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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

Tracking Information
First Submitted Date  ICMJE June 6, 2018
First Posted Date  ICMJE September 5, 2018
Last Update Posted Date April 3, 2019
Actual Study Start Date  ICMJE March 13, 2018
Actual Primary Completion Date January 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 17, 2018)
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: August 31, 2018)
  • Postprandial blood glucose response [ Time Frame: Change from baseline at day 4 ]
    Blood glucose response after OGTT
  • Postprandial insulin response [ Time Frame: Change from baseline at day 4 ]
    Insulin response after OGTT
Change History Complete list of historical versions of study NCT03658681 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 17, 2018)
  • 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
  • Free fatty acids [ Time Frame: Change from baseline at day 4 ]
    Plasma free fatty acids are measured after intake of test meals
  • 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
  • Serum triglyceride response [ Time Frame: Change from baseline at day 4 ]
    Triglyceride response are measured are measured after OGTT
  • Serum cholesterol [ Time Frame: Change from baseline at day 4 ]
    Serum cholesterol are measured fasting after intake of test meals
  • 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
  • Inflammatory markers (e.g. CRP) [ Time Frame: Change from baseline at day 4 ]
    Response in Inflammatory markers are measured after OGTT
  • 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
  • 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
  • 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
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 31, 2018)
  • H2 breath response [ Time Frame: Change from baseline at day 4 ]
    H2 breath response after OGTT
  • Free fatty acids [ Time Frame: Change from baseline at day 4 ]
    Plasma free fatty acids are measured after intake of test meals
  • 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
  • Serum triglyceride response [ Time Frame: Change from baseline at day 4 ]
    Triglyceride response are measured are measured after OGTT
  • Serum cholesterol [ Time Frame: Change from baseline at day 4 ]
    Serum cholesterol are measured fasting after intake of test meals
  • 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
  • Inflammatory markers (e.g. CRP) [ Time Frame: Change from baseline at day 4 ]
    Response in Inflammatory markers are measured after OGTT
  • 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
  • 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
  • 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
  • Visual analogue scale (VAS) [ Time Frame: Change from baseline at day 4 ]
    Subjective hunger and satiety will be estimated after OGTT.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Fat Quality on Glycemic Regulation and Gut Microbiota After a Short-time Intervention in Healthy Individuals
Official Title  ICMJE Fat Quality and Blood Glucose
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Postprandial Blood Glucose
  • Gut Microbiota
  • Satiety
Intervention  ICMJE
  • Other: Saturated fat 14.9 E%
    Dietary cross-over study with saturated fat
  • Other: Polyunsaturated fat 13.6 E%
    Dietary cross-over study with polyunsaturated fat
Study Arms  ICMJE
  • Experimental: Test meal 1: Saturated fat 14.9 E%
    Test meal with saturated fat 14.9 E%
    Intervention: Other: Saturated fat 14.9 E%
  • Experimental: Test meal 2: Polyunsaturated fat 13.6 E%
    Test meal with polyunsaturated fat 13,6 E%
    Intervention: Other: Polyunsaturated fat 13.6 E%
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: August 31, 2018)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2019
Actual Primary Completion Date January 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03658681
Other Study ID Numbers  ICMJE 200642
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Oslo and Akershus University College of Applied Sciences
Study Sponsor  ICMJE Oslo and Akershus University College of Applied Sciences
Collaborators  ICMJE
  • Mills DA
  • Nofima
  • University of Oslo
Investigators  ICMJE
Principal Investigator: Vibeke Telle-Hansen, PhD Oslo Metropolitan University
PRS Account Oslo and Akershus University College of Applied Sciences
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP