COMPARATOR

Control: Wheat based snack, equicaloric and matched to intervention product for macronutrient content. Contains no oat-beta glucan. Each participant will consume 6.5 Krackawheats daily.

Dietary Supplement: Isocaloric control

Interventions

Beta-glucan enriched oatcakeDIETARY_SUPPLEMENT

5 oatcakes enriched with oat beta-glucan will be consumed daily for six weeks

Beta-glucan enriched oatcake
Isocaloric controlDIETARY_SUPPLEMENT

6.5 wheat based control snacks without beta-glucan will be consumed daily for six weeks

Isocaloric control

Eligibility Criteria

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

You may qualify if:

  • Males and females 18 years and older
  • Waist circumference measurements of ≥94cm for males and 80cm for females, or a body mass index of ≥30kg/m2
  • Individuals who are able to provide informed consent

You may not qualify if:

  • Postmenopausal females
  • Smokers
  • Individuals who suffer from, or taking medication for, cardiovascular or gastro-intestinal disease
  • Impaired glucose tolerance/Diabetes mellitus
  • Pregnancy or breastfeeding
  • Those who have high dietary fibre intakes (\>20g/day)
  • Known food allergies to oats, wheat, lactose, or sesame seeds

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen Margaret University, Edinburgh

Musselburgh, East Lothain, EH21 6UU, United Kingdom

Location

Related Publications (4)

  • Pouliot MC, Despres JP, Lemieux S, Moorjani S, Bouchard C, Tremblay A, Nadeau A, Lupien PJ. Waist circumference and abdominal sagittal diameter: best simple anthropometric indexes of abdominal visceral adipose tissue accumulation and related cardiovascular risk in men and women. Am J Cardiol. 1994 Mar 1;73(7):460-8. doi: 10.1016/0002-9149(94)90676-9.

    PMID: 8141087BACKGROUND

  • Lissner L, Lindroos AK, Sjostrom L. Swedish obese subjects (SOS): an obesity intervention study with a nutritional perspective. Eur J Clin Nutr. 1998 May;52(5):316-22. doi: 10.1038/sj.ejcn.1600567.

    PMID: 9630380BACKGROUND

  • Howarth NC, Saltzman E, Roberts SB. Dietary fiber and weight regulation. Nutr Rev. 2001 May;59(5):129-39. doi: 10.1111/j.1753-4887.2001.tb07001.x.

    PMID: 11396693BACKGROUND

  • Liatis S, Tsapogas P, Chala E, Dimosthenopoulos C, Kyriakopoulos K, Kapantais E, Katsilambros N. The consumption of bread enriched with betaglucan reduces LDL-cholesterol and improves insulin resistance in patients with type 2 diabetes. Diabetes Metab. 2009 Apr;35(2):115-20. doi: 10.1016/j.diabet.2008.09.004. Epub 2009 Feb 20.

    PMID: 19230737BACKGROUND

MeSH Terms

Conditions

Metabolic SyndromeCardiovascular DiseasesOverweight

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Suzanne Zaremba

    Queen Margaret University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Student

Study Record Dates

First Submitted

November 5, 2015

First Posted

November 26, 2015

Study Start

October 1, 2015

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

September 27, 2016

Record last verified: 2016-09

Locations

GB(1)