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Investigation of Milk Peptides on Postprandial Blood Glucose Profile

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ClinicalTrials.gov Identifier: NCT03932695
Recruitment Status : Completed
First Posted : May 1, 2019
Last Update Posted : May 14, 2019
Sponsor:
Information provided by (Responsible Party):
Ingredia S.A.

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Postprandial Hyperglycemia Dietary Supplement: Low dose milk peptide Dietary Supplement: High Dose milk peptide Dietary Supplement: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: double blind cross over and open for the phase II of the study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: first phase of the study is RCT double blind placebo cross-over. The second phase is open during 6 weeks of supplementation
Primary Purpose: Prevention
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
Actual Study Start Date : September 26, 2018
Actual Primary Completion Date : February 20, 2019
Actual Study Completion Date : April 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar

Arm Intervention/treatment
Active Comparator: High dose Milk peptides
2800mg of whey protein hydrolysates single dose
Dietary Supplement: High Dose milk peptide
what is the effect of milk peptides 2800mg on postprandial glycemia after a meal rich in carbohydrates (75g)

Active Comparator: Low dose Milk peptides
1400mg of whey protein hydrolysate Single dose and 6 weeks intervention
Dietary Supplement: Low dose milk peptide
what is the effect of milk peptides 1400mg on postprandial glycemia after a meal rich in carbohydrates (75g)

Placebo Comparator: Placebo
maltodextrin
Dietary Supplement: Placebo
what is the effect of placebo on postprandial glycemia after a meal rich in carbohydrates (75g)




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Cmax [ Time Frame: day 1, day 8, day 15, day 57 ]
    Maximum blood glucose concentration

  2. Max-Increase [ Time Frame: day 1, day 8, day 15, day 57 ]
    Cmax minus baseline value

  3. Tmax [ Time Frame: day 1, day 8, day 15, day 57 ]
    Time to reach maximum blood glucose concentration

  4. Tbaseline [ Time Frame: day 1, day 8, day 15, day 57 ]
    First time to reach baseline again after increase or decrease in blood glucose

  5. AUC(0-180min): [ Time Frame: day 1, day 8, day 15, day 57 ]
    Total area under curve from 0 to 180 min for blood glucose concentration

  6. Insulin-iAUC(0-180min) [ Time Frame: day 1, day 8, day 15, day 57 ]
    Area under the curve calculated as the incremental area under the Insulin response curve, ignoring the area beneath the fasting concentration

  7. Cmax Baseline Insulin Max_increase Insulin [ Time Frame: day 1, day 8, day 15, day 57 ]
    Max_increase Insulin Cmax minus baseline insulin value

  8. Tmax insulin [ Time Frame: day 1, day 8, day 15, day 57 ]
    time to reach maximum Insulin concentration

  9. Fasting glucose, fasting insulin [ Time Frame: Baseline and Day 57 ]
  10. HOMA index [ Time Frame: Baseline and Day 57 ]
    Parameters of insulin sensitivity:

  11. HbA1c level [ Time Frame: Baseline (V5) and Day 57 (after 6 weeks) ]
    HbA1c level after 6 weeks of supplementation

  12. Matsuda index [ Time Frame: Baseline and Day 57 ]
    Insulin sensitivity

  13. Quicki Index [ Time Frame: Baseline and Day 57 ]
    Insulin sensitivity



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03932695


Locations
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Germany
Biotesys
Esslingen, Germany
Sponsors and Collaborators
Ingredia S.A.
Investigators
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Principal Investigator: Audrey BOULIER, MD Ingredia S.A.

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Responsible Party: Ingredia S.A.
ClinicalTrials.gov Identifier: NCT03932695     History of Changes
Other Study ID Numbers: BTS1130/17
First Posted: May 1, 2019    Key Record Dates
Last Update Posted: May 14, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases