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Trial record 96 of 1079 for:    Area Under Curve AND insulin

Glycemic and Insulinemic Responses of Low-Carbohydrate Snack Foods

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04175496
Recruitment Status : Not yet recruiting
First Posted : November 25, 2019
Last Update Posted : November 25, 2019
Sponsor:
Information provided by (Responsible Party):
Zeynep Caferoglu, PhD, TC Erciyes University

Brief Summary:
The aim of this study is develop recipes containing CHO less than ICR, prepare new snacks alternatives that could be consumed without need for additional insulin doses, and evaluate the glycemic and insulinemic responses of these recipes. A randomized crossover trial will include 15 healthy adults aged 19-30 years. All participants will consume 3 test foods and reference food (glucose solution, 2 times) in a random order. Blood samples will be collected at time points 0,15, 30, 45, 60, 90 and 120 min. Glucose and insulin analyzes will be performed from blood samples. The results of these time points will be marked on the chart and the incremental area under the curve (iAUC) will be calculated for both glucose and insulin.

Condition or disease Intervention/treatment Phase
Healthy Other: Blueberry Cake Other: Snacks with Cheese Other: Spicy Crackers Other: Glucose Solution First Repeat Other: Glucose Solution Second Repeat Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Glycemic and Insulinemic Responses of Low-Carbohydrate Snack Foods
Estimated Study Start Date : December 1, 2019
Estimated Primary Completion Date : March 1, 2020
Estimated Study Completion Date : April 1, 2020

Arm Intervention/treatment
Experimental: Test Foods
Blueberry Cake, Snack with Cheese and spicy Crackers will be used as test foods.
Other: Blueberry Cake
Blueberry cake containing 25 g available CHO will be served to the participants after 10-hours fasting and asked to consume it within 15 minutes, along with 250 ml of water. Taking the first bite from test food will be considered as 0 min. Blood samples will be collected at time points 0,15, 30, 45, 60, 90 and 120 min.

Other: Snacks with Cheese
Snacks with cheese containing 25 g available CHO will be served to the participants after 10-hours fasting and asked to consume it within 15 minutes, along with 250 ml of water. Taking the first bite from test food will be considered as 0 min. Blood samples will be collected at time points 0,15, 30, 45, 60, 90 and 120 min.

Other: Spicy Crackers
Spicy crackers containing 25 g available CHO will be served to the participants after 10-hours fasting and asked to consume it within 15 minutes, along with 250 ml of water. Taking the first bite from test food will be considered as 0 min. Blood samples will be collected at time points 0,15, 30, 45, 60, 90 and 120 min.

Experimental: Reference Food
Glucose solution will use as reference food.
Other: Glucose Solution First Repeat
The glucose solution will be prepared by dissolving 25 g of glucose in 250 ml of water. Participants consume the glucose solution within 15 minutes after 10-hours fasting. Blood samples will be collect at time points 0,15, 30, 45, 60, 90 and 120 min.

Other: Glucose Solution Second Repeat
The glucose solution will be prepared by dissolving 25 g of glucose in 250 ml of water. Participants consume the glucose solution within 15 minutes after 10-hours fasting. Blood samples will be collect at time points 0,15, 30, 45, 60, 90 and 120 min.




Primary Outcome Measures :
  1. Postprandial glucose response [ Time Frame: two hours postprandial period ]
    Postprandial glucose response will be quantified as incremental area under the curve (iAUC) (mg/dL x minutes), which is calculated according to the trapezoidal rule by using blood glucose values at time points 0, 15, 30, 45, 60, 90, and 120 minutes.

  2. Postprandial insulin response [ Time Frame: two hours postprandial period ]
    Postprandial insulin response will be quantified as incremental area under the curve (iAUC) (mg/dL x minutes), which is calculated according to the trapezoidal rule by using blood glucose values at time points 0, 15, 30, 45, 60, 90, and 120 minutes.



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Ages Eligible for Study:   19 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy volunteer
  • Normal body weight (18.5-25 kg / m2 BMI)
  • 19-30 years old

Exclusion Criteria:

  • use of tobacco,
  • weight change of >5 kg in the last 3 months
  • the presence of any chronic disease or lactose intolerance,
  • regular medicine use,
  • pregnancy or lactation,
  • performing competitive sports or endurance sports,
  • fasting plasma glucose concentration >100 mg / dL,
  • the presence of eating disorder,
  • sensitivity or allergies to any food that used in the study

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): NCT04175496


Contacts
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Contact: Zeynep Caferoğlu, PhD +903524379282 ext 28562 zeynepcaferoglu@gmail.com

Locations
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Turkey
Erciyes University Faculty of Health Sciences
Kayseri, Turkey, 38100
Sponsors and Collaborators
TC Erciyes University
  Study Documents (Full-Text)

Documents provided by Zeynep Caferoglu, PhD, TC Erciyes University:

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Responsible Party: Zeynep Caferoglu, PhD, Assistant Professor Doctor, TC Erciyes University
ClinicalTrials.gov Identifier: NCT04175496    
Other Study ID Numbers: ND
First Posted: November 25, 2019    Key Record Dates
Last Update Posted: November 25, 2019
Last Verified: November 2019

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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 Zeynep Caferoglu, PhD, TC Erciyes University:
Glycemic index
Insulinemic index
Low carbohydrate
Snack
Type 1 diabetes
Additional relevant MeSH terms:
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Pharmaceutical Solutions