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| Name | Class |
|---|---|
| Charles University, Czech Republic | OTHER |
| Maastricht University | OTHER |
| University of Oxford | OTHER |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low SAA diet | Experimental | Dietary intervention |
|
| High SAA diet | Active Comparator | Dietary intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low SAA diet | Other | Diet with low content of methionine and cysteine |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in body weight | Kilograms | At baseline, 4 and 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in resting energy expenditure | Kilocalories | At baseline, 4 and 8 weeks |
| Changes in substrate oxidation | Respiratory quotient |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kjetil Dr Retterstøl, Prof. dr med | University of Oslo | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Clinical Nutrition, University of Oslo/Oslo University Hospital | Oslo | 0372 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38776754 | Derived | 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. | |
| 38195568 |
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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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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| High SAA diet |
| Other |
Diet with high content of methionine and cysteine |
|
| At baseline, 4 and 8 weeks |
| Changes in body composition | Fat mass (kilograms) and lean mass (kilograms) | 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 | 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) | At baseline, 4 and 8 weeks |
| Changes in concentrations of plasma lipid profile | Fatty acids, total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides, ApoA1, ApoB | At baseline, 4 and 8 weeks |
| Changes in plasma makers of insulin sensitivity | Concentrations of glucose and insulin | 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). | 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 | At baseline, 4 and 8 weeks |
| Vitamin status | Plasma concentrations of folate, B12 and methylmalonic acid (MMA) | At baseline, 4 and 8 weeks |
| Changes in biomarkers related to obesity and energy metabolism | Untargeted analyses of plasma, serum and tissue concentrations | At baseline, 4 and 8 weeks |
| Changes in fibroblast growth factor 21 (FGF21) | Serum concentrations | At baseline, 4 and 8 weeks |
| Nitrogen balance | 24 h-urine urea nitrogen | At baseline, 4 and 8 weeks |
| Changes in gut microbiota | Sequencing of fecal samples | At baseline, 4 and 8 weeks |
| Changes in short chain fatty acids | Fecal concentrations | At baseline, 4 and 8 weeks |
| Derived |
| Olsen 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. |
| 33858441 | Derived | Stolt 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. |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |