Glycemic and Hormone Responses After the Intake of Four Types of Bread.

NCT02653677 | Completed

• 1 other identifier: Bo11/14
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purposes of the present study are to determine the glycemic and insulinemic responses, the satiety rate and the postprandial plasma concentrations of free fatty acids, triglycerides and satiety hormones after the ingestion of four types of breads: handcrafted bread made with wheat organic flour; handcrafted bread with wheat flour of large-scale retail distribution; handcrafted bread with organic einkorn flour and a commercial wheat bread.

Conditions

Hyperglycemia; Insulin Sensitivity

Outcome Measures

Primary Outcomes (1)

• Glucose-under-the curve (AUC) after ingestion of 4 types of bread

  Glycemic AUC is defined as the blood glucose increment over 2 hours in response to the consumption of the amount of bread providing 50 g of available carbohydrates

  0 to 120 minutes after the ingestion of each bread

Secondary Outcomes (1)

• Insulin-under-the curve (AUC) after ingestion of 4 types of bread

  0 to 120 minutes after the ingestion of each bread

Other Outcomes (2)

• Free fatty acid (FFA) AUC after the ingestion of 4 types of bread

  0 to 120 minutes after the ingestion of each bread

• Ghrelin responses after the ingestion of 4 types of bread

  0 to 120 minutes after the ingestion of each bread

Study Arms (4)

commercial bread, wheat flour

ACTIVE COMPARATOR

Intake of the specific kind of bread

Other: intake of the specific kind of bread

wheat, organic flour

EXPERIMENTAL

Intake of the specific kind of bread

Other: intake of the specific kind of bread

wheat, supermarket flour

EXPERIMENTAL

Intake of the specific kind of bread

Other: intake of the specific kind of bread

einkorn, organic flour

EXPERIMENTAL

intake of the specific kind of bread

Other: intake of the specific kind of bread

Interventions

intake of the specific kind of bread OTHER

To determine the glycemic and insulinemic responses (area-under the curve, AUCs), the satiety rate and the AUCs of free fatty acids (FFA), triglycerides and ghrelin after the ingestion of four types of breads, each containing 50g of available carbohydrates

commercial bread, wheat flour; einkorn, organic flour; wheat, organic flour; wheat, supermarket flour

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• body mass index (BMI) between 18 and 25 kg/m2
• healthy
• Accept to participate in the study

You may not qualify if:

• smokers
• subjects suffering from any diseases
• drug therapy
• dietary supplementation
• patients unable to give informed consent to participate in the study

Sponsors & Collaborators

• University of Turin, Italy: lead

MeSH Terms

Conditions

Hyperglycemia; Insulin Resistance

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hyperinsulinism

Study Officials

• Simona Bo, MD

  University of Turin, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 6, 2016
• First Posted: January 12, 2016
• Study Start: February 1, 2015
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: January 12, 2016

Record last verified: 2016-01