Clinical trial NCT04701346: Sulfur Amino Acids, Energy Metabolism and Obesity
Official title: Dietary Sulfur Amino Acid Restriction, Energy Metabolism and Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Keywords: Methionine
Cysteine
Sulfur amino acids
Dietary intervention
Plant-based diet
Lead sponsor: University of Oslo
Sponsor class: OTHER
Collaborators: name: Charles University, Czech Republic
name: Maastricht University
name: University of Oxford
First posted: 2021-01-08
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility 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

Primary outcomes:
measure: Changes in body weight
timeFrame: At baseline, 4 and 8 weeks
Secondary outcomes:
measure: Changes in resting energy expenditure
timeFrame: At baseline, 4 and 8 weeks
measure: Changes in substrate oxidation
timeFrame: At baseline, 4 and 8 weeks
measure: Changes in body composition
timeFrame: At baseline, 4 and 8 weeks
measure: Changes in plasma concentrations of SAA and related intermediates and compounds
timeFrame: At baseline, 4 and 8 weeks
measure: Changes in urine concentrations of SAA and related intermediates and compounds
timeFrame: At baseline, 4 and 8 weeks
measure: Changes in concentrations of plasma lipid profile
timeFrame: At baseline, 4 and 8 weeks
measure: Changes in plasma makers of insulin sensitivity
timeFrame: At baseline, 4 and 8 weeks
measure: Changes in plasma concentrations of adipokines and appetite hormones
timeFrame: At baseline, 4 and 8 weeks
measure: Changes in gene expression
timeFrame: At baseline, 4 and 8 weeks
measure: Vitamin status
timeFrame: At baseline, 4 and 8 weeks
measure: Changes in biomarkers related to obesity and energy metabolism
timeFrame: At baseline, 4 and 8 weeks
measure: Changes in fibroblast growth factor 21 (FGF21)
timeFrame: At baseline, 4 and 8 weeks
measure: Nitrogen balance
timeFrame: At baseline, 4 and 8 weeks
measure: Changes in gut microbiota
timeFrame: At baseline, 4 and 8 weeks
measure: Changes in short chain fatty acids
timeFrame: At baseline, 4 and 8 weeks
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Centre for Clinical Nutrition, University of Oslo/Oslo University Hospital
Study officials:
affiliation: University of Oslo
name: Kjetil Dr Retterstøl, Prof. dr med
role: STUDY_DIRECTOR
References:
citation: Stolt E, Olsen T, Elshorbagy A, Kozich V, van Greevenbroek M, Ovrebo B, Thoresen M, Refsum H, Retterstol 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.