Impaired Fasting GlucoseNCT02542033
Glycemic Response to Low Sugar Apple Juice
A study testing treated apple juice with low sugar content and un-treated apple juice with normal sugar content in people with Impaired Fasting Glucose, run by Clinical Research Center Kiel GmbH at 1 site in Germany.
Trial summary
Primary objective of this study is to investigate the effect of sugar reduction (starting from glucose and sucrose, respectively) on postprandial glycemic response to apple juice by comparing the reference food item apple juice (control) with the test product (apple juice with low sugar content) in male humans with… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Impaired Fasting Glucose
- What is being tested?
- treated apple juice with low sugar content and un-treated apple juice with normal sugar content
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- May 2015to Nov 2015
- 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
- diagnosed impaired fasting glucose (IFG)
- Written informed consent
Who cannot join
- Subjects currently enrolled in another clinical study
- Subjects having finished another clinical study within the last 4 weeks before inclusion
- Hypersensitivity, allergy or idiosyncratic reaction to apple, apple juice or other apple containing food
- Acute or chronic infections
- Renal insufficiency
- Gastrointestinal illness
Show all 20Show fewer
- 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. 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
Clinical Research Center (CRC) Kiel GmbH
Kiel, Schleswig-Holstein, 24118
About this study
Official title: Double-blind, Randomized, Controlled, Cross-over Trial on Glycemic Response to Low Sugar Apple Juice
Primary objective of this study is to investigate the effect of sugar reduction (starting from glucose and sucrose, respectively) on postprandial glycemic response to apple juice by comparing the reference food item apple juice (control) with the test product (apple juice with low sugar content) in male humans with impaired fasting glucose (IFG) (5.6-6.9mmol/l resp. 100-125mg/dL) (Kerner and Brückel, 2012 (DDG recommendation)) Secondary objective of this study is to investigate the effect of sugar reduction on postprandial insulinemic response.
Exploratory objectives are to investigate further characteristics of postprandial glucose and insulin response and insulin sensitivity, gastrointestinal side effects and safety aspects.
Read the detailed description
Objectives:
Investigating the effect of sugar reduction in apple juice on glycemic and insulin response to ingestion of this drink.
Subjects/Methods:
In a double-blind randomized placebo-controlled clinical trial with cross-over design 30 male adults with impaired fasting glucose (IFG) received an oral drink of 500mL: 1. Verum: Apple juice, treated (low sugar content); 2. Control: Untreated apple juice (normal sugar content). Capillary blood glucose and venous plasma insulin were measured twice at baseline and then at times 0 (start of drink), 15, 30, 45, 60, 90 and 120 min.
- Conditions
- Impaired Fasting Glucose
- Being tested
- treated apple juice with low sugar content, un-treated apple juice with normal sugar content
- Keywords
- postprandial glycemia; apple juice; sugar reduction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
treated apple juice with low sugar contentOther
Each study participant consumed 500 mL test juice at the morning of the interventional day. The 500 mL bottle content had to be ingested within 5 minutes. an intravenous catheter was inserted into a forearm vein for blood withdrawal at baseline, directly before (time point 0) and 15, 30, 45, 60, 90 and 120 minutes after starting the ingestion of the test product. From all samples plasma insulin was measured. From the blood samples taken at baseline and 120 minutes after consumption of the test product safety parameters were determined. Capillary blood was taken from the finger pad using a HemoCue® Safety Lancet at baseline (twice) and once directly before (time point 0) and 15, 30, 45, 60, 90 and 120 minutes after ingestion of the test product.
un-treated apple juice with normal sugar contentOther
Each study participant consumed 500 mL test juice at the morning of the interventional day. The 500 mL bottle content had to be ingested within 5 minutes. an intravenous catheter was inserted into a forearm vein for blood withdrawal at baseline, directly before (time point 0) and 15, 30, 45, 60, 90 and 120 minutes after starting the ingestion of the test product. From all samples plasma insulin was measured. From the blood samples taken at baseline and 120 minutes after consumption of the test product safety parameters were determined. Capillary blood was taken from the finger pad using a HemoCue® Safety Lancet at baseline (twice) and once directly before (time point 0) and 15, 30, 45, 60, 90 and 120 minutes after ingestion of the test product.
| Study group | Role | What they receive |
|---|---|---|
| verum | Active comparator | 500mL treated apple juice with low sugar content given on one experimental day Receives: Other: treated apple juice with low sugar content |
| control | Placebo comparator | 500mL un-treated apple juice with normal sugar content given on one experimental day Receives: Other: un-treated apple juice with normal sugar content |
What is being measured
The primary outcome is the main question the study is designed to answer.
incremental area under the postprandial glucose curve
Measured: 120 min postprandially
Secondary outcomes (1)
incremental area under the postprandial insulin curve
Measured: 120 min postprandially
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2015 (estimated)
- Study startMay 2015
- Primary completionAug 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impaired Fasting GlucoseStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinical Research Center Kiel GmbH
- Sponsor type
- University, hospital or other
- Collaborators
- Nofima
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02542033
- Sponsor's protocol ID
- HB-RCT1-2015
- Status last verified
- Sep 2015
- First submitted
- 3 Sep 2015
- Last updated
- 11 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Randomized, Controlled, Cross-over Trial on Glycemic Response to Low Sugar Apple Juice
- ClinicalTrials.gov ID
- NCT02542033
- Acronym / sponsor ID
- HB-RCT1-2015
- Conditions
- Impaired Fasting Glucose
- Keywords
- postprandial glycemia; apple juice; sugar reduction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Clinical Research Center Kiel GmbHUniversity, hospital or other
- Collaborators
- Nofima
- Study start
- May 2015
- Primary completion
- Aug 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 4 Sep 2015 (estimated)
- 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.
Primary objective of this study is to investigate the effect of sugar reduction (starting from glucose and sucrose, respectively) on postprandial glycemic response to apple juice by comparing the reference food item apple juice (control) with the test product (apple juice with low sugar content) in male humans with impaired fasting glucose (IFG) (5.6-6.9mmol/l resp. 100-125mg/dL) (Kerner and Brückel, 2012 (DDG recommendation)) Secondary objective of this study is to investigate the effect of sugar reduction on postprandial insulinemic response.
Exploratory objectives are to investigate further characteristics of postprandial glucose and insulin response and insulin sensitivity, gastrointestinal side effects and safety aspects.
Detailed description
Objectives:
Investigating the effect of sugar reduction in apple juice on glycemic and insulin response to ingestion of this drink.
Subjects/Methods:
In a double-blind randomized placebo-controlled clinical trial with cross-over design 30 male adults with impaired fasting glucose (IFG) received an oral drink of 500mL: 1. Verum: Apple juice, treated (low sugar content); 2. Control: Untreated apple juice (normal sugar content). Capillary blood glucose and venous plasma insulin were measured twice at baseline and then at times 0 (start of drink), 15, 30, 45, 60, 90 and 120 min.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| verum | Active comparator | Other: treated apple juice with low sugar content500mL treated apple juice with low sugar content given on one experimental day |
| control | Placebo comparator | Other: un-treated apple juice with normal sugar content500mL un-treated apple juice with normal sugar content given on one experimental day |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Males aged ≥ 18y
- diagnosed impaired fasting glucose (IFG)
- Written informed consent
Key exclusion criteria (20 listed)
- Subjects currently enrolled in another clinical study
- Subjects having finished another clinical study within the last 4 weeks before inclusion
- Hypersensitivity, allergy or idiosyncratic reaction to apple, apple juice or other apple containing food
- Acute or chronic infections
- Renal insufficiency
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 |
|---|---|---|
| treated apple juice with low sugar contentEach study participant consumed 500 mL test juice at the morning of the interventional day. The 500 mL bottle content had to be ingested within 5 minutes. an intravenous catheter was inserted into a forearm vein for blood withdrawal at baseline, directly before (time point 0) and 15, 30, 45, 60, 90 and 120 minutes after starting the ingestion of the test product. From all samples plasma insulin was measured. From the blood samples taken at baseline and 120 minutes after consumption of the test product safety parameters were determined. Capillary blood was taken from the finger pad using a HemoCue® Safety Lancet at baseline (twice) and once directly before (time point 0) and 15, 30, 45, 60, 90 and 120 minutes after ingestion of the test product. | Other | verum |
| un-treated apple juice with normal sugar contentEach study participant consumed 500 mL test juice at the morning of the interventional day. The 500 mL bottle content had to be ingested within 5 minutes. an intravenous catheter was inserted into a forearm vein for blood withdrawal at baseline, directly before (time point 0) and 15, 30, 45, 60, 90 and 120 minutes after starting the ingestion of the test product. From all samples plasma insulin was measured. From the blood samples taken at baseline and 120 minutes after consumption of the test product safety parameters were determined. Capillary blood was taken from the finger pad using a HemoCue® Safety Lancet at baseline (twice) and once directly before (time point 0) and 15, 30, 45, 60, 90 and 120 minutes after ingestion of the test product. | Other | control |
Primary outcome
incremental area under the postprandial glucose curve
Time frame: 120 min postprandially
1 secondary outcome
incremental area under the postprandial insulin curve
Time frame: 120 min postprandially
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 11 Feb 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing treated apple juice with low sugar content and un-treated apple juice with normal sugar content in people with Impaired Fasting Glucose, 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 3 inclusion and 20 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 11 Feb 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?
incremental area under the postprandial glucose curve (time frame: 120 min postprandially). 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 11 Feb 2021.