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Effect of Fat Quality on Glycemic Regulation and Gut Microbiota After a Short-time Intervention in Healthy Individuals

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ClinicalTrials.gov Identifier: NCT03658681
Recruitment Status : Active, not recruiting
First Posted : September 5, 2018
Last Update Posted : April 3, 2019
Sponsor:
Collaborators:
Mills DA
Nofima
University of Oslo
Information provided by (Responsible Party):
Oslo and Akershus University College of Applied Sciences

Brief 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 in peripheral mononuclear blood cells.

Condition or disease Intervention/treatment Phase
Postprandial Blood Glucose Gut Microbiota Satiety Other: Saturated fat 14.9 E% Other: Polyunsaturated fat 13.6 E% Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Intervention with cross-over design. Two test meals will be tested.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Fat Quality and Blood Glucose
Actual Study Start Date : March 13, 2018
Actual Primary Completion Date : January 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar

Arm Intervention/treatment
Experimental: Test meal 1: Saturated fat 14.9 E%
Test meal with saturated fat 14.9 E%
Other: Saturated fat 14.9 E%
Dietary cross-over study with saturated fat

Experimental: Test meal 2: Polyunsaturated fat 13.6 E%
Test meal with polyunsaturated fat 13,6 E%
Other: Polyunsaturated fat 13.6 E%
Dietary cross-over study with polyunsaturated fat




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. Hydrogen breath response measured in expired air [ Time Frame: Change from baseline at day 4 ]
    Hydrogen breath response after OGTT measured in expired air by Gastroanalyzer

  2. Free fatty acids [ Time Frame: Change from baseline at day 4 ]
    Plasma free fatty acids are measured after intake of test meals

  3. Microbiota analyses in feces [ Time Frame: Change from baseline at day 4 ]
    Microbiota analyses in feces are measured before and after intake of test meals. Change in microbiota will be analysed

  4. Serum triglyceride response [ Time Frame: Change from baseline at day 4 ]
    Triglyceride response are measured are measured after OGTT

  5. Serum cholesterol [ Time Frame: Change from baseline at day 4 ]
    Serum cholesterol are measured fasting after intake of test meals

  6. Hunger and satiety hormones (e.g. GLP2, PYY) [ Time Frame: Change from baseline at day 4 ]
    The response in hunger and satiety hormones after OGTT

  7. Inflammatory markers (e.g. CRP) [ Time Frame: Change from baseline at day 4 ]
    Response in Inflammatory markers are measured after OGTT

  8. mRNA analyses in PBMC [ Time Frame: Change from baseline at day 4 ]
    PBMC are collected before and after OGTT. The change in mRNA level will be analyzed

  9. Quantitative assessment of metabolites in urine [ Time Frame: Change from baseline 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

  10. Quantitative assessment of metabolites in plasma [ Time Frame: Change from baseline at day 4 ]
    Plasma for metabolome analyses are collected after intake of test meals. Metabolites in plasma will be quantified using UHPLC-qTOF-MS

  11. Visual analogue scale (VAS) [ Time Frame: Change from baseline at day 4 ]
    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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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 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
  • 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)

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): NCT03658681


Locations
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Norway
Oslo Metropolitan University
Oslo, Norway, 0130
Sponsors and Collaborators
Oslo and Akershus University College of Applied Sciences
Mills DA
Nofima
University of Oslo
Investigators
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Principal Investigator: Vibeke Telle-Hansen, PhD Oslo Metropolitan University

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Responsible Party: Oslo and Akershus University College of Applied Sciences
ClinicalTrials.gov Identifier: NCT03658681     History of Changes
Other Study ID Numbers: 200642
First Posted: September 5, 2018    Key Record Dates
Last Update Posted: April 3, 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
Keywords provided by Oslo and Akershus University College of Applied Sciences:
Fat quality
Blood glucose
Gut microbiota
Satiety
Dietary intervention