Sulfur Amino Acids, Energy Metabolism and Obesity

Overweight and Obesity Clinical Trial

— STAY  

Official title:

Dietary Sulfur Amino Acid Restriction, Energy Metabolism and Obesity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04701346
• Other study ID #: 310475
• Status: Completed
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: March 17, 2022

Study information

• Verified date: May 2022
• Source: University of Oslo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: March 17, 2022
• Est. primary completion date: March 17, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Overweight
• Overweight and Obesity

Intervention

Other:
• Low SAA diet
Diet with low content of methionine and cysteine
• High SAA diet
Diet with high content of methionine and cysteine

Locations

Country	Name	City	State
Norway	Centre for Clinical Nutrition, University of Oslo/Oslo University Hospital	Oslo

Sponsors (4)

Lead Sponsor	Collaborator
University of Oslo	Charles University, Czech Republic, Maastricht University, University of Oxford

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in body weight	Kilograms	At baseline, 4 and 8 weeks
Secondary	Changes in resting energy expenditure	Kilocalories	At baseline, 4 and 8 weeks
Secondary	Changes in substrate oxidation	Respiratory quotient	At baseline, 4 and 8 weeks
Secondary	Changes in body composition	Fat mass (kilograms) and lean mass (kilograms)	At baseline, 4 and 8 weeks
Secondary	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
Secondary	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
Secondary	Changes in concentrations of plasma lipid profile	Fatty acids, total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides, ApoA1, ApoB	At baseline, 4 and 8 weeks
Secondary	Changes in plasma makers of insulin sensitivity	Concentrations of glucose and insulin	At baseline, 4 and 8 weeks
Secondary	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
Secondary	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
Secondary	Vitamin status	Plasma concentrations of folate, B12 and methylmalonic acid (MMA)	At baseline, 4 and 8 weeks
Secondary	Changes in biomarkers related to obesity and energy metabolism	Untargeted analyses of plasma, serum and tissue concentrations	At baseline, 4 and 8 weeks
Secondary	Changes in fibroblast growth factor 21 (FGF21)	Serum concentrations	At baseline, 4 and 8 weeks
Secondary	Nitrogen balance	24 h-urine urea nitrogen	At baseline, 4 and 8 weeks
Secondary	Changes in gut microbiota	Sequencing of fecal samples	At baseline, 4 and 8 weeks
Secondary	Changes in short chain fatty acids	Fecal concentrations	At baseline, 4 and 8 weeks