Prediabetic StateNCT05391854
Clinical Study to Assess the Long-term Effect of Pep2Dia® on Glucose Homeostasis in Prediabetic Subjects
A study testing Pep2dia in people with Prediabetic State, run by Ingredia S.A. at 1 site in Germany.
Trial summary
The goal is to assess the long-term effect of Pep2Dia® compared to placebo intake on blood glucose homeostasis. Respective improvements will be assessed by changes in glycated haemoglobin (HbA1c) before and after the 12-weeks intervention. 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
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 1 siteGermany
- Study dates
- 21 Jun 2022to 20 Jun 2023
- 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% and 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%)
- Age: 25-70 years
- Body mass index 19-35 kg/m2
- Current Non-smoker
- Availability and presence in the study units for approx. 3.5 hours/ week for 2 times.
- Signed informed consent form
- No changes in food habits or physical activity 3 months prior to screening and during the study
- If applicable, stable intake of chronic medication of at least 4 weeks
Who cannot join
- Subjects with diagnosed Type 2-Diabetes with medical treatment
- Presence of disease or drug(s) influencing digestion and absorption of nutrients
- Intake of medications known to affect glucose tolerance, e.g., diabetic medication SGLT-2 inhibitors, GLP-1 receptor agonists, steroids, protease inhibitors or antipsychotics
- 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 or renal disease or laboratory evidence of hepatic dysfunction (i.e. alkaline phosphatase, ALT, AST >3 x ULN)
- Acute gastrointestinal diseases including diarrhea and/or vomiting within the last 2 weeks
Show all 19Show fewer
- Known inflammatory or 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 food supplements known to affect glucose tolerance, e.g., cinnamon capsules, conjugated linoleic acids, omega-3 fatty acids
- Intake of antibiotics within 4 weeks before the test days
- Known alcohol abuse or drug abuse
- Pregnant or breast-feeding women
- Weight loss intervention or recent body weight change >5 kg during last 3 months
- Known or suspected allergy to any component of the investigational product(s) (e.g. milk protein)
- Blood donation within 4 weeks prior to Visit 1 or during the study
- Anticipating any planned changes in lifestyle for the duration of the study
- Participation in another clinical intervention study within the last 4 weeks and concurrent participation in another intervention clinical study
- Subject unable to co-operate adequately
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Study to Assess the Long-term Effect of Pep2Dia® on Glucose Homeostasis in Prediabetic Subjects: a 12-week Randomized, Multicenter, Double-blind, Placebo-controlled, Parallel Study
The goal is to assess the long-term effect of Pep2Dia® compared to placebo intake on blood glucose homeostasis. Respective improvements will be assessed by changes in glycated haemoglobin (HbA1c) before and after the 12-weeks intervention.
- Conditions
- Prediabetic State
- Being tested
- Pep2dia, Placebo
- 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
700 mg Pep2Dia® 15 min prior to breakfast and 700 mg Pep2Dia® 15 min prior to dinner
PlaceboDietary supplement
700 mg placebo 15 min prior to breakfast and 700 mg placebo 15 min prior to dinner
| Study group | Role | What they receive |
|---|---|---|
| Pep2dia | Active comparator | Not described Receives: Dietary Supplement: Pep2dia |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycated haemoglobin (HbA1c)
Change from baseline Glycated haemoglobin (HbA1c) at 3 months
Measured: Before treatment (baseline = day 0); at the end of the treatment (after 3 months = day 85)
Secondary outcomes (10)
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
Measured: Day 1; Day 85
Cmax
Maximum blood glucose concentration
Measured: Day 1; Day 85
Delta Cmax
Maximum increase of glucose (Cmax minus baseline value)
Measured: Day 1; Day 85
Tmax
Time to reach maximum blood glucose concentration
Measured: Day 1; Day 85
Tbaseline
First time to reach baseline again after increase or decrease in blood glucose
Measured: Day 1; Day 85
ISI 0-120min
Measured: Day 1; Day 85
hsCRP
Measured: Day 1; Day 85
GLP-1
Measured: Day 1; Day 85
Body composition measurement
Evaluation of the fat mass/lean mass ratio by bioelectrical impedance analysis
Measured: Day 1; Day 85
SF-12 (Short-fom 12)
Score from 12 to 60. Higher score mean a better outcome.
Measured: Day 1; Day 85
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2022
- Study start21 Jun 2022
- Primary completion5 May 2023
- Study completion20 Jun 2023
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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 128 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
- NCT05391854
- Sponsor's protocol ID
- BTS1777/21
- Status last verified
- Jun 2023
- First submitted
- 6 May 2022
- Last updated
- 28 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Assess the Long-term Effect of Pep2Dia® on Glucose Homeostasis in Prediabetic Subjects: a 12-week Randomized, Multicenter, Double-blind, Placebo-controlled, Parallel Study
- ClinicalTrials.gov ID
- NCT05391854
- Acronym / sponsor ID
- BTS1777/21
- Conditions
- Prediabetic State
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Ingredia S.A.Industry (pharma, biotech, devices)
- Collaborators
- BioTeSys GmbH
- Study start
- 21 Jun 2022 (actual)
- Primary completion
- 5 May 2023 (actual)
- Study completion
- 20 Jun 2023 (actual)
- First posted
- 26 May 2022 (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 assess the long-term effect of Pep2Dia® compared to placebo intake on blood glucose homeostasis. Respective improvements will be assessed by changes in glycated haemoglobin (HbA1c) before and after the 12-weeks intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pep2dia | Active comparator | Dietary Supplement: Pep2dia |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male and female subjects (minimum one third of each gender) with prediabetic HbA1c values between 5.7% and 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%)
- Age: 25-70 years
- Body mass index 19-35 kg/m2
- Current Non-smoker
- Availability and presence in the study units for approx. 3.5 hours/ week for 2 times.
Key exclusion criteria (19 listed)
- Subjects with diagnosed Type 2-Diabetes with medical treatment
- Presence of disease or drug(s) influencing digestion and absorption of nutrients
- Intake of medications known to affect glucose tolerance, e.g., diabetic medication SGLT-2 inhibitors, GLP-1 receptor agonists, steroids, protease inhibitors or antipsychotics
- 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 or renal disease or laboratory evidence of hepatic dysfunction (i.e. alkaline phosphatase, ALT, AST >3 x ULN)
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 |
|---|---|---|
| Pep2dia700 mg Pep2Dia® 15 min prior to breakfast and 700 mg Pep2Dia® 15 min prior to dinner | Dietary supplement | Pep2dia |
| Placebo700 mg placebo 15 min prior to breakfast and 700 mg placebo 15 min prior to dinner | Dietary supplement | Placebo |
Primary outcome
Glycated haemoglobin (HbA1c)
Time frame: Before treatment (baseline = day 0); at the end of the treatment (after 3 months = day 85)
Change from baseline Glycated haemoglobin (HbA1c) at 3 months
10 secondary outcomes
Glucose-iAUC(0-180min)
Time frame: Day 1; Day 85
Cmax
Time frame: Day 1; Day 85
Delta Cmax
Time frame: Day 1; Day 85
Tmax
Time frame: Day 1; Day 85
Tbaseline
Time frame: Day 1; Day 85
ISI 0-120min
Time frame: Day 1; Day 85
hsCRP
Time frame: Day 1; Day 85
GLP-1
Time frame: Day 1; Day 85
Body composition measurement
Time frame: Day 1; Day 85
SF-12 (Short-fom 12)
Time frame: Day 1; Day 85
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 28 Jun 2023.
Related trials for Prediabetic State
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
RecruitingObservational study
Food-i-Sense Analytics: Integrating AI Into Continuous Glucose Monitoring Data Analysis for Precision Nutrition.
Prediabetes (Insulin Resistance, Impaired Glucose Tolerance), Artificial Intelligence Mobile Application
RecruitingPhase 3
A Study of Orforglipron in Participants With Overweight at Risk of Development of Obesity-Related Complications or Progression to Class 1 Obesity
Overweight, Prediabetic State
Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
Recruiting
CGM-Enhanced DPP to Prevent Type 2 Diabetes in Adults With Prediabetes
PreDiabetes
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 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 8 inclusion and 19 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 28 Jun 2023. 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?
Glycated haemoglobin (HbA1c) (time frame: Before treatment (baseline = day 0); at the end of the treatment (after 3 months = day 85)). 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 28 Jun 2023.