NCT00877968

Brief Summary

The objective of this study was to determine if whole yellow pea flour reduces post-prandial glycemic responses of novel food products. The second objective was to determine if whole yellow pea flour produces food products with favorable sensory characteristics including appearance, taste, smell, texture and overall acceptability, compared to corresponding food products made with whole wheat flour.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for phase_2 diabetes

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

March 1, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

April 7, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 8, 2009

Completed
Last Updated

April 8, 2009

Status Verified

April 1, 2009

Enrollment Period

2 months

First QC Date

April 7, 2009

Last Update Submit

April 7, 2009

Conditions

Diabetes

Keywords

Pea flourGlycemic responseDiabetesSensoryFunctional foodDiabetes control and prevention

Outcome Measures

Primary Outcomes (1)

  • Post-prandial glycemic response

Secondary Outcomes (2)

  • Comparison of hedonic sensory characteristics between corresponding food products

  • Appearance, taste, texture, smell and overall acceptability

Study Arms (8)

Whole wheat banana bread

PLACEBO COMPARATOR

Banana bread made with whole wheat flour

Dietary Supplement: Whole wheat banana bread

Whole pea flour banana bread

ACTIVE COMPARATOR

Banana bread made with whole pea flour

Dietary Supplement: Whole pea flour banana bread

Whole wheat biscotti

PLACEBO COMPARATOR

Biscotti made with whole wheat flour

Dietary Supplement: Whole wheat biscotti

Whole pea biscotti

ACTIVE COMPARATOR

Biscotti made with whole pea flour

Dietary Supplement: Whole pea flour biscotti

Whole wheat pasta

PLACEBO COMPARATOR

Pasta made with whole wheat durum

Dietary Supplement: Whole wheat pasta

Whole pea flour

ACTIVE COMPARATOR

Pasta made with 30% whole pea flour and 70% white wheat durum

Dietary Supplement: Whole pea pasta

White bread

PLACEBO COMPARATOR
Dietary Supplement: White bread

Boiled yellow peas

PLACEBO COMPARATOR
Dietary Supplement: Boiled yellow peas

Interventions

Whole wheat banana breadDIETARY_SUPPLEMENT

Dose was portioned so that subjects received 50 g available carbohydrate Portion: 62.8 g Available CHO: 51.7 g

Whole wheat banana bread
Whole pea flour banana breadDIETARY_SUPPLEMENT

Dose was portioned so that subjects received 50 g available carbohydrate Portion: 67.8 g Available CHO: 52.0 g

Whole pea flour banana bread
Whole wheat biscottiDIETARY_SUPPLEMENT

Dose was portioned so that subjects received 50 g available carbohydrate Portion: 79.8 g Available CHO: 53.1 g

Whole wheat biscotti
Whole pea flour biscottiDIETARY_SUPPLEMENT

Dose was portioned so that subjects received 50 g available carbohydrate Portion: 86 g Available CHO: 51.7 g

Whole pea biscotti
Whole wheat pastaDIETARY_SUPPLEMENT

Dose was portioned so that subjects received 50 g available carbohydrate Portion (Dry): 70 g Available CHO: 51.1 g

Whole wheat pasta
Whole pea pastaDIETARY_SUPPLEMENT

Dose was portioned so that subjects received 50 g available carbohydrate Pea pasta is 30% whole pea pasta, 70 white wheat durum Portion (Dry pasta) : 90 g Available CHO: 53.1 g

Whole pea flour
White breadDIETARY_SUPPLEMENT

Dose was portioned so that subjects received 50 g available carbohydrate Portion: 100 g Available CHO: 50 g

White bread
Boiled yellow peasDIETARY_SUPPLEMENT

Dose was portioned so that subjects received 50 g available carbohydrate Portion: 100 g (dry) --\> 250 g cooked Available CHO: 52.8 g

Boiled yellow peas

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy men
  • non-lactating women
  • BMI's between 18 and 31 kg/m2

You may not qualify if:

  • heart disease
  • diabetes
  • thyroid disease
  • celiac disease
  • gluten intolerance
  • taking corticosteroid medications
  • smokers
  • Chronic alcohol usage (\> 2 drinks/d)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Richardson Centre for Functional Foods and Nutraceuticals

Winnipeg, Manitoba, R3T 2N2, Canada

Location

Related Publications (1)

  • Marinangeli CP, Kassis AN, Jones PJ. Glycemic responses and sensory characteristics of whole yellow pea flour added to novel functional foods. J Food Sci. 2009 Nov-Dec;74(9):S385-9. doi: 10.1111/j.1750-3841.2009.01347.x.

    PMID: 20492127DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Peter JH Jones, PhD

    University of Manitoba

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 7, 2009

First Posted

April 8, 2009

Study Start

March 1, 2008

Primary Completion

May 1, 2008

Last Updated

April 8, 2009

Record last verified: 2009-04

Locations

CA(1)