Fatty Acid Biomarkers of Carbohydrate Intake (CARBIO)

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

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

Study Overview

• Status: Completed
• Conditions: Dyslipidemias
• Intervention / Treatment: Other: Low carbohydrate diet; Other: High carbohydrate, high sugar diet; Other: High carbohydrate, low sugar diet

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Uppsala, Sweden, 75185
    • Uppsala Univeristy Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Fat - Sugar - Fiber; Intervention: consuming diets rich in fat, rich in sugar, and rich in fibers during treatment periods 1, 2, and 3, respectively. Treatment periods are separated by one week of habitual diet.	Other: Low carbohydrate diet; Diet low in carbohydrates (38%E), but higher in total and saturated fat.; Other: High carbohydrate, high sugar diet; Diet high in carbohydrates (53%E) and sugars, but low in wholegrain, rye and wheat fibre.; Other: High carbohydrate, low sugar diet; Diet high in carbohydrates (53%E), wholegrain, rye and wheat fibre, but low in sugars.
Active Comparator: Fat - Fiber - Sugar; Intervention: consuming diets rich in fat, rich in fiber, and rich sugar during treatment periods 1, 2, and 3, respectively. Treatment periods are separated by one week of habitual diet.	Other: Low carbohydrate diet; Diet low in carbohydrates (38%E), but higher in total and saturated fat.; Other: High carbohydrate, high sugar diet; Diet high in carbohydrates (53%E) and sugars, but low in wholegrain, rye and wheat fibre.; Other: High carbohydrate, low sugar diet; Diet high in carbohydrates (53%E), wholegrain, rye and wheat fibre, but low in sugars.
Active Comparator: Sugar - Fiber - Fat; Intervention: Consuming diets rich in sugar, rich in fiber, and rich in fat during treatment periods 1, 2, and 3, respectively. Treatment periods are separated by one week of habitual diet.	Other: Low carbohydrate diet; Diet low in carbohydrates (38%E), but higher in total and saturated fat.; Other: High carbohydrate, high sugar diet; Diet high in carbohydrates (53%E) and sugars, but low in wholegrain, rye and wheat fibre.; Other: High carbohydrate, low sugar diet; Diet high in carbohydrates (53%E), wholegrain, rye and wheat fibre, but low in sugars.
Active Comparator: Sugar - Fat - Fiber; Intervention: Consuming diets rich in sugar, rich in fat, and rich in fiber during treatment periods 1, 2, and 3, respectively. Treatment periods are separated by one week of habitual diet.	Other: Low carbohydrate diet; Diet low in carbohydrates (38%E), but higher in total and saturated fat.; Other: High carbohydrate, high sugar diet; Diet high in carbohydrates (53%E) and sugars, but low in wholegrain, rye and wheat fibre.; Other: High carbohydrate, low sugar diet; Diet high in carbohydrates (53%E), wholegrain, rye and wheat fibre, but low in sugars.
Active Comparator: Fiber - Sugar - Fat; Intervention: Consuming diets rich in fiber, rich in sugar, and rich in fat during treatment periods 1, 2, and 3, respectively. Treatment periods are separated by one week of habitual diet.	Other: Low carbohydrate diet; Diet low in carbohydrates (38%E), but higher in total and saturated fat.; Other: High carbohydrate, high sugar diet; Diet high in carbohydrates (53%E) and sugars, but low in wholegrain, rye and wheat fibre.; Other: High carbohydrate, low sugar diet; Diet high in carbohydrates (53%E), wholegrain, rye and wheat fibre, but low in sugars.
Active Comparator: Fiber - Fat - Sugar; Intervention: consuming diets rich in fiber, rich in fat, and rich in fiber during treatment periods 1, 2, and 3, respectively. Treatment periods are separated by one week of habitual diet.	Other: Low carbohydrate diet; Diet low in carbohydrates (38%E), but higher in total and saturated fat.; Other: High carbohydrate, high sugar diet; Diet high in carbohydrates (53%E) and sugars, but low in wholegrain, rye and wheat fibre.; Other: High carbohydrate, low sugar diet; Diet high in carbohydrates (53%E), wholegrain, rye and wheat fibre, but low in sugars.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Palmitic acid in different plasma fractions	Measured by liquid gas chromatography (GC)	14-20 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Even-chain saturated fatty acids (i.e. 14:0, 18:0) and monounsaturated fatty acids	Measured by liquid GC	14-20 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Desaturation indices end lipogenic indices	These indices are product-to-precursor fatty acids measured by GC	14-20 days

Collaborators and Investigators

• Sponsor: Uppsala University
• Investigators: Principal Investigator: Ulf Riserus, PhD, Uppsala University

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2017
• Primary Completion (Actual): June 1, 2018
• Study Completion (Actual): June 1, 2018

Study Registration Dates

• First Submitted: September 22, 2017
• First Submitted That Met QC Criteria: September 22, 2017
• First Posted (Actual): September 27, 2017

Study Record Updates

• Last Update Posted (Actual): November 15, 2018
• Last Update Submitted That Met QC Criteria: November 14, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: biomarker; carbohydrate; fatty acids; lipogenesis
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias
• Other Study ID Numbers: CARBIO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No