DyslipidemiasCARBIONCT03295448
Fatty Acid Biomarkers of Carbohydrate Intake
A study testing Low carbohydrate diet, High carbohydrate, high sugar diet and High carbohydrate, low sugar diet in people with Dyslipidemias, run by Uppsala University at 1 site in Sweden.
Trial summary
The overall aim is to investigate if circulating fatty acids and lipids are influenced by alterations in carbohydrate amount and quality. Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Dyslipidemias
- What is being tested?
- Low carbohydrate diet, High carbohydrate, high sugar diet and High carbohydrate, low sugar diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteSweden
- Study dates
- 25 Oct 2017to 1 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI 20-38
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Conditions
- Dyslipidemias
- Being tested
- Low carbohydrate diet, High carbohydrate, high sugar diet, High carbohydrate, low sugar diet
- Keywords
- fatty acids, biomarker, carbohydrate, lipogenesis
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low carbohydrate dietOther
Diet low in carbohydrates (38%E), but higher in total and saturated fat.
High carbohydrate, high sugar dietOther
Diet high in carbohydrates (53%E) and sugars, but low in wholegrain, rye and wheat fibre.
High carbohydrate, low sugar dietOther
Diet high in carbohydrates (53%E), wholegrain, rye and wheat fibre, but low in sugars.
| Study group | Role | What they receive |
|---|---|---|
| Fat - Sugar - Fiber | Active comparator | 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. Receives: Other: Low carbohydrate diet; Other: High carbohydrate, high sugar diet; Other: High carbohydrate, low sugar diet |
| Fat - Fiber - Sugar | Active comparator | 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. Receives: Other: Low carbohydrate diet; Other: High carbohydrate, high sugar diet; Other: High carbohydrate, low sugar diet |
| Sugar - Fiber - Fat | Active comparator | 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. Receives: Other: Low carbohydrate diet; Other: High carbohydrate, high sugar diet; Other: High carbohydrate, low sugar diet |
| Sugar - Fat - Fiber | Active comparator | 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. Receives: Other: Low carbohydrate diet; Other: High carbohydrate, high sugar diet; Other: High carbohydrate, low sugar diet |
| Fiber - Sugar - Fat | Active comparator | 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. Receives: Other: Low carbohydrate diet; Other: High carbohydrate, high sugar diet; Other: High carbohydrate, low sugar diet |
| Fiber - Fat - Sugar | Active comparator | 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. Receives: Other: Low carbohydrate diet; Other: High carbohydrate, high sugar diet; Other: High carbohydrate, low sugar diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Palmitic acid in different plasma fractions
Measured by liquid gas chromatography (GC)
Measured: 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
Measured: 14-20 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2017
- Study start25 Oct 2017
- Primary completion1 Jun 2018
- Study completion1 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DyslipidemiasStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ulf Riserus, PhD, Principal investigator, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03295448
- Sponsor's protocol ID
- CARBIO
- Acronym
- CARBIO
- Status last verified
- Nov 2018
- First submitted
- 22 Sep 2017
- Last updated
- 15 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bajahzer MF, Rosqvist F, Friden M, Iggman D, Pingel R, Marklund M, Riserus U. Contrasting Carbohydrate Quantity and Quality and the Effects on Plasma Saturated and Monounsaturated Fatty Acids in Healthy Adults: A Randomized Controlled Trial. J Nutr. 2023 Mar;153(3):683-690. doi: 10.1016/j.tjnut.2023.01.005. Epub 2023 Jan 13.
PubMed 36797136
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circulating Fatty Acids as Biomarkers of Dietary Carbohydrates: a Randomized Trial
- ClinicalTrials.gov ID
- NCT03295448
- Acronym / sponsor ID
- CARBIO / CARBIO
- Conditions
- Dyslipidemias
- Keywords
- fatty acids, biomarker, carbohydrate, lipogenesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Study start
- 25 Oct 2017 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 1 Jun 2018 (actual)
- First posted
- 27 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Fat - Sugar - Fiber | Active comparator | Other: Low carbohydrate diet, Other: High carbohydrate, high sugar diet, Other: High carbohydrate, low sugar dietIntervention: 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. |
| Fat - Fiber - Sugar | Active comparator | Other: Low carbohydrate diet, Other: High carbohydrate, high sugar diet, Other: High carbohydrate, low sugar dietIntervention: 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. |
| Sugar - Fiber - Fat | Active comparator | Other: Low carbohydrate diet, Other: High carbohydrate, high sugar diet, Other: High carbohydrate, low sugar dietIntervention: 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. |
| Sugar - Fat - Fiber | Active comparator | Other: Low carbohydrate diet, Other: High carbohydrate, high sugar diet, Other: High carbohydrate, low sugar dietIntervention: 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. |
| Fiber - Sugar - Fat | Active comparator | Other: Low carbohydrate diet, Other: High carbohydrate, high sugar diet, Other: High carbohydrate, low sugar dietIntervention: 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. |
| Fiber - Fat - Sugar | Active comparator | Other: Low carbohydrate diet, Other: High carbohydrate, high sugar diet, Other: High carbohydrate, low sugar dietIntervention: 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. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- BMI 20-38
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low carbohydrate dietDiet low in carbohydrates (38%E), but higher in total and saturated fat. | Other | Fat - Fiber - Sugar, Fat - Sugar - Fiber, Fiber - Fat - Sugar, Fiber - Sugar - Fat, Sugar - Fat - Fiber, Sugar - Fiber - Fat |
| High carbohydrate, high sugar dietDiet high in carbohydrates (53%E) and sugars, but low in wholegrain, rye and wheat fibre. | Other | Fat - Fiber - Sugar, Fat - Sugar - Fiber, Fiber - Fat - Sugar, Fiber - Sugar - Fat, Sugar - Fat - Fiber, Sugar - Fiber - Fat |
| High carbohydrate, low sugar dietDiet high in carbohydrates (53%E), wholegrain, rye and wheat fibre, but low in sugars. | Other | Fat - Fiber - Sugar, Fat - Sugar - Fiber, Fiber - Fat - Sugar, Fiber - Sugar - Fat, Sugar - Fat - Fiber, Sugar - Fiber - Fat |
Primary outcome
Palmitic acid in different plasma fractions
Time frame: 14-20 days
Measured by liquid gas chromatography (GC)
1 secondary outcome
Even-chain saturated fatty acids (i.e. 14:0, 18:0) and monounsaturated fatty acids
Time frame: 14-20 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2018.
- Derived from this study: PubMed 36797136Bajahzer MF, Rosqvist F, Friden M, Iggman D, Pingel R, Marklund M, Riserus U. Contrasting Carbohydrate Quantity and Quality and the Effects on Plasma Saturated and Monounsaturated Fatty Acids in Healthy Adults: A Randomized Controlled Trial. J Nutr. 2023 Mar;153(3):683-690. doi: 10.1016/j.tjnut.2023.01.005. Epub 2023 Jan 13.
Related trials for Dyslipidemias
Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Not yet recruiting
Plasma Lipids-Dependent Vitamin E Metabolism During Dynamic Hyperlipidemia
Lipid Metabolism Disorders
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
Active, not recruiting
Developing a Learning COmmunity to Increase eNgagemeNt and Enrollment in Cardiovascular Clinical Trials (CONNECT)
Cardiovascular Diseases, Hypertension
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ulf Riserus, PhD principal investigator
Uppsala University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low carbohydrate diet, High carbohydrate, high sugar diet and High carbohydrate, low sugar diet in people with Dyslipidemias, run by Uppsala University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Palmitic acid in different plasma fractions (time frame: 14-20 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03295448, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2018.