NCT02814357

Brief Summary

Double-blind, randomized, controlled, cross-over design with 3 test products and one control product. To evaluate the effect of 4 different flour compositions (guar gum 2% and 4%, chickpea flour 15% and barley flour 2% and 5%) of selected fibres and flours, on post-prandial plasma (PPG) and serum insulin levels in healthy Indian subjects, after the consumption of flat bread made from 100 gram of flour compositions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Jul 2011

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

July 1, 2011

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
5 years until next milestone

First Submitted

Initial submission to the registry

June 23, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 27, 2016

Completed
Last Updated

July 19, 2016

Status Verified

July 1, 2016

Enrollment Period

Same day

First QC Date

June 23, 2016

Last Update Submit

July 18, 2016

Conditions

Healthy

Keywords

Blood glucose, serum insulin

Outcome Measures

Primary Outcomes (1)

  • Positive incremental area under blood glucose curve

    0-120 minutes

Secondary Outcomes (1)

  • Total area under the serum insulin curve

    0-120 minutes

Other Outcomes (7)

  • Cmax glucose

    0-120 minutes

  • Tmax glucose

    0-120 minutes

  • Slope to Cmax

    0-120 minutes

  • +4 more other outcomes

Study Arms (4)

Control (market standard)

PLACEBO COMPARATOR

100 g wheat flour (atta)

Other: Control (market standard)

High fibre 1

ACTIVE COMPARATOR

81% wheat flour (atta) + 15% chickpea + 4% guar gum

Other: wheat flourOther: chickpea flourOther: guar gum

High fibre 2

ACTIVE COMPARATOR

80% wheat flour (atta) + 15% chickpea + 2% guar gum + 3% barley

Other: wheat flourOther: chickpea flourOther: guar gumOther: barley

High fibre 3

ACTIVE COMPARATOR

77% wheat flour (atta) + 15% chickpea + 3% guar gum + 5% barley

Other: wheat flourOther: chickpea flourOther: guar gumOther: barley

Interventions

Control (market standard)OTHER
Control (market standard)
wheat flourOTHER
High fibre 1High fibre 2High fibre 3
chickpea flourOTHER
High fibre 1High fibre 2High fibre 3
guar gumOTHER
High fibre 1High fibre 2High fibre 3
barleyOTHER
High fibre 2High fibre 3

Eligibility Criteria

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

You may qualify if:

  • Healthy male and female subjects between \> 20 and \< 50 years of age
  • BMI of \>18 and \< 23 kg/m2
  • Fasting blood glucose value of volunteer is \> 3.4 and \<6.1 mmol/litre (i.e. 62- 110 mg/dl) at screening

You may not qualify if:

  • Chronic smokers, tobacco chewers and drinkers.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lambda Therapeutics Research Ltd (LTRL)

Ahmedabad, Near Gujrat High Court, SG Highway, Gota, 380 061 Gujrat, India

Location

MeSH Terms

Interventions

Flourguar gum

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Rakesh Patel, Dr.

    Lambda Therapeutic Research Ltd.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2016

First Posted

June 27, 2016

Study Start

July 1, 2011

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

July 19, 2016

Record last verified: 2016-07

Locations

IN(1)