Effects of Plant Polar Lipids on Glucose Tolerance

NCT06148974 | Completed

• 1 other identifier: Prot.2018/8-23
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

In this randomized controlled trial, two different plant polar lipids are investigated with respect to their potential to affect acute and second meal glucose tolerance and appetite sensations. The effects are compared with a common non-polar commercial oil. The lipids are consumed spread on a white wheat bread. A white wheat bread without added lipids is included as a control product. The test products are consumed at breakfast, and test variables are investigated in the postprandial period after the test breakfast and also after a second meal standard lunch.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Blood glucose concentration (glucose tolerance)

  Test products will be consumed at breakfast. Blood glucose will be determined repeatedly after the breakfast and also following a standardised lunch. The primary outcome measures for glucose concentrations are incremental areas under the curve after the test breakfast and after the standardised lunch

  5.5 hours. Fasting (time =0), 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes, 210 minutes, 225 minutes, 240 minutes, 255 minutes, 270 minutes, 300 minutes, and 330 minutes.

Secondary Outcomes (4)

• Serum insulin concentrations

  5.5 hours. Fasting (time =0), 30 minutes, 45 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes, 210 minutes, 240 minutes, 255 minutes, 270 minutes, 300 minutes, and 330 minutes.

• Subjective hunger sensations

  5.5 hours. Fasting (time =0), 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes, 210 minutes, 225 minutes, 240 minutes, 255 minutes, 270 minutes, 300 minutes, and 330 minutes.

• Subjective satiety sensations

  5.5 hours. Fasting (time =0), 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes, 210 minutes, 225 minutes, 240 minutes, 255 minutes, 270 minutes, 300 minutes, and 330 minutes.

• Subjective sensations of desire to eat

  5.5 hours. Fasting (time =0), 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes, 210 minutes, 225 minutes, 240 minutes, 255 minutes, 270 minutes, 300 minutes, and 330 minutes.

Study Arms (4)

Polar lipid 1

EXPERIMENTAL

15 g Plant polar lip 1 consumed with a white wheat bread including 50 g available carbohydrates

Dietary Supplement: Polar lipid 1

Polar lipid 2

EXPERIMENTAL

15 g Plant polar lipids 2 consumed with a white wheat bread including 50 g available carbohydrates

Dietary Supplement: Polar lipid 2

non-polar lipids

ACTIVE COMPARATOR

15 g commonly consumed non-polar lipids consumed with a white wheat bread including 50 g available carbohydrates

Dietary Supplement: Non-polar lipids

no lipids

PLACEBO COMPARATOR

A white wheat bread including 50 g available carbohydrates

Other: No lipids

Interventions

Polar lipid 1 DIETARY_SUPPLEMENT

15g plant polar lipids from plant source 1. The lipid supplement is consumed spread on a commercial white wheat flour bread as a source of available carbohydrates (50 g).

Polar lipid 1

Polar lipid 2 DIETARY_SUPPLEMENT

15g plant polar lipids from plant source 2. The lipid supplement is consumed spread on a commercial white wheat flour bread as a source of available carbohydrates (50 g).

Polar lipid 2

Non-polar lipids DIETARY_SUPPLEMENT

15g non-polar plant lipids from plant source 1. The lipids supplement is consumed spread on a commercial white wheat flour bread as a source of available carbohydrates (50 g).

non-polar lipids

No lipids OTHER

A commercial white wheat flour bread as a source of available carbohydrates (50 g), without added lipids.

no lipids

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Apparently healthy men and women
• non-smokers
• between 20-40 years of age
• BMI between 18,5-30 kg/m2
• No known metabolic disorders or food allergies.
• The test subjects should follow a normal diet in accordance with the Nordic Nutrition Recommendations.

You may not qualify if:

• Fasting blood glucose ≥6.1 mmol/L
• Use of antibiotics or probiotics in the last three months or during the study period.
• Smoking
• Blood donation during the last two months and during the study.
• Food allergies or food intolerances
• Cardiovascular diseases
• Metabolic diseases
• Inflammatory bowel diseases.

Sponsors & Collaborators

• Anne Nilsson: lead

Study Sites (1)

Lund University, dep of Food Technology, Engineering, and Nutrition

Lund, Välj..., 22100, Sweden

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Due to the character of the test products, the masking is partial
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: November 20, 2023
• First Posted: November 28, 2023
• Study Start: December 6, 2023
• Primary Completion: January 25, 2024
• Study Completion: January 25, 2024
• Last Updated: January 26, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)