NCT02294123

Brief Summary

Objective. To evaluate the effect of the intake of two types of whole corn tortilla and one traditional tortilla on glycemic index (GI) and insulinemic index (InIn) in adults with diabetes, or overweight or clinically healthy. Material and methods. Type crossover clinical trial in adults 20-69 years. Three groups of participants will be included for each category (n = 27 in each group): 1) adults with diabetes, b) adults with overweight c) clinically healthy adults. The glycemic and insulinemic index will be measure for each group of participants given in random order the following foods: 1) a whole corn tortilla (white "criollo" corn= 5.3% fiber), 2) a whole corn tortilla (white "hybrid" corn= 7.9%), 3) a traditional corn tortilla (3.9% fiber), and 4) white bread (reference food containing 2.2% of fiber). For the calculation of GI and InIn will be follow the "FAO" methodology. For the evaluation of each food left the range of 1 week.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
81

participants targeted

Target at P25-P50 for not_applicable diabetes

Timeline
Completed

Started Sep 2013

Typical duration for not_applicable 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

September 1, 2013

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

November 14, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 19, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

March 16, 2016

Status Verified

September 1, 2015

Enrollment Period

1.7 years

First QC Date

November 14, 2014

Last Update Submit

March 14, 2016

Conditions

DiabetesOverweightHealthy

Outcome Measures

Primary Outcomes (2)

  • Glycemic index

    Blood glucose concentration increase after food intakes (3 types of tortilla and white bread)

    2 hours

  • Insulinemic index

    Blood insulin concentration increase after food intakes (3 types of tortilla and white bread)

    2 hours

Study Arms (3)

Diabetes (3 tortillas and white bread)

EXPERIMENTAL

Each participants (n=27) receive in random order the following foods: 1) a whole corn tortilla (white "criollo" corn= 5.3% fiber), 2) a whole corn tortilla (white "hybrid" corn= 7.9%), 3) a traditional corn tortilla (3.9% fiber), and 4) white bread (reference food containing 2.2% of fiber).

Other: 3 tortillas and white bread

Overweight (3 tortillas and white bread)

EXPERIMENTAL

Each participants (n=27) receive in random order the following foods: 1) a whole corn tortilla (white "criollo" corn= 5.3% fiber), 2) a whole corn tortilla (white "hybrid" corn= 7.9%), 3) a traditional corn tortilla (3.9% fiber), and 4) white bread (reference food containing 2.2% of fiber).

Other: 3 tortillas and white bread

Healthy (3 tortillas and white bread)

EXPERIMENTAL

Each participants (n=27) receive in random order the following foods: 1) a whole corn tortilla (white "criollo" corn= 5.3% fiber), 2) a whole corn tortilla (white "hybrid" corn= 7.9%), 3) a traditional corn tortilla (3.9% fiber), and 4) white bread (reference food containing 2.2% of fiber).

Other: 3 tortillas and white bread

Interventions

3 tortillas and white breadOTHER

Type crossover clinical trial in adults 20-69 years. Three groups of participants were included for each category (n = 27 in each group): 1) adults with diabetes, b) adults with overweight c) clinically healthy adults. The glycemic and insulinemic index was measured for each group of participants given in random order the 3 types of Tortilla and white bread

Also known as: Glicemic index and insulinemic index
Diabetes (3 tortillas and white bread)Healthy (3 tortillas and white bread)Overweight (3 tortillas and white bread)

Eligibility Criteria

Age20 Years - 69 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • One group (n=27) with a diagnosis of type 2 diabetes documented by fasting blood glucose.
  • One group (n=27) with overweight by Body Mass Index (BMI) \>=25 kg/m2
  • One group (n=27) with healthy adults without non communicable chronic diseases

You may not qualify if:

  • Alterations associated with digestion and bariatric surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mexican National Institute of Public Health

Cuernavaca, Morelos, 62100, Mexico

Location

MeSH Terms

Conditions

Diabetes MellitusOverweight

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Simon Barquera, PhD

    Mexican Institute of Public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Policies and Programs in Nutrition

Study Record Dates

First Submitted

November 14, 2014

First Posted

November 19, 2014

Study Start

September 1, 2013

Primary Completion

June 1, 2015

Study Completion

October 1, 2015

Last Updated

March 16, 2016

Record last verified: 2015-09

Locations

ME(1)