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

NCT03658681 | Completed

• 1 other identifier: 200642
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Postprandial Blood Glucose; Gut Microbiota; Satiety

Keywords

Fat quality; Blood glucose; Gut microbiota; Satiety; Dietary intervention

Outcome Measures

Primary Outcomes (2)

• Blood glucose response measured in capillary blood

  Blood glucose response after oral glucose tolerance test (OGTT) measured in Finger-prick capillary blood samples

  Change from baseline at day 4

• Serum Insulin response measured in venous blood samples

  Serum Insulin response after OGTT measured in venous blood samples

  Change from baseline at day 4

Secondary Outcomes (11)

• Hydrogen breath response measured in expired air

  Change from baseline at day 4

• Free fatty acids

  Change from baseline at day 4

• Microbiota analyses in feces

  Change from baseline at day 4

• Serum triglyceride response

  Change from baseline at day 4

• Serum cholesterol

  Change from baseline at day 4

Study Arms (2)

Test meal 1: Saturated fat 14.9 E%

EXPERIMENTAL

Test meal with saturated fat 14.9 E%

Other: Saturated fat 14.9 E%

Test meal 2: Polyunsaturated fat 13.6 E%

EXPERIMENTAL

Test meal with polyunsaturated fat 13,6 E%

Other: Polyunsaturated fat 13.6 E%

Interventions

Saturated fat 14.9 E% OTHER

Dietary cross-over study with saturated fat

Test meal 1: Saturated fat 14.9 E%

Polyunsaturated fat 13.6 E% OTHER

Dietary cross-over study with polyunsaturated fat

Test meal 2: Polyunsaturated fat 13.6 E%

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BMI between 18,5 and 27 kg/m2
• Fasting plasma glucose ≤ 6.1 mmol/l

You may not qualify if:

• 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)

Sponsors & Collaborators

• Oslo Metropolitan University: lead
• Mills DA: collaborator
• Nofima: collaborator
• University of Oslo: collaborator

Study Sites (1)

Oslo Metropolitan University

Oslo, 0130, Norway

Location

Related Publications (1)

• 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.

  PMID: 36163070 DERIVED

Study Officials

• Vibeke Telle-Hansen, PhD

  Oslo Metropolitan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Intervention with cross-over design. Two test meals will be tested.

Study Record Dates

• First Submitted: June 6, 2018
• First Posted: September 5, 2018
• Study Start: March 13, 2018
• Primary Completion: January 31, 2019
• Study Completion: December 31, 2019
• Last Updated: May 7, 2020

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)