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Fatty Acid Biomarkers of Carbohydrate Intake (CARBIO)

Primary Purpose

Dyslipidemias

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Low carbohydrate diet
High carbohydrate, high sugar diet
High carbohydrate, low sugar diet
Sponsored by
Uppsala University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Dyslipidemias focused on measuring fatty acids, biomarker, carbohydrate, lipogenesis

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Uppsala univeristy hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Fat - Sugar - Fiber

Fat - Fiber - Sugar

Sugar - Fiber - Fat

Sugar - Fat - Fiber

Fiber - Sugar - Fat

Fiber - Fat - Sugar

Arm Description

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.

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.

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Palmitic acid in different plasma fractions
Measured by liquid gas chromatography (GC)

Secondary Outcome Measures

Even-chain saturated fatty acids (i.e. 14:0, 18:0) and monounsaturated fatty acids
Measured by liquid GC

Full Information

First Posted
September 22, 2017
Last Updated
November 14, 2018
Sponsor
Uppsala University
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1. Study Identification

Unique Protocol Identification Number
NCT03295448
Brief Title
Fatty Acid Biomarkers of Carbohydrate Intake
Acronym
CARBIO
Official Title
Circulating Fatty Acids as Biomarkers of Dietary Carbohydrates: a Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
October 25, 2017 (Actual)
Primary Completion Date
June 1, 2018 (Actual)
Study Completion Date
June 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Uppsala University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslipidemias
Keywords
fatty acids, biomarker, carbohydrate, lipogenesis

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fat - Sugar - Fiber
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Fat - Fiber - Sugar
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Sugar - Fiber - Fat
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Sugar - Fat - Fiber
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Fiber - Sugar - Fat
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Fiber - Fat - Sugar
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Low carbohydrate diet
Intervention Description
Diet low in carbohydrates (38%E), but higher in total and saturated fat.
Intervention Type
Other
Intervention Name(s)
High carbohydrate, high sugar diet
Intervention Description
Diet high in carbohydrates (53%E) and sugars, but low in wholegrain, rye and wheat fibre.
Intervention Type
Other
Intervention Name(s)
High carbohydrate, low sugar diet
Intervention Description
Diet high in carbohydrates (53%E), wholegrain, rye and wheat fibre, but low in sugars.
Primary Outcome Measure Information:
Title
Palmitic acid in different plasma fractions
Description
Measured by liquid gas chromatography (GC)
Time Frame
14-20 days
Secondary Outcome Measure Information:
Title
Even-chain saturated fatty acids (i.e. 14:0, 18:0) and monounsaturated fatty acids
Description
Measured by liquid GC
Time Frame
14-20 days
Other Pre-specified Outcome Measures:
Title
Desaturation indices end lipogenic indices
Description
These indices are product-to-precursor fatty acids measured by GC
Time Frame
14-20 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ulf Riserus, PhD
Organizational Affiliation
Uppsala University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Uppsala univeristy hospital
City
Uppsala
ZIP/Postal Code
75185
Country
Sweden

12. IPD Sharing Statement

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Fatty Acid Biomarkers of Carbohydrate Intake

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