HealthySEMNCT02647970
Stearoyl-CoA Desaturase and Energy Metabolism in Humans
A study testing PUFA-Cys/Met diet and SFA+Cys/Met diet in people with Healthy and Obesity, run by University of Oslo at 1 site in Norway.
Trial summary
The aim of this study is to examine if changing stearoyl-coenzyme A desaturase-1 (SCD1) activity through dietary interventions can increase energy metabolism in humans. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- What is being tested?
- PUFA-Cys/Met diet and SFA+Cys/Met diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteNorway
- Study dates
- Feb 2016to Nov 2016
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy normal-weight (BMI 20-25 kg/m2)
Who cannot join
- High physical activity
- Smoking
- High intake of fatty fish or cod liver oil
- Drugs
- Pregnancy or breastfeeding
- Chronic disease
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to examine if changing stearoyl-coenzyme A desaturase-1 (SCD1) activity through dietary interventions can increase energy metabolism in humans.
Read the detailed description
In rodents as well as humans, high stearoyl-coenzyme A desaturase-1 (SCD1) activity is considered to be involved in development of obesity. In animal models, polyunsaturated fatty acids (PUFA) inhibit Scd1 gene expression and at the population level, dietary PUFA and plasma PUFA show strong inverse associations with plasma SCD indices. Emerging evidence also suggests a role for the sulphur amino acid cysteine in regulating SCD1 activity and obesity.
The overall aim of the project is to examine if interventions that lowers SCD1 activity lead to increased energy metabolism. In this project, the investigators will conduct dietary intervention trials to evaluate the effects of short-term consumption of a diet rich in polyunsaturated fatty acids (PUFA) and low in cysteine and its precursor methionine (PUFA-Cys/Met) vs. a diet rich in saturated fatty acids (SFA) and cysteine/methionine (SFA+Cys/Met) on SCD1 activity, lipids, amino acids, glucose and other biomarkers related to energy metabolism, in healthy normal-weight subjects. Healthy volunteers will be randomized to the PUFA-Cys/Met or SFA+Cys/Met diets receiving supplements/meals in a single dose or for 7 days.
This study is a pilot study, with main focus on feasibility, tolerance and side effects. If the pilot shows positive results in terms of side effects, safety and tolerance, the investigators will follow-up by including obese subjects in a longer dietary intervention.
- Being tested
- PUFA-Cys/Met diet, SFA+Cys/Met diet
- Keywords
- Energy metabolism
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PUFA-Cys/Met dietBehavioural
Provision of food and supplements that are rich in polyunsaturated fatty acids (PUFA, n-3 and n-6) and low in the amino acids cysteine (Cys) and methionine (Met).
SFA+Cys/Met dietBehavioural
Provision of food and supplements that are rich in saturated fatty acids (SFA) and the amino acids cysteine (Cys) and methionine (Met).
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Dietary intervention Receives: Behavioral: PUFA-Cys/Met diet |
| Group B | Active comparator | Dietary intervention Receives: Behavioral: SFA+Cys/Met diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in metabolic biomarkers
Measurement of biomarkers of amino acid and fatty acid metabolism, including plasma concentration of cysteine, methionine, fatty acids, and stearoyl CoA desaturase (SCD) indices
Measured: 0 hour and at 30 min, 1, 2, 3, 4, 6, 8, 12, 24, 48 and 72 h after single meal. Baseline and up to 7 days in 7 days intervention
Secondary outcomes (8)
Change in biomarkers of glucose metabolism
Measurements of blood parameters including glucose and insulin, and Oral Glucose Tolerance Test
Measured: Baseline and up to 7 days
Change in biomarkers of triglycerides metabolism
Measurements of blood parameters including LDL-/HDL-/VLDL-/total cholesterol, and triglycerides
Measured: Baseline and up to 7 days
Change in molecular signatures
Evaluation of markers related to lipid, amino acid and glucose metabolism, including measurements of mRNA expression in blood cells, and proteins and metabolites, in blood and/or urine
Measured: Baseline and up to 7 days
Hunger and satiety patterns
Evaluated by plasma levels of hormones such as leptin, ghrelin, cholecystokinin, GLP-1 and PYY
Measured: Baseline and up to 7 days
Appetite assessed by visual analogue scales
Measured: 0, 15, 30, 45, 60, 90, 120, 180 minutes postprandially (single meal intervention). Change from baseline up to 7 days (7 days intervention)
Change in inflammatory markers
Measurements of blood parameters, e.g., CRP, cytokines and chemokines, adipokines, metabolic markers, hormones, growth factors, tissue remodeling proteins, angiogenesis markers, acute phase reactants, and other important circulating proteins.
Measured: Baseline and up to 7 days
Feasibility and compliance of the diet intervention
Evaluated by compliance questionnaires
Measured: Up to 7 days
Tolerance of the diet intervention
Assessed by blood pressure, pulse and laboratory parameters including haematology, clinical chemistry and urine analysis
Measured: Up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2016 (estimated)
- Study startFeb 2016
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oslo
- Sponsor type
- University, hospital or other
- Collaborators
- The Research Council of Norway, University of Oxford
- Responsible party
- Principal investigator, Kathrine Vinknes, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02647970
- Sponsor's protocol ID
- 239948-A
- Other IDs
- 2015/634
- Acronym
- SEM
- Status last verified
- Sep 2018
- First submitted
- 4 Dec 2015
- Last updated
- 18 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Elshorbagy A, Bastani NE, Lee-Odegard S, Ovrebo B, Haj-Yasein N, Svendsen K, Turner C, Refsum H, Vinknes KJ, Olsen T. The association of fasting plasma thiol fractions with body fat compartments, biomarker profile, and adipose tissue gene expression. Amino Acids. 2023 Mar;55(3):313-323. doi: 10.1007/s00726-022-03229-2. Epub 2022 Dec 21.
PubMed 36542145Olsen T, Ovrebo B, Turner C, Bastani NE, Refsum H, Vinknes KJ. Effects of short-term methionine and cysteine restriction and enrichment with polyunsaturated fatty acids on oral glucose tolerance, plasma amino acids, fatty acids, lactate and pyruvate: results from a pilot study. BMC Res Notes. 2021 Feb 2;14(1):43. doi: 10.1186/s13104-021-05463-5.
PubMed 33531059Olsen T, Turner C, Ovrebo B, Bastani NE, Refsum H, Vinknes KJ. Postprandial effects of a meal low in sulfur amino acids and high in polyunsaturated fatty acids compared to a meal high in sulfur amino acids and saturated fatty acids on stearoyl CoA-desaturase indices and plasma sulfur amino acids: a pilot study. BMC Res Notes. 2020 Aug 10;13(1):379. doi: 10.1186/s13104-020-05222-y.
PubMed 32778150
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stearoyl-CoA Desaturase and Energy Metabolism in Humans
- ClinicalTrials.gov ID
- NCT02647970
- Acronym / sponsor ID
- SEM / 239948-A
- Keywords
- Energy metabolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of OsloUniversity, hospital or other
- Collaborators
- The Research Council of Norway, University of Oxford
- Study start
- Feb 2016
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 6 Jan 2016 (estimated)
- 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 aim of this study is to examine if changing stearoyl-coenzyme A desaturase-1 (SCD1) activity through dietary interventions can increase energy metabolism in humans.
Detailed description
In rodents as well as humans, high stearoyl-coenzyme A desaturase-1 (SCD1) activity is considered to be involved in development of obesity. In animal models, polyunsaturated fatty acids (PUFA) inhibit Scd1 gene expression and at the population level, dietary PUFA and plasma PUFA show strong inverse associations with plasma SCD indices. Emerging evidence also suggests a role for the sulphur amino acid cysteine in regulating SCD1 activity and obesity.
The overall aim of the project is to examine if interventions that lowers SCD1 activity lead to increased energy metabolism. In this project, the investigators will conduct dietary intervention trials to evaluate the effects of short-term consumption of a diet rich in polyunsaturated fatty acids (PUFA) and low in cysteine and its precursor methionine (PUFA-Cys/Met) vs. a diet rich in saturated fatty acids (SFA) and cysteine/methionine (SFA+Cys/Met) on SCD1 activity, lipids, amino acids, glucose and other biomarkers related to energy metabolism, in healthy normal-weight subjects. Healthy volunteers will be randomized to the PUFA-Cys/Met or SFA+Cys/Met diets receiving supplements/meals in a single dose or for 7 days.
This study is a pilot study, with main focus on feasibility, tolerance and side effects. If the pilot shows positive results in terms of side effects, safety and tolerance, the investigators will follow-up by including obese subjects in a longer dietary intervention.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Behavioral: PUFA-Cys/Met dietDietary intervention |
| Group B | Active comparator | Behavioral: SFA+Cys/Met dietDietary intervention |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy normal-weight (BMI 20-25 kg/m2)
Key exclusion criteria (6 listed)
- High physical activity
- Smoking
- High intake of fatty fish or cod liver oil
- Drugs
- Pregnancy or breastfeeding
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 |
|---|---|---|
| PUFA-Cys/Met dietProvision of food and supplements that are rich in polyunsaturated fatty acids (PUFA, n-3 and n-6) and low in the amino acids cysteine (Cys) and methionine (Met). | Behavioural | Group A |
| SFA+Cys/Met dietProvision of food and supplements that are rich in saturated fatty acids (SFA) and the amino acids cysteine (Cys) and methionine (Met). | Behavioural | Group B |
Primary outcome
Change in metabolic biomarkers
Time frame: 0 hour and at 30 min, 1, 2, 3, 4, 6, 8, 12, 24, 48 and 72 h after single meal. Baseline and up to 7 days in 7 days intervention
Measurement of biomarkers of amino acid and fatty acid metabolism, including plasma concentration of cysteine, methionine, fatty acids, and stearoyl CoA desaturase (SCD) indices
8 secondary outcomes
Change in biomarkers of glucose metabolism
Time frame: Baseline and up to 7 days
Change in biomarkers of triglycerides metabolism
Time frame: Baseline and up to 7 days
Change in molecular signatures
Time frame: Baseline and up to 7 days
Hunger and satiety patterns
Time frame: Baseline and up to 7 days
Appetite assessed by visual analogue scales
Time frame: 0, 15, 30, 45, 60, 90, 120, 180 minutes postprandially (single meal intervention). Change from baseline up to 7 days (7 days intervention)
Change in inflammatory markers
Time frame: Baseline and up to 7 days
Feasibility and compliance of the diet intervention
Time frame: Up to 7 days
Tolerance of the diet intervention
Time frame: Up to 7 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 18 Sep 2018.
- Derived from this study: PubMed 36542145Elshorbagy A, Bastani NE, Lee-Odegard S, Ovrebo B, Haj-Yasein N, Svendsen K, Turner C, Refsum H, Vinknes KJ, Olsen T. The association of fasting plasma thiol fractions with body fat compartments, biomarker profile, and adipose tissue gene expression. Amino Acids. 2023 Mar;55(3):313-323. doi: 10.1007/s00726-022-03229-2. Epub 2022 Dec 21.
- Derived from this study: PubMed 33531059Olsen T, Ovrebo B, Turner C, Bastani NE, Refsum H, Vinknes KJ. Effects of short-term methionine and cysteine restriction and enrichment with polyunsaturated fatty acids on oral glucose tolerance, plasma amino acids, fatty acids, lactate and pyruvate: results from a pilot study. BMC Res Notes. 2021 Feb 2;14(1):43. doi: 10.1186/s13104-021-05463-5.
- Derived from this study: PubMed 32778150Olsen T, Turner C, Ovrebo B, Bastani NE, Refsum H, Vinknes KJ. Postprandial effects of a meal low in sulfur amino acids and high in polyunsaturated fatty acids compared to a meal high in sulfur amino acids and saturated fatty acids on stearoyl CoA-desaturase indices and plasma sulfur amino acids: a pilot study. BMC Res Notes. 2020 Aug 10;13(1):379. doi: 10.1186/s13104-020-05222-y.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PUFA-Cys/Met diet and SFA+Cys/Met diet in people with Healthy and Obesity, run by University of Oslo at 1 site in Norway.
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 6 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 18 Sep 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 Norway. 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?
Change in metabolic biomarkers (time frame: 0 hour and at 30 min, 1, 2, 3, 4, 6, 8, 12, 24, 48 and 72 h after single meal. Baseline and up to 7 days in 7 days intervention). 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 NCT02647970, which also lists 3 linked publications.
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 18 Sep 2018.