Overweight and ObesitySTAYNCT04701346
Sulfur Amino Acids, Energy Metabolism and Obesity
A study testing Low SAA diet and High SAA diet in people with Overweight and Obesity, run by University of Oslo at 1 site in Norway.
Trial summary
The primary objective of the trial is to establish the effects of dietary sulfur amino acid (SAA) restriction on body weight, body composition and energy expenditure in humans. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Low SAA diet and High SAA diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteNorway
- Study dates
- 1 Mar 2021to 17 Mar 2022
- 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy participants with overweight and obesity (BMI 27-35 kg/m2)
- Waist circumference > 80 cm for women and > 94 cm for men
Who cannot join
- Smoking
- Presence of chronic disease
- Established co-morbidities
- Already on a vegan diet or have been the last month
- Pregnancy
- Breastfeeding the last 3 months
- Unstable body weight the last 3 months
- High intensity training > 3 times weekly
Trial locations and contacts
1 site in 1 country.
Norway1 site
Centre for Clinical Nutrition, University of Oslo/Oslo University Hospital
Oslo, 0372
About this study
Official title: Dietary Sulfur Amino Acid Restriction, Energy Metabolism and Obesity
The primary objective of the trial is to establish the effects of dietary sulfur amino acid (SAA) restriction on body weight, body composition and energy expenditure in humans.
Read the detailed description
Dietary SAA restriction is an established model for increasing lifespan and improving metabolic health in animal studies. Data from human studies are limited.
In this study the investigators will perform an 8-week dietary intervention with SAA restriction to characterise the effects on several parameters related to metabolic health including body weight, body composition, energy expenditure, lipid profile and gene expression profiles in adipose tissue. The aim is to translate findings from previous animal experiments to humans
- Conditions
- Overweight and Obesity
- Being tested
- Low SAA diet, High SAA diet
- Keywords
- Methionine, Cysteine, Sulfur amino acids, Dietary intervention, Plant-based diet
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low SAA dietOther
Diet with low content of methionine and cysteine
High SAA dietOther
Diet with high content of methionine and cysteine
| Study group | Role | What they receive |
|---|---|---|
| Low SAA diet | Experimental | Dietary intervention Receives: Other: Low SAA diet |
| High SAA diet | Active comparator | Dietary intervention Receives: Other: High SAA diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in body weight
Kilograms
Measured: At baseline, 4 and 8 weeks
Secondary outcomes (15)
Changes in resting energy expenditure
Kilocalories
Measured: At baseline, 4 and 8 weeks
Changes in substrate oxidation
Respiratory quotient
Measured: At baseline, 4 and 8 weeks
Changes in body composition
Fat mass (kilograms) and lean mass (kilograms)
Measured: At baseline, 4 and 8 weeks
Changes in plasma concentrations of SAA and related intermediates and compounds
Sulfite, thiosulfate, rhodanide, sulfate, total aminothiols (homocysteine, cysteine, glutathione gamma-glutamylcysteine, cysteinylglycine, cysteamine), and fractions of total cysteine, total glutathione and total homocysteine, cystathionine, lanthionine, homolanthionine, taurine hypotaurine, sarcosine, hydrogen sulfide, S-adenosylmethionine and S-adenosylhomocysteine
Measured: At baseline, 4 and 8 weeks
Changes in urine concentrations of SAA and related intermediates and compounds
Including sulfite, thiosulfate, rhodanide, sulfate, total aminothiols (homocysteine, cysteine, glutathione gamma-glutamylcysteine, cysteinylglycine, cysteamine)
Measured: At baseline, 4 and 8 weeks
Changes in concentrations of plasma lipid profile
Fatty acids, total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides, ApoA1, ApoB
Measured: At baseline, 4 and 8 weeks
Changes in plasma makers of insulin sensitivity
Concentrations of glucose and insulin
Measured: At baseline, 4 and 8 weeks
Changes in plasma concentrations of adipokines and appetite hormones
Leptin, adiponectin, gastrin, ghrelin, cholecystokinin (CCK), glucagon-like peptide (GLP-1), oxyntomodulin, gastric inhibitory peptide (GIP), peptide YY (PYY), and pancreatic peptide (PP).
Measured: At baseline, 4 and 8 weeks
Changes in gene expression
mRNA of proteins involved in SAA metabolism, lipid and energy metabolism in leucocytes and subcutaneous white adipose tissue samples
Measured: At baseline, 4 and 8 weeks
Vitamin status
Plasma concentrations of folate, B12 and methylmalonic acid (MMA)
Measured: At baseline, 4 and 8 weeks
Changes in biomarkers related to obesity and energy metabolism
Untargeted analyses of plasma, serum and tissue concentrations
Measured: At baseline, 4 and 8 weeks
Changes in fibroblast growth factor 21 (FGF21)
Serum concentrations
Measured: At baseline, 4 and 8 weeks
Nitrogen balance
24 h-urine urea nitrogen
Measured: At baseline, 4 and 8 weeks
Changes in gut microbiota
Sequencing of fecal samples
Measured: At baseline, 4 and 8 weeks
Changes in short chain fatty acids
Fecal concentrations
Measured: At baseline, 4 and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2021
- Study start1 Mar 2021
- Primary completion17 Mar 2022
- Study completion17 Mar 2022
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 Overweight and ObesityStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oslo
- Sponsor type
- University, hospital or other
- Collaborators
- Charles University, Czech Republic, Maastricht University, University of Oxford
- Responsible party
- Principal investigator, Kathrine Vinknes, University of Oslo
- Investigators
- Kjetil Dr Retterstøl, Prof. dr med, Study director, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04701346
- Sponsor's protocol ID
- 310475
- Acronym
- STAY
- Status last verified
- May 2022
- First submitted
- 5 Jan 2021
- Last updated
- 19 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: EU privacy regulations do not permit public sharing of IPD as long as the project is ongoing. Anonymized data can be shared after the project and biobank permissions end in 2030. The study protocol will be published.
Publications
Olsen T, Vinknes KJ, Barvikova K, Stolt E, Lee-Odegard S, Troensegaard H, Johannessen H, Elshorbagy A, Sokolova J, Krijt J, Krizkova M, Ditroi T, Nagy P, Ovrebo B, Refsum H, Thoresen M, Retterstol K, Kozich V. Dietary sulfur amino acid restriction in humans with overweight and obesity: Evidence of an altered plasma and urine sulfurome, and a novel metabolic signature that correlates with loss of fat mass and adipose tissue gene expression. Redox Biol. 2024 Jul;73:103192. doi: 10.1016/j.redox.2024.103192. Epub 2024 May 17.
PubMed 38776754Olsen T, Stolt E, Ovrebo B, Elshorbagy A, Tore EC, Lee-Odegard S, Troensegaard H, Johannessen H, Doeland B, Vo AAD, Dahl AF, Svendsen K, Thoresen M, Refsum H, Rising R, Barvikova K, van Greevenbroek M, Kozich V, Retterstol K, Vinknes KJ. Dietary sulfur amino acid restriction in humans with overweight and obesity: a translational randomized controlled trial. J Transl Med. 2024 Jan 9;22(1):40. doi: 10.1186/s12967-023-04833-w.
PubMed 38195568Stolt E, Olsen T, Elshorbagy A, Kozich V, van Greevenbroek M, Ovrebo B, Thoresen M, Refsum H, Retterstol K, Vinknes KJ. Sulfur amino acid restriction, energy metabolism and obesity: a study protocol of an 8-week randomized controlled dietary intervention with whole foods and amino acid supplements. J Transl Med. 2021 Apr 15;19(1):153. doi: 10.1186/s12967-021-02824-3.
PubMed 33858441
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Sulfur Amino Acid Restriction, Energy Metabolism and Obesity
- ClinicalTrials.gov ID
- NCT04701346
- Acronym / sponsor ID
- STAY / 310475
- Conditions
- Overweight and Obesity
- Keywords
- Methionine, Cysteine, Sulfur amino acids, Dietary intervention, Plant-based diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- University of OsloUniversity, hospital or other
- Collaborators
- Charles University, Czech Republic, Maastricht University, University of Oxford
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 17 Mar 2022 (actual)
- Study completion
- 17 Mar 2022 (actual)
- First posted
- 8 Jan 2021 (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 primary objective of the trial is to establish the effects of dietary sulfur amino acid (SAA) restriction on body weight, body composition and energy expenditure in humans.
Detailed description
Dietary SAA restriction is an established model for increasing lifespan and improving metabolic health in animal studies. Data from human studies are limited.
In this study the investigators will perform an 8-week dietary intervention with SAA restriction to characterise the effects on several parameters related to metabolic health including body weight, body composition, energy expenditure, lipid profile and gene expression profiles in adipose tissue. The aim is to translate findings from previous animal experiments to humans
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low SAA diet | Experimental | Other: Low SAA dietDietary intervention |
| High SAA diet | Active comparator | Other: High SAA dietDietary intervention |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy participants with overweight and obesity (BMI 27-35 kg/m2)
- Waist circumference > 80 cm for women and > 94 cm for men
Key exclusion criteria (8 listed)
- Smoking
- Presence of chronic disease
- Established co-morbidities
- Already on a vegan diet or have been the last month
- Pregnancy
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 SAA dietDiet with low content of methionine and cysteine | Other | Low SAA diet |
| High SAA dietDiet with high content of methionine and cysteine | Other | High SAA diet |
Primary outcome
Changes in body weight
Time frame: At baseline, 4 and 8 weeks
Kilograms
15 secondary outcomes
Changes in resting energy expenditure
Time frame: At baseline, 4 and 8 weeks
Changes in substrate oxidation
Time frame: At baseline, 4 and 8 weeks
Changes in body composition
Time frame: At baseline, 4 and 8 weeks
Changes in plasma concentrations of SAA and related intermediates and compounds
Time frame: At baseline, 4 and 8 weeks
Changes in urine concentrations of SAA and related intermediates and compounds
Time frame: At baseline, 4 and 8 weeks
Changes in concentrations of plasma lipid profile
Time frame: At baseline, 4 and 8 weeks
Changes in plasma makers of insulin sensitivity
Time frame: At baseline, 4 and 8 weeks
Changes in plasma concentrations of adipokines and appetite hormones
Time frame: At baseline, 4 and 8 weeks
Changes in gene expression
Time frame: At baseline, 4 and 8 weeks
Vitamin status
Time frame: At baseline, 4 and 8 weeks
Changes in biomarkers related to obesity and energy metabolism
Time frame: At baseline, 4 and 8 weeks
Changes in fibroblast growth factor 21 (FGF21)
Time frame: At baseline, 4 and 8 weeks
Nitrogen balance
Time frame: At baseline, 4 and 8 weeks
Changes in gut microbiota
Time frame: At baseline, 4 and 8 weeks
Changes in short chain fatty acids
Time frame: At baseline, 4 and 8 weeks
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 19 May 2022.
- Derived from this study: PubMed 38776754Olsen T, Vinknes KJ, Barvikova K, Stolt E, Lee-Odegard S, Troensegaard H, Johannessen H, Elshorbagy A, Sokolova J, Krijt J, Krizkova M, Ditroi T, Nagy P, Ovrebo B, Refsum H, Thoresen M, Retterstol K, Kozich V. Dietary sulfur amino acid restriction in humans with overweight and obesity: Evidence of an altered plasma and urine sulfurome, and a novel metabolic signature that correlates with loss of fat mass and adipose tissue gene expression. Redox Biol. 2024 Jul;73:103192. doi: 10.1016/j.redox.2024.103192. Epub 2024 May 17.
- Derived from this study: PubMed 38195568Olsen T, Stolt E, Ovrebo B, Elshorbagy A, Tore EC, Lee-Odegard S, Troensegaard H, Johannessen H, Doeland B, Vo AAD, Dahl AF, Svendsen K, Thoresen M, Refsum H, Rising R, Barvikova K, van Greevenbroek M, Kozich V, Retterstol K, Vinknes KJ. Dietary sulfur amino acid restriction in humans with overweight and obesity: a translational randomized controlled trial. J Transl Med. 2024 Jan 9;22(1):40. doi: 10.1186/s12967-023-04833-w.
- Derived from this study: PubMed 33858441Stolt E, Olsen T, Elshorbagy A, Kozich V, van Greevenbroek M, Ovrebo B, Thoresen M, Refsum H, Retterstol K, Vinknes KJ. Sulfur amino acid restriction, energy metabolism and obesity: a study protocol of an 8-week randomized controlled dietary intervention with whole foods and amino acid supplements. J Transl Med. 2021 Apr 15;19(1):153. doi: 10.1186/s12967-021-02824-3.
- Individual participant dataSharing planned: No. EU privacy regulations do not permit public sharing of IPD as long as the project is ongoing. Anonymized data can be shared after the project and biobank permissions end in 2030. The study protocol will be published.
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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.
Kjetil Dr Retterstøl, Prof. dr med study director
University of Oslo
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 SAA diet and High SAA diet in people with Overweight 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 2 inclusion and 8 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 19 May 2022. 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?
Changes in body weight (time frame: At baseline, 4 and 8 weeks). 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 NCT04701346, 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 19 May 2022.