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Completed

NCT Number: NCT04701346

Sulfur Amino Acids, 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.

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Key information

Conditions

Overweight and Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre for Clinical Nutrition, University of Oslo/Oslo University Hospital

Oslo, 0372, Norway

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low SAA diet

Other

Diet with low content of methionine and cysteine

High SAA diet

Other

Diet with high content of methionine and cysteine

Primary outcomes

  1. Changes in body weight

    Time frame: At baseline, 4 and 8 weeks

    Kilograms

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Oslo

Other

Collaborators

  • Charles University, Czech Republic
  • Maastricht University
  • University of Oxford

Registry information

Official study title

Dietary Sulfur Amino Acid Restriction, Energy Metabolism and Obesity

Acronym: STAY

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 8, 2021
Registry last updated
May 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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