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CompletedNCT03295448CARBIOUpdated Nov 15, 2018

Fatty Acid Biomarkers of Carbohydrate Intake

An interventional study of Low carbohydrate diet and High carbohydrate, high sugar diet in Dyslipidemias, sponsored by Uppsala University. Completed at 1 site in Sweden. Open to participants aged 20 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-11-15.

Sponsored by Uppsala University · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
19
Allocation
Randomized
Ages
20 Years to 75 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Dyslipidemias

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Keywords

  • fatty acids
  • biomarker
  • carbohydrate
  • lipogenesis
03

Who can participate

Ages eligible
20 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • BMI 20-38

Exclusion criteria

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
04

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
19 participants (actual)

Study arms

  • 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 · Other: High carbohydrate, high sugar diet · Other: High carbohydrate, low sugar diet

  • 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 · Other: High carbohydrate, high sugar diet · Other: High carbohydrate, low sugar diet

  • 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 · Other: High carbohydrate, high sugar diet · Other: High carbohydrate, low sugar diet

  • 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 · Other: High carbohydrate, high sugar diet · Other: High carbohydrate, low sugar diet

  • 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 · Other: High carbohydrate, high sugar diet · Other: High carbohydrate, low sugar diet

  • 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 · Other: High carbohydrate, high sugar diet · Other: High carbohydrate, low sugar diet

Interventions

  • OtherLow carbohydrate diet

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

  • OtherHigh carbohydrate, high sugar diet

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

  • OtherHigh carbohydrate, low sugar diet

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

05

What researchers measure

Primary outcomes

  1. Palmitic acid in different plasma fractions

    Measured by liquid gas chromatography (GC)

    Time frame: 14-20 days

Secondary outcomes

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

    Measured by liquid GC

    Time frame: 14-20 days

Other outcomes

  1. Desaturation indices end lipogenic indices

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

    Time frame: 14-20 days

06

Study locations

1 site
  • Uppsala univeristy hospital
    Uppsala, 75185, Sweden
07

Registry details

Key details

Study ID
NCT03295448
Lead sponsor
Uppsala University
Responsible party
Sponsor
First posted
Sep 27, 2017
Start date
Oct 25, 2017
Primary completion
Jun 1, 2018
Completion
Jun 1, 2018
Last update
Nov 15, 2018

Study contacts

Ulf Riserus, PhD
principal investigator · Uppsala University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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