Potential Abnormality of Glucose ToleranceNCT04857554
Effects of Sugar-free Products With Added Sweeteners on Glycemic Responses
A study testing Glucose as reference food, White bread as reference food and White bread with apricot jam in people with Potential Abnormality of Glucose Tolerance and Appetitive Behavior, run by Agricultural University of Athens at 1 site in Greece.
Trial summary
This study investigated the effects of three commonly used sugar-free snacks with added sweeteners on glycemic responses Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Potential Abnormality of Glucose Tolerance, Appetitive Behavior
- What is being tested?
- Glucose as reference food, White bread as reference food and White bread with apricot jam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteGreece
- Study dates
- 30 Jul 2020to 30 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy
- non-smoking
- non-diabetic men and women
- body mass index (BMI) between 18 and 29.9 kg/m2
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
This study investigated the effects of three commonly used sugar-free snacks with added sweeteners on glycemic responses
Read the detailed description
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
- Being tested
- Glucose as reference food, White bread as reference food, White bread with apricot jam, Cereal bar with cranberries, Cocoa drink
- Keywords
- blood glucose, glycemic index, cereal bar, jam, cocoa
- Medical subject headings
- Appetitive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glucose as reference foodOther
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.
White bread as reference foodOther
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.
White bread with apricot jamOther
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.
Cereal bar with cranberriesOther
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.
Cocoa drinkOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Glucose as reference food | Experimental | 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. Receives: 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 |
| White bread as reference food | Experimental | 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. Receives: 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 |
| White bread with apricot jam | Experimental | 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. Receives: 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 |
| Cereal bar with cranberries | Experimental | 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. Receives: 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 |
| Cocoa drink | Experimental | 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 hours
Secondary outcomes (1)
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.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2021
- Study start30 Jul 2020
- Primary completion30 Sep 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Potential Abnormality of Glucose ToleranceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Crossover Assignment
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Agricultural University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aimilia Papakonstantinou, Agricultural University of Athens
- Investigators
- Aimilia Papakonstantinou, PhD, Principal investigator, Agricultural University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04857554
- Sponsor's protocol ID
- HRBD 23 08/07/2020
- Status last verified
- Apr 2021
- First submitted
- 21 Apr 2021
- Last updated
- 23 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04857554
- Acronym / sponsor ID
- HRBD 23 08/07/2020
- Keywords
- blood glucose, glycemic index, cereal bar, jam, cocoa
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Agricultural University of AthensUniversity, hospital or other
- Study start
- 30 Jul 2020 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 23 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study investigated the effects of three commonly used sugar-free snacks with added sweeteners on glycemic responses
Detailed description
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 5
- Model description
- Crossover Assignment
| Arm | Type | Receives |
|---|---|---|
| Glucose as reference food | Experimental | Other: Glucose as reference food, Other: White bread as reference food, Other: White bread with apricot jam, Other: Cereal bar with cranberries, Other: Cocoa drinkTwelve 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. |
| White bread as reference food | Experimental | Other: Glucose as reference food, Other: White bread as reference food, Other: White bread with apricot jam, Other: Cereal bar with cranberries, Other: Cocoa drinkTwelve 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. |
| White bread with apricot jam | Experimental | Other: Glucose as reference food, Other: White bread as reference food, Other: White bread with apricot jam, Other: Cereal bar with cranberries, Other: Cocoa drinkTwelve 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. |
| Cereal bar with cranberries | Experimental | Other: Glucose as reference food, Other: White bread as reference food, Other: White bread with apricot jam, Other: Cereal bar with cranberries, Other: Cocoa drinkTwelve 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. |
| Cocoa drink | Experimental | Other: Glucose as reference food, Other: White bread as reference food, Other: White bread with apricot jam, Other: Cereal bar with cranberries, Other: Cocoa drinkTwelve 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- healthy
- non-smoking
- non-diabetic men and women
- body mass index (BMI) between 18 and 29.9 kg/m2
Key exclusion criteria (7 listed)
- severe chronic disease (e.g. coronary heart disease, diabetes mellitus,kidney or liver conditions, endocrine conditions)
- gastrointestinal disorders
- pregnancy
- lactation
- competitive sports
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glucose as reference foodTwelve 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. | Other | Cereal bar with cranberries, Cocoa drink, Glucose as reference food, White bread as reference food, White bread with apricot jam |
| White bread as reference foodTwelve 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. | Other | Cereal bar with cranberries, Cocoa drink, Glucose as reference food, White bread as reference food, White bread with apricot jam |
| White bread with apricot jamTwelve 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. | Other | Cereal bar with cranberries, Cocoa drink, Glucose as reference food, White bread as reference food, White bread with apricot jam |
| Cereal bar with cranberriesTwelve 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. | Other | Cereal bar with cranberries, Cocoa drink, Glucose as reference food, White bread as reference food, White bread with apricot jam |
| Cocoa drinkTwelve 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. | Other | Cereal bar with cranberries, Cocoa drink, Glucose as reference food, White bread as reference food, White bread with apricot jam |
Primary outcome
Capillary blood glucose responses
Time frame: 2 hours
Clinically useful change in blood glucose, defined as the restoration of glucose within normal limits during the 2hr glucose tolerance test
1 secondary outcome
Subjective appetite ratings
Time frame: 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2021.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aimilia Papakonstantinou, PhD principal investigator
Agricultural University of Athens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glucose as reference food, White bread as reference food and White bread with apricot jam in people with Potential Abnormality of Glucose Tolerance and Appetitive Behavior, run by Agricultural University of Athens at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Capillary blood glucose responses (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2021.