Postprandial HyperglycemiaNCT03932695
Investigation of Milk Peptides on Postprandial Blood Glucose Profile
A study testing Low dose milk peptide and High Dose milk peptide in people with Postprandial Hyperglycemia, run by Ingredia S.A. at 1 site in Germany.
Trial summary
Aim of the study is to investigate the effect of two different dosages of milk peptides on postprandial blood glucose profile in prediabetic subjects compared to placebo. This will be investigated in a cross-over double blind randomized placebo controlled study design. Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Postprandial Hyperglycemia
- What is being tested?
- Low dose milk peptide and High Dose milk peptide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteGermany
- Study dates
- 26 Sep 2018to 30 Apr 2019
- 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 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female subjects with prediabetic HbA1c values between 5.7% - 6.4% and/or Fasting blood glucose ≥ 5.6 mmol/l (≥ 100 mg/dl) und < 7.0 mmol/l (< 125 mg/dl) (in venous plasma)
- Age: 30-70 years
- Body mass index 19-35 kg/m2
- Non-smoker
- Caucasian
- Availability and presence in the study unit for approx. 3.5 hours/ week for 3 times in a row with approx. 1 week of washout in between.
- 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
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- 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
- Participation in a clinical study with an investigational product within one month before start of study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of Milk Peptides on Postprandial Blood Glucose Profile: Randomized, Double-blind, Placebo-controlled, Cross-over Study With Different Dosages Followed by an Open-label Single Arm Phase to Estimate Long Term Effects
Aim of the study is to investigate the effect of two different dosages of milk peptides on postprandial blood glucose profile in prediabetic subjects compared to placebo. This will be investigated in a cross-over double blind randomized placebo controlled study design. Additionally, long term effects on glucose status, insulin sensitivity and postprandial blood glucose profile will be investigated in a follow up 6-week open label phase with the low dose only.
- Conditions
- Postprandial Hyperglycemia
- Being tested
- Low dose milk peptide, High Dose milk peptide, Placebo
- Medical subject headings
- Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low dose milk peptideDietary supplement
what is the effect of milk peptides 1400mg on postprandial glycemia after a meal rich in carbohydrates (75g)
High Dose milk peptideDietary supplement
what is the effect of milk peptides 2800mg on postprandial glycemia after a meal rich in carbohydrates (75g)
PlaceboDietary supplement
what is the effect of placebo on postprandial glycemia after a meal rich in carbohydrates (75g)
| Study group | Role | What they receive |
|---|---|---|
| High dose Milk peptides | Active comparator | 2800mg of whey protein hydrolysates single dose Receives: Dietary Supplement: High Dose milk peptide |
| Low dose Milk peptides | Active comparator | 1400mg of whey protein hydrolysate Single dose and 6 weeks intervention Receives: Dietary Supplement: Low dose milk peptide |
| Placebo | Placebo comparator | maltodextrin Receives: Dietary Supplement: Placebo |
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
Measured: day 1, day 8, day 15, day 57
Secondary outcomes (13)
Cmax
Maximum blood glucose concentration
Measured: day 1, day 8, day 15, day 57
Max-Increase
Cmax minus baseline value
Measured: day 1, day 8, day 15, day 57
Tmax
Time to reach maximum blood glucose concentration
Measured: day 1, day 8, day 15, day 57
Tbaseline
First time to reach baseline again after increase or decrease in blood glucose
Measured: day 1, day 8, day 15, day 57
AUC(0-180min):
Total area under curve from 0 to 180 min for blood glucose concentration
Measured: day 1, day 8, day 15, day 57
Insulin-iAUC(0-180min)
Area under the curve calculated as the incremental area under the Insulin response curve, ignoring the area beneath the fasting concentration
Measured: day 1, day 8, day 15, day 57
Cmax Baseline Insulin Max_increase Insulin
Max_increase Insulin Cmax minus baseline insulin value
Measured: day 1, day 8, day 15, day 57
Tmax insulin
time to reach maximum Insulin concentration
Measured: day 1, day 8, day 15, day 57
Fasting glucose, fasting insulin
Measured: Baseline and Day 57
HOMA index
Parameters of insulin sensitivity:
Measured: Baseline and Day 57
HbA1c level
HbA1c level after 6 weeks of supplementation
Measured: Baseline (V5) and Day 57 (after 6 weeks)
Matsuda index
Insulin sensitivity
Measured: Baseline and Day 57
Quicki Index
Insulin sensitivity
Measured: Baseline and Day 57
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2019
- Study start26 Sep 2018
- Primary completion20 Feb 2019
- Study completion30 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postprandial HyperglycemiaStudies 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
- double blind cross over and open for the phase II of the study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ingredia S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Audrey BOULIER, MD, Principal investigator, Ingredia S.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03932695
- Sponsor's protocol ID
- BTS1130/17
- Status last verified
- Apr 2019
- First submitted
- 24 Apr 2019
- Last updated
- 14 May 2019
- Results posted
- No
- 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 14 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Milk Peptides on Postprandial Blood Glucose Profile: Randomized, Double-blind, Placebo-controlled, Cross-over Study With Different Dosages Followed by an Open-label Single Arm Phase to Estimate Long Term Effects
- ClinicalTrials.gov ID
- NCT03932695
- Acronym / sponsor ID
- BTS1130/17
- Conditions
- Postprandial Hyperglycemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Ingredia S.A.Industry (pharma, biotech, devices)
- Study start
- 26 Sep 2018 (actual)
- Primary completion
- 20 Feb 2019 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 1 May 2019 (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.
Aim of the study is to investigate the effect of two different dosages of milk peptides on postprandial blood glucose profile in prediabetic subjects compared to placebo. This will be investigated in a cross-over double blind randomized placebo controlled study design. Additionally, long term effects on glucose status, insulin sensitivity and postprandial blood glucose profile will be investigated in a follow up 6-week open label phase with the low dose only.
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
- double blind cross over and open for the phase II of the study
| Arm | Type | Receives |
|---|---|---|
| High dose Milk peptides | Active comparator | Dietary Supplement: High Dose milk peptide2800mg of whey protein hydrolysates single dose |
| Low dose Milk peptides | Active comparator | Dietary Supplement: Low dose milk peptide1400mg of whey protein hydrolysate Single dose and 6 weeks intervention |
| Placebo | Placebo comparator | Dietary Supplement: Placebomaltodextrin |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male and female subjects with prediabetic HbA1c values between 5.7% - 6.4% and/or Fasting blood glucose ≥ 5.6 mmol/l (≥ 100 mg/dl) und < 7.0 mmol/l (< 125 mg/dl) (in venous plasma)
- Age: 30-70 years
- Body mass index 19-35 kg/m2
- Non-smoker
- Caucasian
Key exclusion criteria (18 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 |
|---|---|---|
| Low dose milk peptidewhat is the effect of milk peptides 1400mg on postprandial glycemia after a meal rich in carbohydrates (75g) | Dietary supplement | Low dose Milk peptides |
| High Dose milk peptidewhat is the effect of milk peptides 2800mg on postprandial glycemia after a meal rich in carbohydrates (75g) | Dietary supplement | High dose Milk peptides |
| Placebowhat is the effect of placebo on postprandial glycemia after a meal rich in carbohydrates (75g) | Dietary supplement | Placebo |
Primary outcome
Glucose-iAUC(0-180min)
Time frame: day 1, day 8, day 15, day 57
Area under the curve calculated as the incremental area under the blood glucose response curve, ignoring the area beneath the fasting concentration
13 secondary outcomes
Cmax
Time frame: day 1, day 8, day 15, day 57
Max-Increase
Time frame: day 1, day 8, day 15, day 57
Tmax
Time frame: day 1, day 8, day 15, day 57
Tbaseline
Time frame: day 1, day 8, day 15, day 57
AUC(0-180min):
Time frame: day 1, day 8, day 15, day 57
Insulin-iAUC(0-180min)
Time frame: day 1, day 8, day 15, day 57
Cmax Baseline Insulin Max_increase Insulin
Time frame: day 1, day 8, day 15, day 57
Tmax insulin
Time frame: day 1, day 8, day 15, day 57
Fasting glucose, fasting insulin
Time frame: Baseline and Day 57
HOMA index
Time frame: Baseline and Day 57
HbA1c level
Time frame: Baseline (V5) and Day 57 (after 6 weeks)
Matsuda index
Time frame: Baseline and Day 57
Quicki Index
Time frame: Baseline and Day 57
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 14 May 2019.
- 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.
Audrey BOULIER, MD principal investigator
Ingredia S.A.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low dose milk peptide and High Dose milk peptide in people with Postprandial Hyperglycemia, 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 18 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 14 May 2019. 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 8, day 15, day 57). 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 14 May 2019.