- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03293693
Intake of Beta-glucan and Postprandial Regulation of Blood Glucose Metabolism in Healthy Subjects
Beta-glucan and Blood Glucose
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The intervention study will have a fixed order, cross-over design with three test meals containing low (0.5 g / 100 g of product), medium (3.5 g / 100 g of product) and high (8 g / 100 g product) amount of beta -glucans, respectively. The test meals are in the form of cereals. All participants will eat the three test meals three constitutive days with 2 weeks apart. At day four, the participants will perform a postprandial glucose test (OGTT, 75 g glucose in 150 ml water) at Oslo and Akershus University College. Blood samples will be taken before and at different time points after glucose test.
At the screening visit the participants will be asked to limit the intake of dietary fiber from grains two weeks prior to the baseline visit (0) and during the study. Otherwise, participants will be asked not to change their diet and exercise habits during the study period.
At the baseline visit (visit 0) an OGTT will be performed. OGTT will also be performed at visit 1, 3 and 5 after intake of low, medium and high beta-glucan, respectively.
The participants will receive the test meals at visit 1, 2 and 4.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Oslo, Norway, 0130
- Oslo and Akershus University College
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- BMI between 18,5 and 27 kg/m2
- Fasting plasma glucose ≤ 6.1 mmol/l
Exclusion Criteria:
- Chronic metabolic diseases such as diabetes type 1 and 2, coronary heart disease and cancer the last 6 months.
- Intestinal diseases such as chrons disease, ulcerative colitis and irritable bowel syndrome.
- Food allergy and intolerances towards grain and dairy products.
- Pregnant and lactating
- Smokers
- Fasting blood glucose ≥ 6.1 mmol/L
- CRP > 10 mg/L, measured at baseline (visit 0)
- BMI <18,5 and >27 kg/m2
- Planned weight reduction and or ± 5% weight change over the past three months.
- Use of antibiotics last 3 months before study entry and during the study period
- Use of probiotics the last month before study entry and during the study period
- Blood donor last 2 months before study entry and or during the study period
- Not willing to end the use of dietary supplements four weeks prior to study entry and throughout the study period
- Alcohol consumption > 40g / day
- Hormone treatments (except contraceptives)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Test meal 1
Test meal with 0.5 g beta-glucan
|
Dietary cross-over study with beta-glucan fiber
|
Experimental: Test meal 2
Test meal with 3.5 g beta-glucan
|
Dietary cross-over study with beta-glucan fiber
|
Experimental: Test meal 3
Test meal with 8 g beta-glucan
|
Dietary cross-over study with beta-glucan fiber
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postprandial blood glucose response
Time Frame: At day 4
|
Blood glucose response after OGTT
|
At day 4
|
Postprandial insulin response
Time Frame: At day 4
|
insulin response after OGTT
|
At day 4
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
H2 breath response
Time Frame: At day 4
|
H2 breath response after OGTT
|
At day 4
|
Free fatty acids
Time Frame: At day 4
|
Plasma free fatty acids are measured after intake of test meals
|
At day 4
|
Microbiota analyses in feces
Time Frame: At day 4
|
Microbiota analyses in feces are measured before and after intake of test meals.
Change in microbiota will be analysed
|
At day 4
|
Serum triglyceride response
Time Frame: At day 4
|
Triglyceride response are measured are measured after OGTT
|
At day 4
|
Serum cholesterol
Time Frame: At day 4
|
Serum cholesterol are measured fasting after intake of test meals
|
At day 4
|
hunger and satiety hormones (e.g. GLP1)
Time Frame: At day 4
|
The response in hunger and satiety hormones after OGTT
|
At day 4
|
Inflammatory markers (e.g. CRP)
Time Frame: At day 4
|
Response in Inflammatory markers are measured after OGTT
|
At day 4
|
mRNA analyses in PBMC (RT-PCR)
Time Frame: At day 4
|
PBMC are collected before and after OGTT.
The change in mRNA level will be analyzed
|
At day 4
|
Quantitative assessment of metabolites in urine
Time Frame: At day 4
|
Morning urine are collected before and after intake of test meals.
Metabolites in urine will be quantified using UHPLC-qTOF-MS.
Change in metabolites before and after test meals will be analyzed
|
At day 4
|
Quantitative assessment of metabolites in plasma
Time Frame: At day 4
|
Plasma for metabolome analyses are collected after intake of test meals.
Metabolites in plasma will be quantified using UHPLC-qTOF-MS.
|
At day 4
|
Visual analogue scale (VAS)
Time Frame: At day 1
|
Subjective hunger and satiety will be estimated after intake of test meals for one day
|
At day 1
|
Visual analogue scale (VAS)
Time Frame: At day 3
|
Subjective hunger and satiety will be estimated after intake of test meals for three days
|
At day 3
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mari CW Myhrstad, PhD, Oslo and Akershus University College
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2016/648
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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