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Sulfur Amino Acids, Energy Metabolism and Obesity (STAY)

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ClinicalTrials.gov Identifier: NCT04701346
Recruitment Status : Recruiting
First Posted : January 8, 2021
Last Update Posted : April 13, 2021
Sponsor:
Collaborators:
Charles University, Czech Republic
Maastricht University
University of Oxford
Information provided by (Responsible Party):
Kathrine Vinknes, University of Oslo

Tracking Information
First Submitted Date  ICMJE January 5, 2021
First Posted Date  ICMJE January 8, 2021
Last Update Posted Date April 13, 2021
Actual Study Start Date  ICMJE March 1, 2021
Estimated Primary Completion Date August 31, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 5, 2021)
Changes in body weight [ Time Frame: At baseline, 4 and 8 weeks ]
Kilograms
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 8, 2021)
  • Changes in resting energy expenditure [ Time Frame: At baseline, 4 and 8 weeks ]
    Kilocalories
  • Changes in substrate oxidation [ Time Frame: At baseline, 4 and 8 weeks ]
    Respiratory quotient
  • Changes in body composition [ Time Frame: At baseline, 4 and 8 weeks ]
    Fat mass (kilograms) and lean mass (kilograms)
  • Changes in plasma concentrations of SAA and related intermediates and compounds [ Time Frame: At baseline, 4 and 8 weeks ]
    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
  • Changes in urine concentrations of SAA and related intermediates and compounds [ Time Frame: At baseline, 4 and 8 weeks ]
    Including sulfite, thiosulfate, rhodanide, sulfate, total aminothiols (homocysteine, cysteine, glutathione gamma-glutamylcysteine, cysteinylglycine, cysteamine)
  • Changes in concentrations of plasma lipid profile [ Time Frame: At baseline, 4 and 8 weeks ]
    Fatty acids, total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides, ApoA1, ApoB
  • Changes in plasma makers of insulin sensitivity [ Time Frame: At baseline, 4 and 8 weeks ]
    Concentrations of glucose and insulin
  • Changes in plasma concentrations of adipokines and appetite hormones [ Time Frame: At baseline, 4 and 8 weeks ]
    Leptin, adiponectin, gastrin, ghrelin, cholecystokinin (CCK), glucagon-like peptide (GLP-1), oxyntomodulin, gastric inhibitory peptide (GIP), peptide YY (PYY), and pancreatic peptide (PP).
  • Changes in gene expression [ Time Frame: At baseline, 4 and 8 weeks ]
    mRNA of proteins involved in SAA metabolism, lipid and energy metabolism in leucocytes and subcutaneous white adipose tissue samples
  • Vitamin status [ Time Frame: At baseline, 4 and 8 weeks ]
    Plasma concentrations of folate, B12 and methylmalonic acid (MMA)
  • Changes in biomarkers related to obesity and energy metabolism [ Time Frame: At baseline, 4 and 8 weeks ]
    Untargeted analyses of plasma, serum and tissue concentrations
  • Changes in fibroblast growth factor 21 (FGF21) [ Time Frame: At baseline, 4 and 8 weeks ]
    Serum concentrations
  • Nitrogen balance [ Time Frame: At baseline, 4 and 8 weeks ]
    24 h-urine urea nitrogen
  • Changes in gut microbiota [ Time Frame: At baseline, 4 and 8 weeks ]
    Sequencing of fecal samples
  • Changes in short chain fatty acids [ Time Frame: At baseline, 4 and 8 weeks ]
    Fecal concentrations
Original Secondary Outcome Measures  ICMJE
 (submitted: January 5, 2021)
  • Changes in resting energy expenditure [ Time Frame: At baseline, 4 and 8 weeks ]
    Kilocalories
  • Changes in substrate oxidation [ Time Frame: At baseline, 4 and 8 weeks ]
    Respiratory quotient
  • Changes in body composition [ Time Frame: At baseline, 4 and 8 weeks ]
    Fat mass (kilograms) and lean mass (kilograms)
  • Changes in plasma concentrations of SAA and related intermediates and compounds [ Time Frame: At baseline, 4 and 8 weeks ]
    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 ( H2S), S-adenosylmethionine and S-adenosylhomocysteine
  • Changes in urine concentrations of SAA and related intermediates and compounds [ Time Frame: At baseline, 4 and 8 weeks ]
    Including sulfite, thiosulfate, rhodanide, sulfate, total aminothiols (homocysteine, cysteine, glutathione gamma-glutamylcysteine, cysteinylglycine, cysteamine)
  • Changes in concentrations of plasma lipid profile [ Time Frame: At baseline, 4 and 8 weeks ]
    Fatty acids, total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides, ApoA1, ApoB
  • Changes in plasma makers of insulin sensitivity [ Time Frame: At baseline, 4 and 8 weeks ]
    Concentrations of glucose and insulin
  • Changes in plasma concentrations of adipokines and appetite hormones [ Time Frame: At baseline, 4 and 8 weeks ]
    Leptin, adiponectin, gastrin, ghrelin, cholecystokinin (CCK), glucagon-like peptide (GLP-1), oxyntomodulin, gastric inhibitory peptide (GIP), peptide YY (PYY), and pancreatic peptide (PP).
  • Changes in gene expression [ Time Frame: At baseline, 4 and 8 weeks ]
    mRNA of proteins involved in SAA metabolism, lipid and energy metabolism in leucocytes and subcutaneous white adipose tissue samples
  • Vitamin status [ Time Frame: At baseline, 4 and 8 weeks ]
    Plasma concentrations of folate, B12 and methylmalonic acid (MMA)
  • Changes in biomarkers related to obesity and energy metabolism [ Time Frame: At baseline, 4 and 8 weeks ]
    Untargeted analyses of plasma, serum and tissue concentrations
  • Changes in FGF21 [ Time Frame: At baseline, 4 and 8 weeks ]
    Serum concentrations
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sulfur Amino Acids, Energy Metabolism and Obesity
Official Title  ICMJE Dietary Sulfur Amino Acid Restriction, Energy Metabolism and Obesity
Brief 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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Overweight and Obesity
Intervention  ICMJE
  • Other: Low SAA diet
    Diet with low content of methionine and cysteine
  • Other: High SAA diet
    Diet with high content of methionine and cysteine
Study Arms  ICMJE
  • Experimental: Low SAA diet
    Dietary intervention
    Intervention: Other: Low SAA diet
  • Active Comparator: High SAA diet
    Dietary intervention
    Intervention: Other: High SAA diet
Publications * Stolt E, Olsen T, Elshorbagy A, Kožich V, van Greevenbroek M, Øvrebø B, Thoresen M, Refsum H, Retterstøl 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 5, 2021)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 31, 2023
Estimated Primary Completion Date August 31, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy participants with overweight and obesity (BMI 27-35 kg/m2)
  • Waist circumference > 80 cm for women and > 94 cm for men

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Thomas Olsen, PhD 004722851525 thomas.olsen@medisin.uio.no
Contact: Kathrine Vinknes, PhD 004722851525 kathrine.vinknes@medisin.uio.no
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04701346
Other Study ID Numbers  ICMJE 310475
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description:

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.

Responsible Party Kathrine Vinknes, University of Oslo
Study Sponsor  ICMJE University of Oslo
Collaborators  ICMJE
  • Charles University, Czech Republic
  • Maastricht University
  • University of Oxford
Investigators  ICMJE
Study Director: Kjetil Dr Retterstøl, Prof. dr med University of Oslo
PRS Account University of Oslo
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP