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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

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.

Condition or disease Intervention/treatment Phase
Overweight and Obesity Other: Low SAA diet Other: High SAA diet Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Dietary Sulfur Amino Acid Restriction, Energy Metabolism and Obesity
Actual Study Start Date : March 1, 2021
Estimated Primary Completion Date : August 31, 2023
Estimated Study Completion Date : August 31, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Low SAA diet
Dietary intervention
Other: Low SAA diet
Diet with low content of methionine and cysteine

Active Comparator: High SAA diet
Dietary intervention
Other: High SAA diet
Diet with high content of methionine and cysteine




Primary Outcome Measures :
  1. Changes in body weight [ Time Frame: At baseline, 4 and 8 weeks ]
    Kilograms


Secondary Outcome Measures :
  1. Changes in resting energy expenditure [ Time Frame: At baseline, 4 and 8 weeks ]
    Kilocalories

  2. Changes in substrate oxidation [ Time Frame: At baseline, 4 and 8 weeks ]
    Respiratory quotient

  3. Changes in body composition [ Time Frame: At baseline, 4 and 8 weeks ]
    Fat mass (kilograms) and lean mass (kilograms)

  4. 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

  5. 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)

  6. 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

  7. Changes in plasma makers of insulin sensitivity [ Time Frame: At baseline, 4 and 8 weeks ]
    Concentrations of glucose and insulin

  8. 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).

  9. 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

  10. Vitamin status [ Time Frame: At baseline, 4 and 8 weeks ]
    Plasma concentrations of folate, B12 and methylmalonic acid (MMA)

  11. 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

  12. Changes in fibroblast growth factor 21 (FGF21) [ Time Frame: At baseline, 4 and 8 weeks ]
    Serum concentrations

  13. Nitrogen balance [ Time Frame: At baseline, 4 and 8 weeks ]
    24 h-urine urea nitrogen

  14. Changes in gut microbiota [ Time Frame: At baseline, 4 and 8 weeks ]
    Sequencing of fecal samples

  15. Changes in short chain fatty acids [ Time Frame: At baseline, 4 and 8 weeks ]
    Fecal concentrations



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04701346


Contacts
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Contact: Thomas Olsen, PhD 004722851525 thomas.olsen@medisin.uio.no
Contact: Kathrine Vinknes, PhD 004722851525 kathrine.vinknes@medisin.uio.no

Locations
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Norway
Centre for Clinical Nutrition, University of Oslo/Oslo University Hospital Recruiting
Oslo, Norway, 0372
Contact: Thomas Olsen, PhD       thomas.olsen@medisin.uio.no   
Contact: Kathrine J Vinknes, PhD       kathrine.vinknes@medisin.uio.no   
Sponsors and Collaborators
University of Oslo
Charles University, Czech Republic
Maastricht University
University of Oxford
Investigators
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Study Director: Kjetil Dr Retterstøl, Prof. dr med University of Oslo
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Kathrine Vinknes, Researcher, University of Oslo
ClinicalTrials.gov Identifier: NCT04701346    
Other Study ID Numbers: 310475
First Posted: January 8, 2021    Key Record Dates
Last Update Posted: April 13, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
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.


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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kathrine Vinknes, University of Oslo:
Methionine
Cysteine
Sulfur amino acids
Dietary intervention
Plant-based diet
Additional relevant MeSH terms:
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Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight