NCT04175496

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Dec 2019

Shorter than P25 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 21, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 25, 2019

Completed
6 days until next milestone

Study Start

First participant enrolled

December 1, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed
Last Updated

February 9, 2021

Status Verified

February 1, 2021

Enrollment Period

3 months

First QC Date

November 21, 2019

Last Update Submit

February 6, 2021

Conditions

Healthy

Keywords

Glycemic indexInsulinemic indexLow carbohydrateSnackType 1 diabetes

Outcome Measures

Primary Outcomes (2)

  • Postprandial glucose response

    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.

    two hours postprandial period

  • Postprandial insulin response

    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.

    two hours postprandial period

Study Arms (2)

Test Foods

EXPERIMENTAL

Blueberry Cake, Snack with Cheese and spicy Crackers will be used as test foods.

Other: Blueberry CakeOther: Snacks with CheeseOther: Spicy Crackers

Reference Food

EXPERIMENTAL

Glucose solution will use as reference food.

Other: Glucose Solution First RepeatOther: Glucose Solution Second Repeat

Interventions

Blueberry CakeOTHER

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.

Test Foods
Snacks with CheeseOTHER

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.

Test Foods
Spicy CrackersOTHER

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.

Test Foods
Glucose Solution First RepeatOTHER

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.

Reference Food
Glucose Solution Second RepeatOTHER

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.

Reference Food

Eligibility Criteria

Age19 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erciyes University Faculty of Health Sciences

Kayseri, 38100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

SnacksCheese

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

MealsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesCultured Milk ProductsMilkBeveragesFermented FoodsDairy Products

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor Doctor

Study Record Dates

First Submitted

November 21, 2019

First Posted

November 25, 2019

Study Start

December 1, 2019

Primary Completion

March 1, 2020

Study Completion

April 1, 2020

Last Updated

February 9, 2021

Record last verified: 2021-02

Locations

TU(1)