Effects of Plant Based Lipids on Glucose Regulation and Cognitive Variables

NCT ID: NCT05276128

Last Updated: 2022-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-20

Study Completion Date

2022-04-27

Brief Summary

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The overall goal is to increase the knowledge that can be used for the development of food products with anti-diabetic properties, with the purpose to facilitate healthier food choices for people. More specifically the primary purpose of this project is to evaluate effects in healthy humans on acute postprandial glucose regulation of plant based lipids. Due to the tight connection between cardiometabolic health and cognitive functions, a secondary issue is to investigate effects of test foods on cognitive test variables and mood parameters.

Detailed Description

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Conditions

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Diabete Type 2 Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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WWB Reference

White wheat bread (WWB) without lipid supplements. The effects of this high glycaemic product on postprandial glucose and insulin responses are well studied.

Group Type OTHER

lipids

Intervention Type DIETARY_SUPPLEMENT

Investigations of dose-response effects of 3 different doses of an bioactive plant based lipid consumed at breakfast, after overnight fasting. Total amounts of lipids in each test portion are 15g, and the lower doses are supplemented with a control lipid to sum upp to 15 g total lipids. A control product with15g control lipids and without active lipids is also included. The lipids are supplemented to a white wheat bread, corresponding to 50 g available starch. A White wheat bread portion without lipid supplementation is included as a well studied reference product.

WWB 5g active lipids

WWB supplemented with 5 g active lipids, and 10 g control lipids

Group Type EXPERIMENTAL

lipids

Intervention Type DIETARY_SUPPLEMENT

Investigations of dose-response effects of 3 different doses of an bioactive plant based lipid consumed at breakfast, after overnight fasting. Total amounts of lipids in each test portion are 15g, and the lower doses are supplemented with a control lipid to sum upp to 15 g total lipids. A control product with15g control lipids and without active lipids is also included. The lipids are supplemented to a white wheat bread, corresponding to 50 g available starch. A White wheat bread portion without lipid supplementation is included as a well studied reference product.

WWB 10g active lipids

WWB supplemented with 10g active lipids, and 5 g control lipids

Group Type EXPERIMENTAL

lipids

Intervention Type DIETARY_SUPPLEMENT

Investigations of dose-response effects of 3 different doses of an bioactive plant based lipid consumed at breakfast, after overnight fasting. Total amounts of lipids in each test portion are 15g, and the lower doses are supplemented with a control lipid to sum upp to 15 g total lipids. A control product with15g control lipids and without active lipids is also included. The lipids are supplemented to a white wheat bread, corresponding to 50 g available starch. A White wheat bread portion without lipid supplementation is included as a well studied reference product.

WWB 15g active lipids

WWB supplemented with 15g active lipids, and 0 g control lipids

Group Type EXPERIMENTAL

lipids

Intervention Type DIETARY_SUPPLEMENT

Investigations of dose-response effects of 3 different doses of an bioactive plant based lipid consumed at breakfast, after overnight fasting. Total amounts of lipids in each test portion are 15g, and the lower doses are supplemented with a control lipid to sum upp to 15 g total lipids. A control product with15g control lipids and without active lipids is also included. The lipids are supplemented to a white wheat bread, corresponding to 50 g available starch. A White wheat bread portion without lipid supplementation is included as a well studied reference product.

WWB 15 g control lipids

WWB supplemented with 15g control lipids

Group Type ACTIVE_COMPARATOR

lipids

Intervention Type DIETARY_SUPPLEMENT

Investigations of dose-response effects of 3 different doses of an bioactive plant based lipid consumed at breakfast, after overnight fasting. Total amounts of lipids in each test portion are 15g, and the lower doses are supplemented with a control lipid to sum upp to 15 g total lipids. A control product with15g control lipids and without active lipids is also included. The lipids are supplemented to a white wheat bread, corresponding to 50 g available starch. A White wheat bread portion without lipid supplementation is included as a well studied reference product.

Interventions

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lipids

Investigations of dose-response effects of 3 different doses of an bioactive plant based lipid consumed at breakfast, after overnight fasting. Total amounts of lipids in each test portion are 15g, and the lower doses are supplemented with a control lipid to sum upp to 15 g total lipids. A control product with15g control lipids and without active lipids is also included. The lipids are supplemented to a white wheat bread, corresponding to 50 g available starch. A White wheat bread portion without lipid supplementation is included as a well studied reference product.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Apparently healthy subjects
* Between 20 and 40 years old
* Body mass index between 19-28 kg / m2),
* Consuming a non-vegetarian diet generally in line with the Nordic nutrition recommendations.

Exclusion Criteria

* Fasting blood glucose concentration \>6.1 mmol/L
* Known metabolic or gastrointestinal disorder (eg diabetes, high cholesterol, high blood pressure, IBS), or other disease that may affect the study results.
* Regular medication, except for long-term and stable medication for the lack or reduced production of thyroid hormone (eg Levaxin).
* Antibiotics or probiotics for at least four weeks before the start of the study,
* The use of tobacco products
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Lund University

OTHER

Sponsor Role lead

Responsible Party

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Anne Nilsson

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Anne Nilsson

Lund, Välj..., Sweden

Site Status

The Human Trial Facility, Food Technology engineering and Nutrition, Lund University

Lund, Välj..., Sweden

Site Status

Countries

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Sweden

Other Identifiers

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2018/658

Identifier Type: -

Identifier Source: org_study_id

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