Fatty Acid Biomarkers of Carbohydrate Intake

Dyslipidemias Clinical Trial

— CARBIO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03295448
• Other study ID #: CARBIO
• Status: Completed
• Phase: N/A
• Start date: October 25, 2017
• Est. completion date: June 1, 2018

Study information

• Verified date: November 2018
• Source: Uppsala University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: June 1, 2018
• Est. primary completion date: June 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Dyslipidemias

Intervention

Other:
• Low carbohydrate diet
Diet low in carbohydrates (38%E), but higher in total and saturated fat.
• High carbohydrate, high sugar diet
Diet high in carbohydrates (53%E) and sugars, but low in wholegrain, rye and wheat fibre.
• High carbohydrate, low sugar diet
Diet high in carbohydrates (53%E), wholegrain, rye and wheat fibre, but low in sugars.

Locations

Country	Name	City	State
Sweden	Uppsala univeristy hospital	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
Uppsala University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Desaturation indices end lipogenic indices	These indices are product-to-precursor fatty acids measured by GC	14-20 days
Primary	Palmitic acid in different plasma fractions	Measured by liquid gas chromatography (GC)	14-20 days
Secondary	Even-chain saturated fatty acids (i.e. 14:0, 18:0) and monounsaturated fatty acids	Measured by liquid GC	14-20 days