Sulfur Amino Acids, Energy Metabolism and Obesity

Not Applicable

Completed

• Conditions: Overweight and Obesity
• Interventions: Other: High SAA diet; Other: Low SAA diet

• Registration Number: NCT04701346
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2021-01-05
• Study First Submitted QC: 2021-01-05
• Study First Posted: 2021-01-08
• Study Start: 2021-03-01
• Primary Completion: 2022-03-17
• Study Completion: 2022-03-17
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-18
• Last Update Posted: 2022-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High SAA diet	High SAA diet	Dietary intervention
Low SAA diet	Low SAA diet	Dietary intervention

Primary Outcome Measures

Name	Time	Method
Changes in body weight	At baseline, 4 and 8 weeks	Kilograms

Secondary Outcome Measures

Name	Time	Method
Changes in resting energy expenditure	At baseline, 4 and 8 weeks	Kilocalories
Changes in plasma concentrations of SAA and related intermediates and compounds	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 concentrations of plasma lipid profile	At baseline, 4 and 8 weeks	Fatty acids, total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides, ApoA1, ApoB
Changes in plasma concentrations of adipokines and appetite hormones	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 fibroblast growth factor 21 (FGF21)	At baseline, 4 and 8 weeks	Serum concentrations
Changes in gut microbiota	At baseline, 4 and 8 weeks	Sequencing of fecal samples
Changes in body composition	At baseline, 4 and 8 weeks	Fat mass (kilograms) and lean mass (kilograms)
Changes in substrate oxidation	At baseline, 4 and 8 weeks	Respiratory quotient
Changes in urine concentrations of SAA and related intermediates and compounds	At baseline, 4 and 8 weeks	Including sulfite, thiosulfate, rhodanide, sulfate, total aminothiols (homocysteine, cysteine, glutathione gamma-glutamylcysteine, cysteinylglycine, cysteamine)
Changes in plasma makers of insulin sensitivity	At baseline, 4 and 8 weeks	Concentrations of glucose and insulin
Changes in biomarkers related to obesity and energy metabolism	At baseline, 4 and 8 weeks	Untargeted analyses of plasma, serum and tissue concentrations
Changes in gene expression	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	At baseline, 4 and 8 weeks	Plasma concentrations of folate, B12 and methylmalonic acid (MMA)
Changes in short chain fatty acids	At baseline, 4 and 8 weeks	Fecal concentrations
Nitrogen balance	At baseline, 4 and 8 weeks	24 h-urine urea nitrogen

Trial Locations

Locations (1)

Centre for Clinical Nutrition, University of Oslo/Oslo University Hospital; 🇳🇴 Oslo, Norway