Effect of Macronutrient Supplementation on Glycemic Index of Pita Bread

NCT02598986 | Completed

• 1 other identifier: NUT.OO.19
• Study Type: interventional
• Target: 96
• Locations: 0 countries
• Sites: N/A

Brief Summary

Glycemic index (GI) of food is known to be positively associated with the development of several diseases including type 2 diabetes, cardiovascular disease and age-related macular degeneration. Modest dietary changes from high-GI foods to low-GI foods have shown beneficial effects. These findings have been translated to recommendations for increased dietary intake of whole grains. However, the inverse relationship between whole grain consumption and risk of the different components of metabolic syndrome has not been explained by their fiber content. Trials of added cereal fiber have failed to induce a protective effect and fiber has thus been proposed to be a marker of other components of whole grains that impart health advantages. Whole wheat grains are known to be a rich source of several minerals (phosphorus, potassium and magnesium) that play a role in glucose metabolism, and are depleted during the process of refinement. Thus, it is plausible to hypothesize that the benefits of whole grains previously ascribed to their fiber content are in fact due to these minerals. The proposed research aims to restore or fortify white bread with these minerals and determine the resulting glycemic index of mineral-fortified bread. With much evidence that most people prefer the taste and color of white bread, a low GI, mineral fortified white bread has the potential to reduce the risk of Metabolic Syndrome in those who consume it.

Conditions

Diabetes

Keywords

glycemic index, pita bread, phosphorus, potassium, magnesium

Outcome Measures

Primary Outcomes (1)

• AUC of serum glucose

  two hours

Study Arms (4)

white pita bread

PLACEBO COMPARATOR

Pita bread made of white wheat flour

Dietary Supplement: Macronutrient supplementation

Whole grain pita bread

NO INTERVENTION

no macronutrient supplementation

Restored white pita bread

EXPERIMENTAL

macronutrient supplementation

Dietary Supplement: Macronutrient supplementation

Fortified white pita bread

EXPERIMENTAL

macronutrient supplementation 2

Dietary Supplement: Macronutrient supplementation

Interventions

Macronutrient supplementation DIETARY_SUPPLEMENT

adding of phosphorus, potassium and magnesium

Fortified white pita bread; Restored white pita bread; white pita bread

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \- Healthy subjects

You may not qualify if:

• any disease, pregnant and lactating

Sponsors & Collaborators

• American University of Beirut Medical Center: lead

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 4, 2015
• First Posted: November 6, 2015
• Study Start: June 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: November 6, 2015

Record last verified: 2015-11