NCT04701346

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 5, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 8, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 17, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 17, 2022

Completed
Last Updated

May 19, 2022

Status Verified

May 1, 2022

Enrollment Period

1 year

First QC Date

January 5, 2021

Last Update Submit

May 18, 2022

Conditions

Overweight and Obesity

Keywords

MethionineCysteineSulfur amino acidsDietary interventionPlant-based diet

Outcome Measures

Primary Outcomes (1)

  • Changes in body weight

    Kilograms

    At baseline, 4 and 8 weeks

Secondary Outcomes (15)

  • Changes in resting energy expenditure

    At baseline, 4 and 8 weeks

  • Changes in substrate oxidation

    At baseline, 4 and 8 weeks

  • Changes in body composition

    At baseline, 4 and 8 weeks

  • Changes in plasma concentrations of SAA and related intermediates and compounds

    At baseline, 4 and 8 weeks

  • Changes in urine concentrations of SAA and related intermediates and compounds

    At baseline, 4 and 8 weeks

  • +10 more secondary outcomes

Study Arms (2)

Low SAA diet

EXPERIMENTAL

Dietary intervention

Other: Low SAA diet

High SAA diet

ACTIVE COMPARATOR

Dietary intervention

Other: High SAA diet

Interventions

Low SAA dietOTHER

Diet with low content of methionine and cysteine

Low SAA diet
High SAA dietOTHER

Diet with high content of methionine and cysteine

High SAA diet

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy participants with overweight and obesity (BMI 27-35 kg/m2)
  • Waist circumference \> 80 cm for women and \> 94 cm for men

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Oslo, 0372, Norway

Location

Related Publications (3)

  • Olsen T, Vinknes KJ, Barvikova K, Stolt E, Lee-Odegard S, Troensegaard H, Johannessen H, Elshorbagy A, Sokolova J, Krijt J, Krizkova M, Ditroi T, Nagy P, Ovrebo B, Refsum H, Thoresen M, Retterstol K, Kozich V. Dietary sulfur amino acid restriction in humans with overweight and obesity: Evidence of an altered plasma and urine sulfurome, and a novel metabolic signature that correlates with loss of fat mass and adipose tissue gene expression. Redox Biol. 2024 Jul;73:103192. doi: 10.1016/j.redox.2024.103192. Epub 2024 May 17.

    PMID: 38776754DERIVED

  • Olsen T, Stolt E, Ovrebo B, Elshorbagy A, Tore EC, Lee-Odegard S, Troensegaard H, Johannessen H, Doeland B, Vo AAD, Dahl AF, Svendsen K, Thoresen M, Refsum H, Rising R, Barvikova K, van Greevenbroek M, Kozich V, Retterstol K, Vinknes KJ. Dietary sulfur amino acid restriction in humans with overweight and obesity: a translational randomized controlled trial. J Transl Med. 2024 Jan 9;22(1):40. doi: 10.1186/s12967-023-04833-w.

    PMID: 38195568DERIVED

  • 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.

    PMID: 33858441DERIVED

MeSH Terms

Conditions

OverweightObesity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Kjetil Dr Retterstøl, Prof. dr med

    University of Oslo

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

January 5, 2021

First Posted

January 8, 2021

Study Start

March 1, 2021

Primary Completion

March 17, 2022

Study Completion

March 17, 2022

Last Updated

May 19, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

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.

Locations

NO(1)