Effects of Sugar-free Products With Added Sweeteners on Glycemic Responses

Study Overview
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Brief Summary
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This study investigated the effects of three commonly used sugar-free snacks with added sweeteners on glycemic responses

Detailed Description
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This study aimed at 1. to determine the glycemic index and glycemic load of three sugar-free products with added sweeteners: apricot jam, cranberry cereal bar, and cocoa drink, and 2. to investigate the effects of these products on the postprandial glycemic response in healthy subjects

Official Title
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Effects of Sugar-free Products With Added Sweeteners: Apricot Jam, Cranberry Cereal Bar, and Cocoa Drink on Glycemic Responses: Randomized Clinical Trial in Healthy Humans

Conditions
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Potential Abnormality of Glucose Tolerance, Appetitive Behavior

Intervention / Treatment
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* Other: Glucose as reference food
* Other: White bread as reference food
* Other: White bread with apricot jam
* Other: Cereal bar with cranberries
* Other: Cocoa drink


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: healthy non-smoking non-diabetic men and women body mass index (BMI) between 18 and 29.9 kg/m2 Exclusion Criteria: severe chronic disease (e.g. coronary heart disease, diabetes mellitus,kidney or liver conditions, endocrine conditions) gastrointestinal disorders pregnancy lactation competitive sports alcohol drug dependency

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Glucose as reference food<br>Twelve healthy, normal weight subjects (male: 6, female: 6) after 10-14 hr fast, consumed 25g available carbohydrate from D-glucose, three times, in different weeks as reference food along with 250ml water; and 25g available carbohydrates from white bread, white bread and apricot jam, cereal bar with cranberries, and cocoa drink, tested once, in different weeks along with 250ml water or 500ml fat-free milk for the cocoa drink. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min. The first glucose sample was taken exactly 15min after the first bite of food or drink. | Other: Glucose as reference food<br>* Twelve healthy, normal weight subjects (male: 6,female: 6) after 10-14 hr fast, consumed 25g glucose diluted in 250ml water, tested twice, in different weeks, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45,60, 90 and 120min.<br>Other: White bread as reference food<br>* Twelve healthy, normal weight subjects (male: 6,female: 6) after 10-14 hr fast, consumed 25g available carbohydrates from white bread along with 250ml water, tested once, in different weeks, within 10-15min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45,60, 90 and 120min.<br>Other: White bread with apricot jam<br>* Twelve healthy, normal weight subjects (male: 6,female: 6) after 10-14 hr fast, consumed 25g available carbohydrates from white bread together with apricot jam along with 250ml water, tested once, in different weeks, within 10-15min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45,60, 90 and 120min.<br>Other: Cereal bar with cranberries<br>* Twelve healthy, normal weight subjects (male: 6,female: 6) after 10-14 hr fast, consumed 25g available carbohydrates from a cereal bar with cranberries along with 250ml water, tested once, in different weeks, within 10-15min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45,60, 90 and 120min.<br>Other: Cocoa drink<br>* Twelve healthy, normal weight subjects (male: 6,female: 6) after 10-14 hr fast, consumed 25g available carbohydrates from cocoa powder mixed with 500ml fat-free milk, tested once, in different weeks, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45,60, 90 and 120min.<br>|
| Experimental: White bread as reference food<br>Twelve healthy, normal weight subjects (male: 6, female: 6) after 10-14 hr fast, consumed 25g available carbohydrate from D-glucose, three times, in different weeks as reference food along with 250ml water; and 25g available carbohydrates from white bread, white bread and apricot jam, cereal bar with cranberries, and cocoa drink, tested once, in different weeks along with 250ml water or 500ml fat-free milk for the cocoa drink. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min. The first glucose sample was taken exactly 15min after the first bite of food or drink. | Other: Glucose as reference food<br>* Twelve healthy, normal weight subjects (male: 6,female: 6) after 10-14 hr fast, consumed 25g glucose diluted in 250ml water, tested twice, in different weeks, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45,60, 90 and 120min.<br>Other: White bread as reference food<br>* Twelve healthy, normal weight subjects (male: 6,female: 6) after 10-14 hr fast, consumed 25g available carbohydrates from white bread along with 250ml water, tested once, in different weeks, within 10-15min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45,60, 90 and 120min.<br>Other: White bread with apricot jam<br>* Twelve healthy, normal weight subjects (male: 6,female: 6) after 10-14 hr fast, consumed 25g available carbohydrates from white bread together with apricot jam along with 250ml water, tested once, in different weeks, within 10-15min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45,60, 90 and 120min.<br>Other: Cereal bar with cranberries<br>* Twelve healthy, normal weight subjects (male: 6,female: 6) after 10-14 hr fast, consumed 25g available carbohydrates from a cereal bar with cranberries along with 250ml water, tested once, in different weeks, within 10-15min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45,60, 90 and 120min.<br>Other: Cocoa drink<br>* Twelve healthy, normal weight subjects (male: 6,female: 6) after 10-14 hr fast, consumed 25g available carbohydrates from cocoa powder mixed with 500ml fat-free milk, tested once, in different weeks, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45,60, 90 and 120min.<br>|
| Experimental: White bread with apricot jam<br>Twelve healthy, normal weight subjects (male: 6, female: 6) after 10-14 hr fast, consumed 25g available carbohydrate from D-glucose, three times, in different weeks as reference food along with 250ml water; and 25g available carbohydrates from white bread, white bread and apricot jam, cereal bar with cranberries, and cocoa drink, tested once, in different weeks along with 250ml water or 500ml fat-free milk for the cocoa drink. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min. The first glucose sample was taken exactly 15min after the first bite of food or drink. | Other: Glucose as reference food<br>* Twelve healthy, normal weight subjects (male: 6,female: 6) after 10-14 hr fast, consumed 25g glucose diluted in 250ml water, tested twice, in different weeks, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45,60, 90 and 120min.<br>Other: White bread as reference food<br>* Twelve healthy, normal weight subjects (male: 6,female: 6) after 10-14 hr fast, consumed 25g available carbohydrates from white bread along with 250ml water, tested once, in different weeks, within 10-15min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45,60, 90 and 120min.<br>Other: White bread with apricot jam<br>* Twelve healthy, normal weight subjects (male: 6,female: 6) after 10-14 hr fast, consumed 25g available carbohydrates from white bread together with apricot jam along with 250ml water, tested once, in different weeks, within 10-15min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45,60, 90 and 120min.<br>Other: Cereal bar with cranberries<br>* Twelve healthy, normal weight subjects (male: 6,female: 6) after 10-14 hr fast, consumed 25g available carbohydrates from a cereal bar with cranberries along with 250ml water, tested once, in different weeks, within 10-15min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45,60, 90 and 120min.<br>Other: Cocoa drink<br>* Twelve healthy, normal weight subjects (male: 6,female: 6) after 10-14 hr fast, consumed 25g available carbohydrates from cocoa powder mixed with 500ml fat-free milk, tested once, in different weeks, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45,60, 90 and 120min.<br>|
| Experimental: Cereal bar with cranberries<br>Twelve healthy, normal weight subjects (male: 6, female: 6) after 10-14 hr fast, consumed 25g available carbohydrate from D-glucose, three times, in different weeks as reference food along with 250ml water; and 25g available carbohydrates from white bread, white bread and apricot jam, cereal bar with cranberries, and cocoa drink, tested once, in different weeks along with 250ml water or 500ml fat-free milk for the cocoa drink. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min. The first glucose sample was taken exactly 15min after the first bite of food or drink. | Other: Glucose as reference food<br>* Twelve healthy, normal weight subjects (male: 6,female: 6) after 10-14 hr fast, consumed 25g glucose diluted in 250ml water, tested twice, in different weeks, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45,60, 90 and 120min.<br>Other: White bread as reference food<br>* Twelve healthy, normal weight subjects (male: 6,female: 6) after 10-14 hr fast, consumed 25g available carbohydrates from white bread along with 250ml water, tested once, in different weeks, within 10-15min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45,60, 90 and 120min.<br>Other: White bread with apricot jam<br>* Twelve healthy, normal weight subjects (male: 6,female: 6) after 10-14 hr fast, consumed 25g available carbohydrates from white bread together with apricot jam along with 250ml water, tested once, in different weeks, within 10-15min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45,60, 90 and 120min.<br>Other: Cereal bar with cranberries<br>* Twelve healthy, normal weight subjects (male: 6,female: 6) after 10-14 hr fast, consumed 25g available carbohydrates from a cereal bar with cranberries along with 250ml water, tested once, in different weeks, within 10-15min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45,60, 90 and 120min.<br>Other: Cocoa drink<br>* Twelve healthy, normal weight subjects (male: 6,female: 6) after 10-14 hr fast, consumed 25g available carbohydrates from cocoa powder mixed with 500ml fat-free milk, tested once, in different weeks, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45,60, 90 and 120min.<br>|
| Experimental: Cocoa drink<br>Twelve healthy, normal weight subjects (male: 6, female: 6) after 10-14 hr fast, consumed 25g available carbohydrate from D-glucose, three times, in different weeks as reference food along with 250ml water; and 25g available carbohydrates from white bread, white bread and apricot jam, cereal bar with cranberries, and cocoa drink, tested once, in different weeks along with 250ml water or 500ml fat-free milk for the cocoa drink. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min. The first glucose sample was taken exactly 15min after the first bite of food or drink. | Other: Glucose as reference food<br>* Twelve healthy, normal weight subjects (male: 6,female: 6) after 10-14 hr fast, consumed 25g glucose diluted in 250ml water, tested twice, in different weeks, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45,60, 90 and 120min.<br>Other: White bread as reference food<br>* Twelve healthy, normal weight subjects (male: 6,female: 6) after 10-14 hr fast, consumed 25g available carbohydrates from white bread along with 250ml water, tested once, in different weeks, within 10-15min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45,60, 90 and 120min.<br>Other: White bread with apricot jam<br>* Twelve healthy, normal weight subjects (male: 6,female: 6) after 10-14 hr fast, consumed 25g available carbohydrates from white bread together with apricot jam along with 250ml water, tested once, in different weeks, within 10-15min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45,60, 90 and 120min.<br>Other: Cereal bar with cranberries<br>* Twelve healthy, normal weight subjects (male: 6,female: 6) after 10-14 hr fast, consumed 25g available carbohydrates from a cereal bar with cranberries along with 250ml water, tested once, in different weeks, within 10-15min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45,60, 90 and 120min.<br>Other: Cocoa drink<br>* Twelve healthy, normal weight subjects (male: 6,female: 6) after 10-14 hr fast, consumed 25g available carbohydrates from cocoa powder mixed with 500ml fat-free milk, tested once, in different weeks, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45,60, 90 and 120min.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Capillary blood glucose responses | Clinically useful change in blood glucose, defined as the restoration of glucose within normal limits during the 2hr glucose tolerance test | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective appetite ratings | Useful change in subjective appetite using visual analogue scales with a score 0 to 10 (given in the form of booklet,one scale per page) at baseline, 15, 30, 45, 60, 90 and 120 min. The minimum or maximum score will be evaluated if it is better or worse depending on the appetite variable e.g hunger, satiety, desire to eat etc. | 2 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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blood glucose, glycemic index, cereal bar, jam, cocoa