PrediabetesHB-RCT2-2015NCT04747639
Glycemic Response to Two Doses of Low Sugar Apple Juice
A study testing 500 ml glucose-depleted apple juice, 500 ml conventional apple juice and 250 ml glucose-depleted apple juice in people with Prediabetes, run by Clinical Research Center Kiel GmbH at 1 site in Germany.
Trial summary
Single center, double-blind, randomized controlled cross-over trial with four treatments and four time points. The study has three primary objectives. The first primary objective is to confirm the reduction of postprandial glycemic and insulinemic response after consumption of 500 ml glucose-free apple juice compared… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prediabetes
- What is being tested?
- 500 ml glucose-depleted apple juice, 500 ml conventional apple juice and 250 ml glucose-depleted apple juice
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteGermany
- Study dates
- 28 Oct 2015to Feb 2021
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males aged ≥ 18y
- Impaired fasting glucose (IFG)
- Written informed consent
- Consent to collect stools and urine four times for three days
Who cannot join
- Subjects currently enrolled in another clinical study
- Subjects having finished another clinical study within the last 4 weeks before inclusion.
- Subjects having participated in the study HB-RCT1-2015
- Hypersensitivity, allergy or idiosyncratic reaction to apple, apple juice or other apple containing food
- Acute or chronic infections
- Renal insufficiency
Show all 22Show fewer
- Gastrointestinal illness
- No stools of type 5-7 of Bristol Stool Form Scale within the last week before inclusion
- History of gastrointestinal surgery
- Known fructose intolerance
- Overt diabetes mellitus
- Endocrine disorders
- Any disease or condition which might compromise significantly the hematopoietic, renal, endocrine, pulmonary, hepatic, cardiovascular, immunological, central nervous, dermatological or any other body system with the exception of the conditions defined by the inclusion criteria
- History of hepatitis B and C
- History of HIV infection
- History of coagulation disorders or pharmaceutical anti-coagulation (with the exception of acetylsalicylic acid)
- Regular medical treatment including OTC, which may have impact on the study aims (e.g. gluconic acid-containing OTCs, antidiabetic drugs, laxatives etc.)
- Major cognitive or psychiatric disorders
- Subjects who are scheduled to undergo hospitalization during the study period
- Eating disorders (e.g. anorexia, bulimia) or special diets (e.g. vegan, vegetarian)
- Present drug abuse or alcoholism
- Legal incapacity
Trial locations and contacts
1 site in 1 country.
Germany1 site
CRC Clinical Research Center Kiel
Kiel, Schleswig-Holstein, 24118
About this study
Official title: Double-blind, Randomized, Controlled, Four Treatment Four Period Cross-over Trial on Glycemic Response, Excretion of Gluconate and Tolerability of Two Doses of Low Sugar Apple Juice
Single center, double-blind, randomized controlled cross-over trial with four treatments and four time points.
The study has three primary objectives. The first primary objective is to confirm the reduction of postprandial glycemic and insulinemic response after consumption of 500 ml glucose-free apple juice compared to 500 ml untreated apple juice as could be shown in a previous study
Read the detailed description
Single center, double-blind, randomized controlled cross-over trial with four treatments and four time points.
The study has three primary objectives. The first primary objective is to confirm the in a previous study shown reduction of postprandial glycemic and insulinemic response after consumption of 500 ml glucose-free apple juice compared to 500 ml untreated apple juice.
The second primary objective is to show the reduction of postprandial glycemic response after consumption of 250 ml glucose-free apple juice compared to 250 ml untreated apple juice.
The third primary objective is to show the reduction of insulinemic response after consumption of 250 ml glucose-free apple juice compared to 250 ml untreated apple juice.
Secondary objectives include safety aspects, specifically the occurrence of diarrhoea in all four treatment groups, differences between treatment groups on the Bristol Stool Forms Scale, gastro-intestinal symptoms and laboratory parameters. In addition, gluconate excretion and excreted portion of ingested gluconate are of interest as well as faecal pH.
- Conditions
- Prediabetes
- Being tested
- 500 ml glucose-depleted apple juice, 500 ml conventional apple juice, 250 ml glucose-depleted apple juice, 250 ml conventional apple juice
- Keywords
- glycemic response, enzymatic conversion, gluconate
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
500 ml glucose-depleted apple juiceOther
500 ml conventional apple juiceOther
250 ml glucose-depleted apple juiceOther
250 ml conventional apple juiceOther
| Study group | Role | What they receive |
|---|---|---|
| verum 500 | Active comparator | 500 ml low sugar apple juice manufactured from conventional apple juice via a series of enzymatic reactions that end up in a final content of free glucose less than 0,5 g/l. Receives: Other: 500 ml glucose-depleted apple juice |
| control 500 | Placebo comparator | 500 ml conventional apple juice produced by a general apple juice production process (free glucose 17g/l) Receives: Other: 500 ml conventional apple juice |
| verum 250 | Active comparator | 250 ml low sugar apple juice manufactured from conventional apple juice via a series of enzymatic reactions that end up in a final content of free glucose less than 0,5 g/l. Receives: Other: 250 ml glucose-depleted apple juice |
| control 250 | Placebo comparator | 250 ml conventional apple juice produced by a general apple juice production process (free glucose 17g/l) Receives: Other: 250 ml conventional apple juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
iAUC glucose 500
Incremental AUC (iAUC120) of blood glucose levels (according to FAO/WHO) after 500 ml juice
Measured: 120 min after ingestion
iAUC insulin 500
iAUC insulin 500
Measured: 120 min after ingestion
iAUC glucose 250
Incremental AUC (iAUC120) of blood glucose levels (according to FAO/WHO) after 250 ml juice
Measured: 120 min after ingestion
iAUC insulin 250
iAUC insulin 250
Measured: 120 min after ingestion
Secondary outcomes (2)
diarrhea
Occurrence of diarrhoea as assessed by stool frequency and Bristol Stool Forms Scale (Lewis, 1997) (3 or more loose or liquid stools per day, definition according to the WHO)
Measured: before and 60 and 120 minutes after ingestion with respect to the last 2 hours
gastro-intestinal symptoms
Assessed by completing questionnaires on gastrointestinal symptoms (GSRS; Svedlund 1988; Dimenäs 1995; Revicki 1998)
Measured: before and 60 and 120 minutes after ingestion with respect to the last 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2021
- Study start28 Oct 2015
- Primary completion9 May 2016
- Study completionFeb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrediabetesStudies 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
- a double-blind randomised controlled cross-over trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinical Research Center Kiel GmbH
- Sponsor type
- University, hospital or other
- Collaborators
- Nofima
- Responsible party
- Sponsor
- Investigators
- Christiane Laue, Dr. (MD), Principal investigator, CRC Clinical Research Center Kiel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04747639
- Sponsor's protocol ID
- HB-RCT2-2015
- Acronym
- HB-RCT2-2015
- Status last verified
- Feb 2021
- First submitted
- 5 Feb 2021
- Last updated
- 4 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Randomized, Controlled, Four Treatment Four Period Cross-over Trial on Glycemic Response, Excretion of Gluconate and Tolerability of Two Doses of Low Sugar Apple Juice
- ClinicalTrials.gov ID
- NCT04747639
- Acronym / sponsor ID
- HB-RCT2-2015 / HB-RCT2-2015
- Conditions
- Prediabetes
- Keywords
- glycemic response, enzymatic conversion, gluconate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Clinical Research Center Kiel GmbHUniversity, hospital or other
- Collaborators
- Nofima
- Study start
- 28 Oct 2015 (actual)
- Primary completion
- 9 May 2016 (actual)
- Study completion
- Feb 2021 (actual)
- First posted
- 10 Feb 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.
Single center, double-blind, randomized controlled cross-over trial with four treatments and four time points.
The study has three primary objectives. The first primary objective is to confirm the reduction of postprandial glycemic and insulinemic response after consumption of 500 ml glucose-free apple juice compared to 500 ml untreated apple juice as could be shown in a previous study
Detailed description
Single center, double-blind, randomized controlled cross-over trial with four treatments and four time points.
The study has three primary objectives. The first primary objective is to confirm the in a previous study shown reduction of postprandial glycemic and insulinemic response after consumption of 500 ml glucose-free apple juice compared to 500 ml untreated apple juice.
The second primary objective is to show the reduction of postprandial glycemic response after consumption of 250 ml glucose-free apple juice compared to 250 ml untreated apple juice.
The third primary objective is to show the reduction of insulinemic response after consumption of 250 ml glucose-free apple juice compared to 250 ml untreated apple juice.
Secondary objectives include safety aspects, specifically the occurrence of diarrhoea in all four treatment groups, differences between treatment groups on the Bristol Stool Forms Scale, gastro-intestinal symptoms and laboratory parameters. In addition, gluconate excretion and excreted portion of ingested gluconate are of interest as well as faecal pH.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- a double-blind randomised controlled cross-over trial
| Arm | Type | Receives |
|---|---|---|
| verum 500 | Active comparator | Other: 500 ml glucose-depleted apple juice500 ml low sugar apple juice manufactured from conventional apple juice via a series of enzymatic reactions that end up in a final content of free glucose less than 0,5 g/l. |
| control 500 | Placebo comparator | Other: 500 ml conventional apple juice500 ml conventional apple juice produced by a general apple juice production process (free glucose 17g/l) |
| verum 250 | Active comparator | Other: 250 ml glucose-depleted apple juice250 ml low sugar apple juice manufactured from conventional apple juice via a series of enzymatic reactions that end up in a final content of free glucose less than 0,5 g/l. |
| control 250 | Placebo comparator | Other: 250 ml conventional apple juice250 ml conventional apple juice produced by a general apple juice production process (free glucose 17g/l) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males aged ≥ 18y
- Impaired fasting glucose (IFG)
- Written informed consent
- Consent to collect stools and urine four times for three days
Key exclusion criteria (22 listed)
- Subjects currently enrolled in another clinical study
- Subjects having finished another clinical study within the last 4 weeks before inclusion.
- Subjects having participated in the study HB-RCT1-2015
- Hypersensitivity, allergy or idiosyncratic reaction to apple, apple juice or other apple containing food
- Acute or chronic infections
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 |
|---|---|---|
| 500 ml glucose-depleted apple juice | Other | verum 500 |
| 500 ml conventional apple juice | Other | control 500 |
| 250 ml glucose-depleted apple juice | Other | verum 250 |
| 250 ml conventional apple juice | Other | control 250 |
Primary outcome
iAUC glucose 500
Time frame: 120 min after ingestion
Incremental AUC (iAUC120) of blood glucose levels (according to FAO/WHO) after 500 ml juice
iAUC insulin 500
Time frame: 120 min after ingestion
iAUC insulin 500
iAUC glucose 250
Time frame: 120 min after ingestion
Incremental AUC (iAUC120) of blood glucose levels (according to FAO/WHO) after 250 ml juice
iAUC insulin 250
Time frame: 120 min after ingestion
iAUC insulin 250
2 secondary outcomes
diarrhea
Time frame: before and 60 and 120 minutes after ingestion with respect to the last 2 hours
gastro-intestinal symptoms
Time frame: before and 60 and 120 minutes after ingestion with respect to the last 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 4 Aug 2021.
- Individual participant dataSharing planned: No
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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.
Christiane Laue, Dr. (MD) principal investigator
CRC Clinical Research Center Kiel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 500 ml glucose-depleted apple juice, 500 ml conventional apple juice and 250 ml glucose-depleted apple juice in people with Prediabetes, run by Clinical Research Center Kiel GmbH at 1 site in Germany.
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 22 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 4 Aug 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 Germany. 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. Some participants in this study may receive a placebo. 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?
iAUC glucose 500 (time frame: 120 min after ingestion). The study lists 4 primary outcomes in all. 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 4 Aug 2021.