OverweightNCT03629392
Methionine and Cysteine Restriction in Humans
A study testing Low met/cys diet, Moderate met/cys diet and High met/cys diet in people with Overweight, run by University of Oslo at 1 site in Norway.
Trial summary
The aim of this study is to examine the effect of methionine and cysteine restriction on energy and macronutrient metabolism in overweight human subjects Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Overweight
- What is being tested?
- Low met/cys diet, Moderate met/cys diet and High met/cys diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteNorway
- Study dates
- 8 Oct 2018to 11 Dec 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index of 25-35 kg/m2
Who cannot join
- High physical activity
- Smoking
- Drugs
- Chronic disease
- Pregnancy or breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dietary Methionine and Cysteine Restriction in Overweight Human Subjects
The aim of this study is to examine the effect of methionine and cysteine restriction on energy and macronutrient metabolism in overweight human subjects
Read the detailed description
The sulfur-containing amino acid methionine and its downstream metabolite cysteine has been associated with fat mass in animal studies and human observational studies. Some of the proposed mechanisms include an association with lipogenesis, insulin sensitivity and disrupted energy metabolism.
The overall aim of this project is to evaluate the effects of a diet low in methionine and cysteine on markers of lipids, amino acids, glucose and other biomarkers related to energy metabolism, including transcriptomic and protein expression data from adipose tissue and lymphocytes. Overweight and obese but otherwise healthy volunteers will be randomized to receive a diet either low, moderate or high in methionine and cysteine concentrations for 1 week.
This is a pilot study that may be considered an extension of NCT02647970. In addition to the primary and secondary outcomes we will evaluate the feasibility of the intervention and procedures.
- Conditions
- Overweight
- Being tested
- Low met/cys diet, Moderate met/cys diet, High met/cys diet
- Keywords
- Methionine, Cysteine, Energy metabolism, Sulfur amino acids
- Medical subject headings
- Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low met/cys dietBehavioural
Dietary intervention with low contents of methionine and cysteine
Moderate met/cys dietBehavioural
Dietary intervention with moderate contents of methionine and cysteine
High met/cys dietBehavioural
Dietary intervention with high contents of methionine and cysteine
| Study group | Role | What they receive |
|---|---|---|
| Low met/cys diet | Experimental | Dietary intervention Receives: Behavioral: Low met/cys diet |
| Moderate met/cys diet | Experimental | Dietary intervention Receives: Behavioral: Moderate met/cys diet |
| High met/cys diet | Active comparator | Dietary intervention Receives: Behavioral: High met/cys diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in plasma concentrations of amino acids
Measurement of biomarkers of amino acid metabolism, including plasma concentrations of methionine, cysteine and related metabolites
Measured: Baseline, Day 1, Day 3 and Day 7 (final visit)
Change in protein expression activity in tissues
Measurement of protein expression and activity related to methionine and cysteine metabolism in adipose tissue and lymphocytes.
Measured: Baseline and day 7 (final visit for adipose tissue, Baseline and day 1, 3 and 7 (final visit) for lymphocytes.
Secondary outcomes (8)
Change in plasma concentrations of fatty acids
Measurement of fatty acid content in plasma
Measured: Baseline, Day 1, Day 3 and Day 7 (final visit)
Change in plasma activity indices of steaoryl-CoA desaturase
Calculated based onthe ratio of plasma concentrations of products and precursors
Measured: Baseline, Day 1, Day 3 and Day 7 (final visit)
Change in protein expression of steaoryl CoA-desaturase in adipose tissue
Measurement of protein expression of steaoryl CoA-desaturase in adipose tissue
Measured: Baseline and Day 7 (final visit)
Change in protein expression of steaoryl CoA-desaturase in lymphocytes
Measurement of protein expression of steaoryl CoA-desaturase in lymphocytes
Measured: Baseline, Day 1, Day 3 and Day 7 (final visit)
Change in steaoryl CoA-desaturase activity in adipose tissue
Measurement of enzyme activity of steaoryl CoA-desaturase in adipose tissue
Measured: Baseline and Day 7 (final visit)
Diet feasibility
Diet feasibility will be measured by a self-administered questionnaire
Measured: Baseline, Day 1, Day 3 and Day 7 (final visit)
Diet compliance
Compliance with the diet will be measured by a self-administered questionnaire
Measured: Baseline, Day 1, Day 3 and Day 7 (final visit)
Body composition
Measurement of body composition by bioimpedance and dual X-ray absorptometry
Measured: Baseline and day 7 (final visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2018
- Study start8 Oct 2018
- Primary completion11 Dec 2018
- Study completion11 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 19 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
- NCT03629392
- Sponsor's protocol ID
- 239948-B
- Status last verified
- Mar 2020
- First submitted
- 2 Aug 2018
- Last updated
- 25 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Olsen T, Ovrebo B, Haj-Yasein N, Lee S, Svendsen K, Hjorth M, Bastani NE, Norheim F, Drevon CA, Refsum H, Vinknes KJ. Effects of dietary methionine and cysteine restriction on plasma biomarkers, serum fibroblast growth factor 21, and adipose tissue gene expression in women with overweight or obesity: a double-blind randomized controlled pilot study. J Transl Med. 2020 Mar 11;18(1):122. doi: 10.1186/s12967-020-02288-x.
PubMed 32160926Elshorbagy 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 36542145
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Methionine and Cysteine Restriction in Overweight Human Subjects
- ClinicalTrials.gov ID
- NCT03629392
- Acronym / sponsor ID
- 239948-B
- Conditions
- Overweight
- Keywords
- Methionine, Cysteine, Energy metabolism, Sulfur amino acids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of OsloUniversity, hospital or other
- Collaborators
- The Research Council of Norway, University of Oxford
- Study start
- 8 Oct 2018 (actual)
- Primary completion
- 11 Dec 2018 (actual)
- Study completion
- 11 Dec 2018 (actual)
- First posted
- 14 Aug 2018 (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 aim of this study is to examine the effect of methionine and cysteine restriction on energy and macronutrient metabolism in overweight human subjects
Detailed description
The sulfur-containing amino acid methionine and its downstream metabolite cysteine has been associated with fat mass in animal studies and human observational studies. Some of the proposed mechanisms include an association with lipogenesis, insulin sensitivity and disrupted energy metabolism.
The overall aim of this project is to evaluate the effects of a diet low in methionine and cysteine on markers of lipids, amino acids, glucose and other biomarkers related to energy metabolism, including transcriptomic and protein expression data from adipose tissue and lymphocytes. Overweight and obese but otherwise healthy volunteers will be randomized to receive a diet either low, moderate or high in methionine and cysteine concentrations for 1 week.
This is a pilot study that may be considered an extension of NCT02647970. In addition to the primary and secondary outcomes we will evaluate the feasibility of the intervention and procedures.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low met/cys diet | Experimental | Behavioral: Low met/cys dietDietary intervention |
| Moderate met/cys diet | Experimental | Behavioral: Moderate met/cys dietDietary intervention |
| High met/cys diet | Active comparator | Behavioral: High met/cys dietDietary intervention |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Body mass index of 25-35 kg/m2
Key exclusion criteria (5 listed)
- High physical activity
- Smoking
- Drugs
- Chronic disease
- 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 |
|---|---|---|
| Low met/cys dietDietary intervention with low contents of methionine and cysteine | Behavioural | Low met/cys diet |
| Moderate met/cys dietDietary intervention with moderate contents of methionine and cysteine | Behavioural | Moderate met/cys diet |
| High met/cys dietDietary intervention with high contents of methionine and cysteine | Behavioural | High met/cys diet |
Primary outcome
Change in plasma concentrations of amino acids
Time frame: Baseline, Day 1, Day 3 and Day 7 (final visit)
Measurement of biomarkers of amino acid metabolism, including plasma concentrations of methionine, cysteine and related metabolites
Change in protein expression activity in tissues
Time frame: Baseline and day 7 (final visit for adipose tissue, Baseline and day 1, 3 and 7 (final visit) for lymphocytes.
Measurement of protein expression and activity related to methionine and cysteine metabolism in adipose tissue and lymphocytes.
8 secondary outcomes
Change in plasma concentrations of fatty acids
Time frame: Baseline, Day 1, Day 3 and Day 7 (final visit)
Change in plasma activity indices of steaoryl-CoA desaturase
Time frame: Baseline, Day 1, Day 3 and Day 7 (final visit)
Change in protein expression of steaoryl CoA-desaturase in adipose tissue
Time frame: Baseline and Day 7 (final visit)
Change in protein expression of steaoryl CoA-desaturase in lymphocytes
Time frame: Baseline, Day 1, Day 3 and Day 7 (final visit)
Change in steaoryl CoA-desaturase activity in adipose tissue
Time frame: Baseline and Day 7 (final visit)
Diet feasibility
Time frame: Baseline, Day 1, Day 3 and Day 7 (final visit)
Diet compliance
Time frame: Baseline, Day 1, Day 3 and Day 7 (final visit)
Body composition
Time frame: Baseline and day 7 (final visit)
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 25 Mar 2020.
- Results publication: PubMed 32160926Olsen T, Ovrebo B, Haj-Yasein N, Lee S, Svendsen K, Hjorth M, Bastani NE, Norheim F, Drevon CA, Refsum H, Vinknes KJ. Effects of dietary methionine and cysteine restriction on plasma biomarkers, serum fibroblast growth factor 21, and adipose tissue gene expression in women with overweight or obesity: a double-blind randomized controlled pilot study. J Transl Med. 2020 Mar 11;18(1):122. doi: 10.1186/s12967-020-02288-x.
- 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.
Related trials for Overweight
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
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 Low met/cys diet, Moderate met/cys diet and High met/cys diet in people with Overweight, 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 5 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 25 Mar 2020. 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 plasma concentrations of amino acids (time frame: Baseline, Day 1, Day 3 and Day 7 (final visit)). The study lists 2 primary outcomes in all. 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 NCT03629392, which also lists 2 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 25 Mar 2020.