Postprandial Blood GlucoseNCT03658681
Effect of Fat Quality on Glycemic Regulation and Gut Microbiota After a Short-time Intervention in Healthy Individuals
A study testing Saturated fat 14.9 E% and Polyunsaturated fat 13.6 E% in people with Postprandial Blood Glucose and Gut Microbiota, run by Oslo Metropolitan University at 1 site in Norway.
Trial summary
The overall aim is to investigate effects of saturated versus polyunsaturated fat on glycemic regulation and satiety in a postprandial study with healthy individuals. The potential effects will be related to changes in gut microbiota, the circulating levels of short chain fatty acids, inflammation and gene expression… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Postprandial Blood Glucose, Gut Microbiota, Satiety
- What is being tested?
- Saturated fat 14.9 E% and Polyunsaturated fat 13.6 E%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNorway
- Study dates
- 13 Mar 2018to 31 Dec 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI between 18,5 and 27 kg/m2
- Fasting plasma glucose ≤ 6.1 mmol/l
Who cannot join
- Chronic metabolic diseases such as diabetes type 1 and 2, coronary heart disease and cancer the last 6 months.
- Intestinal diseases such as chron's 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
Show all 14Show fewer
- 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, including probiotic products, fish oil etc. four weeks prior to study entry and throughout the study period
- Alcohol consumption > 40g / day
- Hormone treatments (except contraceptives)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fat Quality and Blood Glucose
The overall aim is to investigate effects of saturated versus polyunsaturated fat on glycemic regulation and satiety in a postprandial study with healthy individuals. The potential effects will be related to changes in gut microbiota, the circulating levels of short chain fatty acids, inflammation and gene expression in peripheral mononuclear blood cells.
Read the detailed description
The intervention study will have a randomized, double blinded, cross-over design with different test meals consisting of saturated or polyunsaturated fat. The amount of fat will be identical in the test meals, but the fat quality will vary. The test meals are in the form of muffin and spread.
All participants will consume two muffins and minimum 20 g of spread a day for three consecutive days, consisting of either a high proportion of saturated fat or a high proportion of polyunsaturated fat. At day one (visit 1 and 3) and day four (visit 2 and 4) of the intervention week, the participants will perform a postprandial glucose test (OGTT, 75 g glucose in 100 ml water) at Oslo Metropolitan University. Blood samples will be taken before and at different time points after the glucose test. One week prior to the intervention week and during "wash-out" (11 days), the participants will consume the control products which are high in saturated fat.
At the screening visit (visit 0) the participants will be asked to limit the intake of dietary fat and fiber from oat and barley one week prior to visit 1 and during the study. Otherwise, participants will be asked not to change their diet and exercise habits during the study period. Individuals fulfilling the inclusion criteria will also be invited to participate in a cross-sectional study for investigating the gut microbiota in a healthy population.
An OGTT will be performed at visit 1, 2, 3 and 4.
The participants will receive test meals after screening and before visit 1, 2, and 3.
- Conditions
- Postprandial Blood Glucose, Gut Microbiota, Satiety
- Being tested
- Saturated fat 14.9 E%, Polyunsaturated fat 13.6 E%
- Keywords
- Fat quality, Blood glucose, Gut microbiota, Satiety, Dietary intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saturated fat 14.9 E%Other
Dietary cross-over study with saturated fat
Polyunsaturated fat 13.6 E%Other
Dietary cross-over study with polyunsaturated fat
| Study group | Role | What they receive |
|---|---|---|
| Test meal 1: Saturated fat 14.9 E% | Experimental | Test meal with saturated fat 14.9 E% Receives: Other: Saturated fat 14.9 E% |
| Test meal 2: Polyunsaturated fat 13.6 E% | Experimental | Test meal with polyunsaturated fat 13,6 E% Receives: Other: Polyunsaturated fat 13.6 E% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood glucose response measured in capillary blood
Blood glucose response after oral glucose tolerance test (OGTT) measured in Finger-prick capillary blood samples
Measured: Change from baseline at day 4
Serum Insulin response measured in venous blood samples
Serum Insulin response after OGTT measured in venous blood samples
Measured: Change from baseline at day 4
Secondary outcomes (11)
Hydrogen breath response measured in expired air
Hydrogen breath response after OGTT measured in expired air by Gastroanalyzer
Measured: Change from baseline at day 4
Free fatty acids
Plasma free fatty acids are measured after intake of test meals
Measured: Change from baseline at day 4
Microbiota analyses in feces
Microbiota analyses in feces are measured before and after intake of test meals. Change in microbiota will be analysed
Measured: Change from baseline at day 4
Serum triglyceride response
Triglyceride response are measured are measured after OGTT
Measured: Change from baseline at day 4
Serum cholesterol
Serum cholesterol are measured fasting after intake of test meals
Measured: Change from baseline at day 4
Hunger and satiety hormones (e.g. GLP2, PYY)
The response in hunger and satiety hormones after OGTT
Measured: Change from baseline at day 4
Inflammatory markers (e.g. CRP)
Response in Inflammatory markers are measured after OGTT
Measured: Change from baseline at day 4
mRNA analyses in PBMC
PBMC are collected before and after OGTT. The change in mRNA level will be analyzed
Measured: Change from baseline at day 4
Quantitative assessment of metabolites in urine
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
Measured: Change from baseline at day 4
Quantitative assessment of metabolites in plasma
Plasma for metabolome analyses are collected after intake of test meals. Metabolites in plasma will be quantified using UHPLC-qTOF-MS
Measured: Change from baseline at day 4
Visual analogue scale (VAS)
Subjective hunger and satiety after OGTT and will be measured on a 100 mm horizontal line. Marks towards right end on line indicates strong sensation for hunger and satiety, whereas marks towards left end indicates opposite sensation. The distance from left border of line to the mark indicates subjective sensation.
Measured: Change from baseline at day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2018
- Study start13 Mar 2018
- Primary completion31 Jan 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postprandial Blood GlucoseStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Intervention with cross-over design. Two test meals will be tested.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo Metropolitan University
- Sponsor type
- University, hospital or other
- Collaborators
- Mills DA, Nofima, University of Oslo
- Responsible party
- Sponsor
- Investigators
- Vibeke Telle-Hansen, PhD, Principal investigator, Oslo Metropolitan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03658681
- Sponsor's protocol ID
- 200642
- Status last verified
- Dec 2019
- First submitted
- 6 Jun 2018
- Last updated
- 7 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Telle-Hansen VH, Gaundal L, Bastani N, Rud I, Byfuglien MG, Gjovaag T, Retterstol K, Holven KB, Ulven SM, Myhrstad MCW. Replacing saturated fatty acids with polyunsaturated fatty acids increases the abundance of Lachnospiraceae and is associated with reduced total cholesterol levels-a randomized controlled trial in healthy individuals. Lipids Health Dis. 2022 Sep 26;21(1):92. doi: 10.1186/s12944-022-01702-1.
PubMed 36163070
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fat Quality and Blood Glucose
- ClinicalTrials.gov ID
- NCT03658681
- Acronym / sponsor ID
- 200642
- Conditions
- Postprandial Blood Glucose, Gut Microbiota, Satiety
- Keywords
- Fat quality, Blood glucose, Gut microbiota, Satiety, Dietary intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Oslo Metropolitan UniversityUniversity, hospital or other
- Collaborators
- Mills DA, Nofima, University of Oslo
- Study start
- 13 Mar 2018 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 5 Sep 2018 (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 overall aim is to investigate effects of saturated versus polyunsaturated fat on glycemic regulation and satiety in a postprandial study with healthy individuals. The potential effects will be related to changes in gut microbiota, the circulating levels of short chain fatty acids, inflammation and gene expression in peripheral mononuclear blood cells.
Detailed description
The intervention study will have a randomized, double blinded, cross-over design with different test meals consisting of saturated or polyunsaturated fat. The amount of fat will be identical in the test meals, but the fat quality will vary. The test meals are in the form of muffin and spread.
All participants will consume two muffins and minimum 20 g of spread a day for three consecutive days, consisting of either a high proportion of saturated fat or a high proportion of polyunsaturated fat. At day one (visit 1 and 3) and day four (visit 2 and 4) of the intervention week, the participants will perform a postprandial glucose test (OGTT, 75 g glucose in 100 ml water) at Oslo Metropolitan University. Blood samples will be taken before and at different time points after the glucose test. One week prior to the intervention week and during "wash-out" (11 days), the participants will consume the control products which are high in saturated fat.
At the screening visit (visit 0) the participants will be asked to limit the intake of dietary fat and fiber from oat and barley one week prior to visit 1 and during the study. Otherwise, participants will be asked not to change their diet and exercise habits during the study period. Individuals fulfilling the inclusion criteria will also be invited to participate in a cross-sectional study for investigating the gut microbiota in a healthy population.
An OGTT will be performed at visit 1, 2, 3 and 4.
The participants will receive test meals after screening and before visit 1, 2, and 3.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Intervention with cross-over design. Two test meals will be tested.
| Arm | Type | Receives |
|---|---|---|
| Test meal 1: Saturated fat 14.9 E% | Experimental | Other: Saturated fat 14.9 E%Test meal with saturated fat 14.9 E% |
| Test meal 2: Polyunsaturated fat 13.6 E% | Experimental | Other: Polyunsaturated fat 13.6 E%Test meal with polyunsaturated fat 13,6 E% |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- BMI between 18,5 and 27 kg/m2
- Fasting plasma glucose ≤ 6.1 mmol/l
Key exclusion criteria (14 listed)
- Chronic metabolic diseases such as diabetes type 1 and 2, coronary heart disease and cancer the last 6 months.
- Intestinal diseases such as chron's disease, ulcerative colitis and irritable bowel syndrome.
- Food allergy and intolerances towards grain and dairy products.
- Pregnant and lactating
- Smokers
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 |
|---|---|---|
| Saturated fat 14.9 E%Dietary cross-over study with saturated fat | Other | Test meal 1: Saturated fat 14.9 E% |
| Polyunsaturated fat 13.6 E%Dietary cross-over study with polyunsaturated fat | Other | Test meal 2: Polyunsaturated fat 13.6 E% |
Primary outcome
Blood glucose response measured in capillary blood
Time frame: Change from baseline at day 4
Blood glucose response after oral glucose tolerance test (OGTT) measured in Finger-prick capillary blood samples
Serum Insulin response measured in venous blood samples
Time frame: Change from baseline at day 4
Serum Insulin response after OGTT measured in venous blood samples
11 secondary outcomes
Hydrogen breath response measured in expired air
Time frame: Change from baseline at day 4
Free fatty acids
Time frame: Change from baseline at day 4
Microbiota analyses in feces
Time frame: Change from baseline at day 4
Serum triglyceride response
Time frame: Change from baseline at day 4
Serum cholesterol
Time frame: Change from baseline at day 4
Hunger and satiety hormones (e.g. GLP2, PYY)
Time frame: Change from baseline at day 4
Inflammatory markers (e.g. CRP)
Time frame: Change from baseline at day 4
mRNA analyses in PBMC
Time frame: Change from baseline at day 4
Quantitative assessment of metabolites in urine
Time frame: Change from baseline at day 4
Quantitative assessment of metabolites in plasma
Time frame: Change from baseline at day 4
Visual analogue scale (VAS)
Time frame: Change from baseline at day 4
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 7 May 2020.
- Derived from this study: PubMed 36163070Telle-Hansen VH, Gaundal L, Bastani N, Rud I, Byfuglien MG, Gjovaag T, Retterstol K, Holven KB, Ulven SM, Myhrstad MCW. Replacing saturated fatty acids with polyunsaturated fatty acids increases the abundance of Lachnospiraceae and is associated with reduced total cholesterol levels-a randomized controlled trial in healthy individuals. Lipids Health Dis. 2022 Sep 26;21(1):92. doi: 10.1186/s12944-022-01702-1.
- 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.
Vibeke Telle-Hansen, PhD principal investigator
Oslo Metropolitan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Saturated fat 14.9 E% and Polyunsaturated fat 13.6 E% in people with Postprandial Blood Glucose and Gut Microbiota, run by Oslo Metropolitan University at 1 site in Norway.
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 2 inclusion and 14 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 7 May 2020. 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 Norway. 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. 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?
Blood glucose response measured in capillary blood (time frame: Change from baseline at day 4). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03658681, which also lists 1 linked publication.
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 7 May 2020.