A Trial on the GI of Spaghetti Versus Rice as Mixed Meals

May 2, 2018 updated by: Francesca Scazzina Ph.D., University of Parma

The Importance of Glycemic Index on Postprandial Glycemia and Insulinemia in the Context of the Addition of Fat to Carbohydrate Foods: A Randomized Controlled Trial on Spaghetti Versus Rice as Mixed Meals

Pasta and rice are two of the most commonly consumed grains worldwide, where the former has a low GI (e.g. spaghetti) and the latter, usually (as it depends on the type) has a higher GI (e.g. white rice). The most typical ways in which pasta and rice are consumed are with the addition of oil or tomato sauce, and are recommended to be consumed in this way in the Mediterranean diet. The Mediterranean diet has been demonstrated to reduce the risk of cardiovascular disease, improve glycemic control and is encouraged in many clinical guidelines globally for both cardiovascular risk reduction. Some studies have explored the differences in glycemic response of different carbohydrate foods consumed with the addition of fat demonstrating that the glycemic response is indeed reduced.However, the GI may remain of importance even when other means to reduce glycemic response are introduced.

The investigators therefore designed a randomized controlled crossover study to explore whether the addition of fat in the form of commonly consumed sauces which are recommended as part of a Mediterranean diet, affects the difference in glycemic response between a commonly consumed low GI and a higher GI carbohydrate food.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background:

Pasta and rice are two of the most commonly consumed grains worldwide, where the former has a low GI (e.g. spaghetti) and the latter, usually (as it depends on the type) has a higher GI (e.g. white rice). Low GI foods have been demonstrated to improve glycemic control, insulin sensitivity and diabetes management, and have been associated with reduced risk of chronic disease, including coronary heart disease. Therefore, GI is of importance as a potential dietary strategy to reduce postprandial glycemia and improve glycemic control, particularly with the increasing rates of diabetes.

Several studies have demonstrated how the addition of fat to a meal can reduce the glycemic response, some of which have suggested in a dose response manner. The mechanism by which increasing fat reduces the glycemic response may be through the effects on gastric emptying. Fat may modulate the gut hormones cholecystokinin (CCK) and peptide YY, which delay gastric emptying, which is known to be a major determinant of postprandial glycemia where small changes can have a substantial effect. Low GI foods result in lower glycemic excursions compared to higher GI foods, which, in addition to gastric emptying, may exert this effect through various pathways. Thus, there is importance of exploring the potential additional benefit beyond reducing the glycemic response with the addition of fat.

The most typical ways in which pasta and rice are consumed are with the addition of oil or tomato sauce, and are recommended to be consumed in this way in the Mediterranean diet. Among many benefits, the Mediterranean diet has been demonstrated to reduce the risk of cardiovascular disease, improved glycemic control and is encouraged in many clinical guidelines globally for both cardiovascular risk reduction and for diabetes. Some studies have explored the differences in glycemic response of different carbohydrate foods consumed with the addition of fat demonstrating that the glycemic response is indeed reduced.However, the GI may remain of importance even when other means to reduce glycemic response are introduced.

The investigators therefore designed a randomized controlled crossover study to explore whether the addition of fat in the form of commonly consumed sauces which are recommended as part of a Mediterranean diet, affects the difference in glycemic response between a commonly consumed low GI and a higher GI carbohydrate food.

Objective:

To assess whether the addition of fat to a low GI and higher GI carbohydrate food lowers the glycemic response equivalently, thus whether the difference between the low and higher GI food is preserved.

Scope:

The principal scope of the study is to evaluate the impact of two carbohydrate-containing foods varying in glycemic index, spaghetti and rice, on postprandial glucose.

To confirm that the two foods vary in GI, the GI of the rice will first be tested in Part A, since the GI of spaghetti has already been determined in the investigator's lab.

In Part B of the study, following the consumption of the test foods by healthy volunteers (see Study Design), the investigators will evaluate the differences in postprandial glucose, as well as insulin and c-peptide.

Implications:

These results will determine whether there is an independent effect of the GI of a carbohydrate containing food when fat is added to a meal in the context of how is it commonly and recommended to be consumed. These results may be useful to encourage the use of low GI foods for greater improvements in glycemic and insulinemic control, which is an important public health concern in today's global society.

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Parma, Italy, 43125
        • Department of Food and Drug, University of Parma

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • generally healthy

Exclusion Criteria:

  • BMI≥30kg/m2
  • have any health conditions (including anemia and metabolic conditions such as hypertension, dyslipidemia, impaired glucose intolerance or diabetes)
  • have celiac disease
  • perform intense physical activity (LAF ≥2.10 - LARN 2014)
  • currently taking any prescription medication for chronic diseases (including psychiatric)
  • dietary supplements affecting the metabolism
  • Women who are pregnant or breastfeeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Glucose #1
50 grams of available carbohydrate from glucose monohydrate will be dissolved in 250mL water and consumed as a test meal
50g available carbohydrate
Other Names:
  • Glucose Monohydrate
ACTIVE_COMPARATOR: Spaghetti
50 grams of available carbohydrate from spaghetti will be cooked according to package instructions and consumed as a test meal
50g available carbohydrate
ACTIVE_COMPARATOR: Rice
50 grams of available carbohydrate from white rice will be cooked according to package instructions and consumed as a test meal
50g available carbohydrate
Other Names:
  • white rice
ACTIVE_COMPARATOR: Spaghetti + tomato sauce
50 grams of available carbohydrate from spaghetti plus tomato sauce (1:1 ratio) will be cooked according to package instructions and consumed as a test meal
50g available carbohydrate
ACTIVE_COMPARATOR: Rice + tomato sauce
50 grams of available carbohydrate from white rice plus tomato sauce (1:1 ratio) will be cooked according to package instructions and consumed as a test meal
50g available carbohydrate
Other Names:
  • white rice + tomato sauce
ACTIVE_COMPARATOR: Spaghetti + Pesto
50 grams of available carbohydrate from spaghetti plus pesto sauce (1:0.5 ratio) will be cooked according to package instructions and consumed as a test meal
50g available carbohydrate
ACTIVE_COMPARATOR: Rice + Pesto
50 grams of available carbohydrate from white rice plus pesto sauce (1:0.5 ratio) will be cooked according to package instructions and consumed as a test meal
50g available carbohydrate
Other Names:
  • white rice + pesto
OTHER: Glucose #2
50 grams of available carbohydrate from glucose monohydrate will be dissolved in 250mL water and consumed as a test meal
50g available carbohydrate
Other Names:
  • Glucose Monohydrate
OTHER: Glucose #3
50 grams of available carbohydrate from glucose monohydrate will be dissolved in 250mL water and consumed as a test meal
50g available carbohydrate
Other Names:
  • Glucose Monohydrate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glycemic Index
Time Frame: 2 hours (-10 and 0 -fasting-, 15, 30, 45, 60, 90, 120 minutes)
postprandial response for glucose (IAUC); Comparisons will be made between the spaghetti and rice IAUCs in each of the 3 contexts (alone, with tomato sauce, with pesto)
2 hours (-10 and 0 -fasting-, 15, 30, 45, 60, 90, 120 minutes)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postprandial Insulin
Time Frame: 2 hours (-10 and 0 -fasting-, 15, 30, 45, 60, 90, 120 minutes)
postprandial response for plasma insulin (IAUC)
2 hours (-10 and 0 -fasting-, 15, 30, 45, 60, 90, 120 minutes)
Postprandial C-peptide
Time Frame: 2 hours (-10 and 0 -fasting-, 15, 30, 45, 60, 90, 120 minutes)
postprandial response for plasma c-peptide (IAUC)
2 hours (-10 and 0 -fasting-, 15, 30, 45, 60, 90, 120 minutes)
Peak Glucose
Time Frame: 2 hours (-10 and 0 -fasting-, 15, 30, 45, 60, 90, 120 minutes)
maximum value of postprandial glucose response
2 hours (-10 and 0 -fasting-, 15, 30, 45, 60, 90, 120 minutes)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Satiety using a 100cm visual analog scale
Time Frame: 2 hours
differences in subject-rated satiety using a 100cm visual analog scale
2 hours
Palatability using a 100cm visual analog scale
Time Frame: 12 minutes
differences in subject-rated palatability using a 100cm visual analog scale
12 minutes
Gastrointestinal Symptoms using a questionnaire
Time Frame: 2 hours
differences in subject-rated gastrointestinal symptom questionnaire
2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Francesca Scazzina, PhD, Department of Food and Drug, University of Parma
  • Study Director: Furio Brighenti, PhD, Department of Food and Drug, University of Parma

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 27, 2017

Primary Completion (ACTUAL)

March 12, 2018

Study Completion (ACTUAL)

April 30, 2018

Study Registration Dates

First Submitted

March 27, 2017

First Submitted That Met QC Criteria

April 6, 2017

First Posted (ACTUAL)

April 7, 2017

Study Record Updates

Last Update Posted (ACTUAL)

May 3, 2018

Last Update Submitted That Met QC Criteria

May 2, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Pasta+Sauces

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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