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Fatty Acid Biomarkers of Carbohydrate Intake (CARBIO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03295448
Recruitment Status : Completed
First Posted : September 27, 2017
Last Update Posted : November 15, 2018
Sponsor:
Information provided by (Responsible Party):
Uppsala University

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

Condition or disease Intervention/treatment Phase
Dyslipidemias Other: Low carbohydrate diet Other: High carbohydrate, high sugar diet Other: High carbohydrate, low sugar diet Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Circulating Fatty Acids as Biomarkers of Dietary Carbohydrates: a Randomized Trial
Actual Study Start Date : October 25, 2017
Actual Primary Completion Date : June 1, 2018
Actual Study Completion Date : June 1, 2018

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.




Primary Outcome Measures :
  1. Palmitic acid in different plasma fractions [ Time Frame: 14-20 days ]
    Measured by liquid gas chromatography (GC)


Secondary Outcome Measures :
  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 Outcome Measures:
  1. Desaturation indices end lipogenic indices [ Time Frame: 14-20 days ]
    These indices are product-to-precursor fatty acids measured by GC



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03295448


Locations
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Sweden
Uppsala univeristy hospital
Uppsala, Sweden, 75185
Sponsors and Collaborators
Uppsala University
Investigators
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Principal Investigator: Ulf Riserus, PhD Uppsala University
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Responsible Party: Uppsala University
ClinicalTrials.gov Identifier: NCT03295448    
Other Study ID Numbers: CARBIO
First Posted: September 27, 2017    Key Record Dates
Last Update Posted: November 15, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Uppsala University:
fatty acids
biomarker
carbohydrate
lipogenesis
Additional relevant MeSH terms:
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Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases