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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03104712
Recruitment Status : Completed
First Posted : April 7, 2017
Last Update Posted : May 3, 2018
Sponsor:
Information provided by (Responsible Party):
Francesca Scazzina Ph.D., University of Parma

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Dietary Modification Other: Glucose #1 Other: Glucose #2 Other: Glucose #3 Other: Spaghetti Other: Rice Other: Spaghetti + Tomato Sauce Other: Rice + Tomato Sauce Other: Spaghetti + Pesto Other: Rice + Pesto Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Masking Description: The outcomes assessor will be unaware of the intervention associated with the samples being analyzed.
Primary Purpose: Basic Science
Official Title: 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
Actual Study Start Date : April 27, 2017
Actual Primary Completion Date : March 12, 2018
Actual Study Completion Date : April 30, 2018

Arm Intervention/treatment
Glucose #1
50 grams of available carbohydrate from glucose monohydrate will be dissolved in 250mL water and consumed as a test meal
Other: Glucose #1
50g available carbohydrate
Other Name: 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
Other: Spaghetti
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
Other: Rice
50g available carbohydrate
Other Name: 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
Other: Spaghetti + Tomato Sauce
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
Other: Rice + Tomato Sauce
50g available carbohydrate
Other Name: 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
Other: Spaghetti + Pesto
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
Other: Rice + Pesto
50g available carbohydrate
Other Name: white rice + pesto

Glucose #2
50 grams of available carbohydrate from glucose monohydrate will be dissolved in 250mL water and consumed as a test meal
Other: Glucose #2
50g available carbohydrate
Other Name: Glucose Monohydrate

Glucose #3
50 grams of available carbohydrate from glucose monohydrate will be dissolved in 250mL water and consumed as a test meal
Other: Glucose #3
50g available carbohydrate
Other Name: Glucose Monohydrate




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Postprandial Insulin [ Time Frame: 2 hours (-10 and 0 -fasting-, 15, 30, 45, 60, 90, 120 minutes) ]
    postprandial response for plasma insulin (IAUC)

  2. 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)

  3. Peak Glucose [ Time Frame: 2 hours (-10 and 0 -fasting-, 15, 30, 45, 60, 90, 120 minutes) ]
    maximum value of postprandial glucose response


Other Outcome Measures:
  1. Satiety using a 100cm visual analog scale [ Time Frame: 2 hours ]
    differences in subject-rated satiety using a 100cm visual analog scale

  2. Palatability using a 100cm visual analog scale [ Time Frame: 12 minutes ]
    differences in subject-rated palatability using a 100cm visual analog scale

  3. Gastrointestinal Symptoms using a questionnaire [ Time Frame: 2 hours ]
    differences in subject-rated gastrointestinal symptom questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03104712


Locations
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Italy
Department of Food and Drug, University of Parma
Parma, Italy, 43125
Sponsors and Collaborators
University of Parma
Investigators
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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:
Vinoy S, Lesdéma A, Cesbron-Lavau G, Goux A, and Meynier A. Chapter 13 Creating Food Products with a Lower Glycemic Index. The Glycemic Index: Applications in Practice. Taylor & Francis Group, 6000 Broken Sound Parkway NW, Suite 300, Boca Raton, FL 33487-2742 CRC Press. Pages 285-318.

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Responsible Party: Francesca Scazzina Ph.D., Assistant Professor, University of Parma
ClinicalTrials.gov Identifier: NCT03104712    
Other Study ID Numbers: Pasta+Sauces
First Posted: April 7, 2017    Key Record Dates
Last Update Posted: May 3, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Francesca Scazzina Ph.D., University of Parma:
glycemic index