NCT02671214

Brief Summary

Identify one or more flat bread mixes that produce a reduction in positive incremental area under the curve (iAUC) of post-prandial glucose relative to the control product.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Nov 2010

Shorter than P25 for not_applicable healthy

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

November 1, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
5.1 years until next milestone

First Submitted

Initial submission to the registry

January 28, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 2, 2016

Completed
Last Updated

February 2, 2016

Status Verified

January 1, 2016

Enrollment Period

2 months

First QC Date

January 28, 2016

Last Update Submit

February 1, 2016

Conditions

Healthy

Keywords

guar gumkonjac mannanblood glucoselegume flour

Outcome Measures

Primary Outcomes (1)

  • Positive incremental area under the curve (iAUC)

    120 minutes

Secondary Outcomes (1)

  • Positive incremental area under the curve (iAUC)

    180 minutes

Study Arms (12)

Control

PLACEBO COMPARATOR

100 g high fibre flour

Other: Control

Active 1

ACTIVE COMPARATOR

85 g high fibre flour + 15 g legume flour

Other: Active 1

Active 2

ACTIVE COMPARATOR

98 g high fibre flour + 2 g guar gum

Other: Active 2

Active 3

ACTIVE COMPARATOR

88 g high fibre flour + 2 g guar gum + 10 g legume flour

Other: Active 3

Active 4

ACTIVE COMPARATOR

83 g high fibre flour + 2 g guar gum + 15 g legume flour

Other: Active 4

Active 5

ACTIVE COMPARATOR

96 g high fibre flour + 4 g guar gum

Other: Active 5

Active 6

ACTIVE COMPARATOR

86 g high fibre flour + 4 g guar gum + 10 g legume flour

Other: Active 6

Active 7

ACTIVE COMPARATOR

81 g high fibre flour + 4 g guar gum + 15 g legume flour

Other: Active 7

Active 8

ACTIVE COMPARATOR

94 g high fibre flour + 6 g guar gum

Other: Active 8

Active 9

ACTIVE COMPARATOR

98 g high fibre flour + 2 g konjac mannan

Other: Active 9

Active 10

ACTIVE COMPARATOR

96 g high fibre flour + 4 g konjac mannan

Other: Active 10

Active 11

ACTIVE COMPARATOR

100 g low fibre flour

Other: Active 11

Interventions

ControlOTHER

100 g high fibre flour

Control
Active 2OTHER

98 g high fibre flour + 2 g guar gum

Active 2
Active 3OTHER

88 g high fibre flour + 2 g guar gum + 10 g legume flour

Active 3
Active 4OTHER

83 g high fibre flour + 2 g guar gum + 15 g legume flour

Active 4
Active 5OTHER

96 g high fibre flour + 4 g guar gum

Active 5
Active 6OTHER

86 g high fibre flour + 4 g guar gum + 10 g legume flour

Active 6
Active 7OTHER

81 g high fibre flour + 4 g guar gum + 15 g legume flour

Active 7
Active 8OTHER

94 g high fibre flour + 6 g guar gum

Active 8
Active 9OTHER

98 g high fibre flour + 2 g konjac mannan

Active 9
Active 10OTHER

96 g high fibre flour + 4 g konjac mannan

Active 10
Active 11OTHER

100 g low fibre flour

Active 11
Active 1OTHER

85 g high fibre flour + 15 g legume flour

Active 1

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Body mass index (BMI) ≥ 20 and ≤ 25.0 kg/m2.
  • Apparently healthy: no medical conditions which might affect study measurements (as judged by the study physician).
  • A fasting blood glucose value between 3.5 - 5.6 mmol/litre at screening (measured by finger prick).

You may not qualify if:

  • Use of medication which interferes with study measurements (as judged by the study physician).
  • Reported dietary habits: medically prescribed diet, slimming diet, not used to eat 3 meals a day, vegetarian.
  • Reported weight loss/gain (\>10%) in the last six month before the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Leatherhead Food Research UK

Leatherhead, Randalls Road, Surrey, KT22 7RY, United Kingdom

Location

Related Publications (1)

  • Boers HM, MacAulay K, Murray P, Seijen Ten Hoorn J, Hoogenraad AR, Peters HPF, Vente-Spreeuwenberg MAM, Mela DJ. Efficacy of different fibres and flour mixes in South-Asian flatbreads for reducing post-prandial glucose responses in healthy adults. Eur J Nutr. 2017 Sep;56(6):2049-2060. doi: 10.1007/s00394-016-1242-9. Epub 2016 Jun 21.

    PMID: 27324141DERIVED

MeSH Terms

Interventions

Bc-4 active principlepTAC5 protein, ArabidopsispTAC10 protein, Arabidopsis

Study Officials

  • Sarah Hull

    Leatherhead Food Research UK

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2016

First Posted

February 2, 2016

Study Start

November 1, 2010

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

February 2, 2016

Record last verified: 2016-01

Locations

GB(1)