Prediabetic StateNCT04375449
Investigation of Milk Peptides (Pep2Dia®) on Postprandial Blood Glucose Profile in Prediabetic Subjects
A study testing Pep2dia and maltodextrin in people with Prediabetic State, run by Ingredia S.A. at 1 site in Germany.
Trial summary
The goal is to investigate the 180 min postprandial response on blood glucose and insulin levels after intake of Pep2Dia® in two different dosages compared to placebo in the context of a meal challenge test, providing 75 g of carbohydrates. Pep2Dia® will be administered 15 min prior to a standardized challenge meal. Read more about this study
- Who is it for?
- Ages 25 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Prediabetic State
- What is being tested?
- Pep2dia and maltodextrin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteGermany
- Study dates
- 4 May 2020to 15 Dec 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 25 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female subjects (minimum one third of each gender) with prediabetic HbA1c values between 5.7% - 6.4% and/or fasting glucose ≥ 5.6 mmol/L (≥ 100 mg/dL) and < 7.0 mmol/L (< 125 mg/dL) (in venous plasma) (twice confirmed at two independent days if HbA1c is < 5.7%)
- Body mass index 19-35 kg/m2
- Non-smoker
- Caucasian
- Availability and presence in the study units for approx. 3.5 hours/ week for 3 times.
- Signed informed consent form
- No changes in food habits or physical activity 3 months prior to screening and during the study
Who cannot join
- Presence of disease or drug(s) influencing digestion and absorption of nutrients or bowel habits
- Intake of medications known to affect glucose tolerance, e.g., diabetic medication, steroids, protease inhibitors or antipsychotics
- Diagnosed Typ 2-Diabetics with medical treatment
- Chronic intake of substances affecting blood coagulation (e.g. acetylic acid (100 mg as standard prophylactic treatment allowed when dose is stable 1 month prior to screening), anticoagulants, diuretics, thiazides (diuretics and thiazides allowed e.g. for hypertension treatment when dose is stable 1 month prior to screening)), which in the Investigator's opinion would impact patient safety
- Severe liver, renal or cardiac disease
- Acute gastrointestinal diseases including diarrhea and/or vomiting within the last 2 weeks
Show all 17Show fewer
- Known inflammatory and malignant gastrointestinal diseases (i.e. colitis ulcerosa, Morbus Crohn, celiac disease, malignant diseases e.g. colon-cancer, rectum cancer, pancreatitis)
- Clinically relevant findings as established by medical history, physical examination, clinical laboratory and/or vital signs
- Major medical or surgical event requiring hospitalization within the previous 3 months
- Intake of antibiotics within 4 weeks before the test days
- Known alcohol abuse or drug abuse
- Pregnant or breast feeding women
- Known or suspected allergy to any component of the investigational product(s) (e.g. milk protein)
- Known HIV-infection
- Known acute or chronic hepatitis B and C infection
- Blood donation within 4 weeks prior to visit 1 or during the study
- Subject unable to co-operate adequately
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of Milk Peptides (Pep2Dia®) on Postprandial Blood Glucose Profile in Prediabetic Subjects: Randomized, Double-blind, Placebo-controlled, Cross-over Study With Different Dosages
The goal is to investigate the 180 min postprandial response on blood glucose and insulin levels after intake of Pep2Dia® in two different dosages compared to placebo in the context of a meal challenge test, providing 75 g of carbohydrates. Pep2Dia® will be administered 15 min prior to a standardized challenge meal.
Read the detailed description
From a previous pilot study (BTS1130/17) there is first evidence that the native whey product with alpha-glucosidase inhibiting properties (Pep2Dia®) has the potential to modulate postprandial hyperglycaemia in prediabetic subjects.
Thereby, incremental areas under the curve (iAUC) of glucose as the primary outcome were significantly reduced by a single dosage of 1400 mg Pep2Dia® compared to placebo the second study is to investigate the 180 min postprandial response on blood glucose and insulin levels after intake of Pep2Dia® in two different dosages compared to placebo in the context of a meal challenge test, providing 75 g of carbohydrates. Pep2Dia® will be administered 15 min prior to a standardized challenge meal. Furthermore, the 120 min postprandial incretin response in terms of Glucagon-like Peptide-1 (GLP-1) will be determined. Changes in insulin sensitivity will be determined by the Matsuda-index as appropriate outcome measure.
- Conditions
- Prediabetic State
- Being tested
- Pep2dia, maltodextrin
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pep2diaDietary supplement
what is the effect of Pep2dia on postprandial glycemia after a meal rich in carbohydrates (75g)
maltodextrinDietary supplement
maltodextrin
| Study group | Role | What they receive |
|---|---|---|
| Pep2dia- dosage 1 | Active comparator | 700mg of whey protein hydrolysates single dose Receives: Dietary Supplement: Pep2dia |
| Pep2Dia - dosage 2 | Active comparator | 1400mg of whey protein hydrolysates single dose Receives: Dietary Supplement: Pep2dia |
| Placebo | Placebo comparator | maltodextrin single dose Receives: Dietary Supplement: maltodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose-iAUC(0-180min)
Area under the curve calculated as the incremental area under the blood glucose response curve, ignoring the area beneath the fasting concentration (according to ISO 26642:2010(E)
Measured: Day 1, Day 15, Day 29
Secondary outcomes (8)
Cmax
Maximum blood glucose concentration
Measured: Day 1, Day 15, Day 29
Max_increase
Cmax minus baseline value
Measured: Day 1, Day 15, Day 29
Tmax
Time to reach maximum blood glucose concentration
Measured: Day 1, Day 15, Day 29
Tbaseline
First time to reach baseline again after increase or decrease in blood glucose
Measured: Day 1, Day 15, Day 29
AUC(0-180min)
Total area under curve from 0 to 180 min for blood glucose concentration
Measured: Day 1, Day 15, Day 29
Matsuda index
Marker of insulin sensitivity
Measured: Day 1, Day 15, Day 29
Increase of insulin
Area under the curve calculated as the incremental area under the Insulin response curve, ignoring the area beneath the fasting concentration (Insulin-iAUC(0-180min)). If applicable further pharmacokinetic data from insulin increase will be calculated (e.g. Cmax, Tmax)
Measured: Day 1, Day 15, Day 29
GLP-1-iAUC(0-120min)
120 min postprandial incretin response in terms of Glucagon-like Peptide-1
Measured: Day 1, Day 15, Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2020
- Study start4 May 2020
- Primary completion25 Jul 2020
- Study completion15 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prediabetic StateStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The study will be performed as a multicentric, randomized, double-blind, and placebo-controlled in a 3-way cross-over design.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ingredia S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- BioTeSys GmbH
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04375449
- Sponsor's protocol ID
- BTS1472/20
- Status last verified
- May 2022
- First submitted
- 1 May 2020
- Last updated
- 11 May 2022
- 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 11 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Milk Peptides (Pep2Dia®) on Postprandial Blood Glucose Profile in Prediabetic Subjects: Randomized, Double-blind, Placebo-controlled, Cross-over Study With Different Dosages
- ClinicalTrials.gov ID
- NCT04375449
- Acronym / sponsor ID
- BTS1472/20
- Conditions
- Prediabetic State
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Ingredia S.A.Industry (pharma, biotech, devices)
- Collaborators
- BioTeSys GmbH
- Study start
- 4 May 2020 (actual)
- Primary completion
- 25 Jul 2020 (actual)
- Study completion
- 15 Dec 2020 (actual)
- First posted
- 5 May 2020 (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.
The goal is to investigate the 180 min postprandial response on blood glucose and insulin levels after intake of Pep2Dia® in two different dosages compared to placebo in the context of a meal challenge test, providing 75 g of carbohydrates. Pep2Dia® will be administered 15 min prior to a standardized challenge meal.
Detailed description
From a previous pilot study (BTS1130/17) there is first evidence that the native whey product with alpha-glucosidase inhibiting properties (Pep2Dia®) has the potential to modulate postprandial hyperglycaemia in prediabetic subjects.
Thereby, incremental areas under the curve (iAUC) of glucose as the primary outcome were significantly reduced by a single dosage of 1400 mg Pep2Dia® compared to placebo the second study is to investigate the 180 min postprandial response on blood glucose and insulin levels after intake of Pep2Dia® in two different dosages compared to placebo in the context of a meal challenge test, providing 75 g of carbohydrates. Pep2Dia® will be administered 15 min prior to a standardized challenge meal. Furthermore, the 120 min postprandial incretin response in terms of Glucagon-like Peptide-1 (GLP-1) will be determined. Changes in insulin sensitivity will be determined by the Matsuda-index as appropriate outcome measure.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- The study will be performed as a multicentric, randomized, double-blind, and placebo-controlled in a 3-way cross-over design.
| Arm | Type | Receives |
|---|---|---|
| Pep2dia- dosage 1 | Active comparator | Dietary Supplement: Pep2dia700mg of whey protein hydrolysates single dose |
| Pep2Dia - dosage 2 | Active comparator | Dietary Supplement: Pep2dia1400mg of whey protein hydrolysates single dose |
| Placebo | Placebo comparator | Dietary Supplement: maltodextrinmaltodextrin single dose |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male and female subjects (minimum one third of each gender) with prediabetic HbA1c values between 5.7% - 6.4% and/or fasting glucose ≥ 5.6 mmol/L (≥ 100 mg/dL) and < 7.0 mmol/L (< 125 mg/dL) (in venous plasma) (twice confirmed at two independent days if HbA1c is < 5.7%)
- Body mass index 19-35 kg/m2
- Non-smoker
- Caucasian
- Availability and presence in the study units for approx. 3.5 hours/ week for 3 times.
Key exclusion criteria (17 listed)
- Presence of disease or drug(s) influencing digestion and absorption of nutrients or bowel habits
- Intake of medications known to affect glucose tolerance, e.g., diabetic medication, steroids, protease inhibitors or antipsychotics
- Diagnosed Typ 2-Diabetics with medical treatment
- Chronic intake of substances affecting blood coagulation (e.g. acetylic acid (100 mg as standard prophylactic treatment allowed when dose is stable 1 month prior to screening), anticoagulants, diuretics, thiazides (diuretics and thiazides allowed e.g. for hypertension treatment when dose is stable 1 month prior to screening)), which in the Investigator's opinion would impact patient safety
- Severe liver, renal or cardiac disease
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 |
|---|---|---|
| Pep2diawhat is the effect of Pep2dia on postprandial glycemia after a meal rich in carbohydrates (75g) | Dietary supplement | Pep2Dia - dosage 2, Pep2dia- dosage 1 |
| maltodextrinmaltodextrin | Dietary supplement | Placebo |
Primary outcome
Glucose-iAUC(0-180min)
Time frame: Day 1, Day 15, Day 29
Area under the curve calculated as the incremental area under the blood glucose response curve, ignoring the area beneath the fasting concentration (according to ISO 26642:2010(E)
8 secondary outcomes
Cmax
Time frame: Day 1, Day 15, Day 29
Max_increase
Time frame: Day 1, Day 15, Day 29
Tmax
Time frame: Day 1, Day 15, Day 29
Tbaseline
Time frame: Day 1, Day 15, Day 29
AUC(0-180min)
Time frame: Day 1, Day 15, Day 29
Matsuda index
Time frame: Day 1, Day 15, Day 29
Increase of insulin
Time frame: Day 1, Day 15, Day 29
GLP-1-iAUC(0-120min)
Time frame: Day 1, Day 15, Day 29
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 May 2022.
- 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.
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 Pep2dia and maltodextrin in people with Prediabetic State, run by Ingredia S.A. 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 7 inclusion and 17 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 May 2022. 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?
Glucose-iAUC(0-180min) (time frame: Day 1, Day 15, Day 29). 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 May 2022.