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Completed

NCT Number: NCT03295448

Fatty Acid Biomarkers of Carbohydrate Intake

The overall aim is to investigate if circulating fatty acids and lipids are influenced by alterations in carbohydrate amount and quality.

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Key information

Conditions

Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Uppsala univeristy hospital

Uppsala, 75185, Sweden

About this study

In this isocaloric clinical cross-over trial, the investigators aim to investigate if circulating fatty acids and lipids are influenced by alterations in carbohydrate amount and quality. The investigators intend to evaluate if changes in carbohydrate quantity and quality (including sugar) influence circulating even-chain saturated fatty acids or if fatty acid-derived indices of desaturation and de novo lipogenesis are more sensitive biomarkers of carbohydrate intake. By performing untargeted lipidomic analyses, the investigators aim to search for novel lipid biomarkers of carbohydrate quantity and quality. The investigators also want to evaluate the influence of moderate alterations of carbohydrate and sugar intake on lipoproteins, insulin sensitivity, inflammatory proteins.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • BMI 20-38

Exclusion criteria

  • abnormal lab tests (assessed by screening and judged by a physician), diabetes, cardiovascular, kidney, liver or malignant disease, and weight-loss (±3kg) the preceding 3 months of screening. Extreme diets, i.e. very-low carbohydrate diets, intermittent fasting, vegan diets or allergic to gluten

Treatment and study plan

Low carbohydrate diet

Other

Diet low in carbohydrates (38%E), but higher in total and saturated fat.

High carbohydrate, high sugar diet

Other

Diet high in carbohydrates (53%E) and sugars, but low in wholegrain, rye and wheat fibre.

High carbohydrate, low sugar diet

Other

Diet high in carbohydrates (53%E), wholegrain, rye and wheat fibre, but low in sugars.

Primary outcomes

  1. Palmitic acid in different plasma fractions

    Time frame: 14-20 days

    Measured by liquid gas chromatography (GC)

Secondary outcomes

  1. Even-chain saturated fatty acids (i.e. 14:0, 18:0) and monounsaturated fatty acids

    Time frame: 14-20 days

    Measured by liquid GC

Other outcomes

  1. Desaturation indices end lipogenic indices

    Time frame: 14-20 days

    These indices are product-to-precursor fatty acids measured by GC

Sponsors and collaborators

Lead sponsor

Uppsala University

Other

Registry information

Official study title

Circulating Fatty Acids as Biomarkers of Dietary Carbohydrates: a Randomized Trial

Acronym: CARBIO

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Sep 27, 2017
Registry last updated
Nov 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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