NCT03629392

Brief Summary

The aim of this study is to examine the effect of methionine and cysteine restriction on energy and macronutrient metabolism in overweight human subjects

Trial Health

87
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2018

Shorter than P25 for not_applicable

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

August 2, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 14, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

October 8, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 11, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 11, 2018

Completed
Last Updated

March 25, 2020

Status Verified

March 1, 2020

Enrollment Period

2 months

First QC Date

August 2, 2018

Last Update Submit

March 23, 2020

Conditions

Overweight

Keywords

MethionineCysteineEnergy metabolismSulfur amino acids

Outcome Measures

Primary Outcomes (2)

  • Change in plasma concentrations of amino acids

    Measurement of biomarkers of amino acid metabolism, including plasma concentrations of methionine, cysteine and related metabolites

    Baseline, Day 1, Day 3 and Day 7 (final visit)

  • Change in protein expression activity in tissues

    Measurement of protein expression and activity related to methionine and cysteine metabolism in adipose tissue and lymphocytes.

    Baseline and day 7 (final visit for adipose tissue, Baseline and day 1, 3 and 7 (final visit) for lymphocytes.

Secondary Outcomes (8)

  • Change in plasma concentrations of fatty acids

    Baseline, Day 1, Day 3 and Day 7 (final visit)

  • Change in plasma activity indices of steaoryl-CoA desaturase

    Baseline, Day 1, Day 3 and Day 7 (final visit)

  • Change in protein expression of steaoryl CoA-desaturase in adipose tissue

    Baseline and Day 7 (final visit)

  • Change in protein expression of steaoryl CoA-desaturase in lymphocytes

    Baseline, Day 1, Day 3 and Day 7 (final visit)

  • Change in steaoryl CoA-desaturase activity in adipose tissue

    Baseline and Day 7 (final visit)

  • +3 more secondary outcomes

Study Arms (3)

Low met/cys diet

EXPERIMENTAL

Dietary intervention

Behavioral: Low met/cys diet

Moderate met/cys diet

EXPERIMENTAL

Dietary intervention

Behavioral: Moderate met/cys diet

High met/cys diet

ACTIVE COMPARATOR

Dietary intervention

Behavioral: High met/cys diet

Interventions

Low met/cys dietBEHAVIORAL

Dietary intervention with low contents of methionine and cysteine

Low met/cys diet
Moderate met/cys dietBEHAVIORAL

Dietary intervention with moderate contents of methionine and cysteine

Moderate met/cys diet
High met/cys dietBEHAVIORAL

Dietary intervention with high contents of methionine and cysteine

High met/cys diet

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Body mass index of 25-35 kg/m2

You may not qualify if:

  • High physical activity
  • Smoking
  • Drugs
  • Chronic disease
  • Pregnancy or breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Oslo

Oslo, 0372, Norway

Location

Related Publications (2)

  • Olsen T, Ovrebo B, Haj-Yasein N, Lee S, Svendsen K, Hjorth M, Bastani NE, Norheim F, Drevon CA, Refsum H, Vinknes KJ. Effects of dietary methionine and cysteine restriction on plasma biomarkers, serum fibroblast growth factor 21, and adipose tissue gene expression in women with overweight or obesity: a double-blind randomized controlled pilot study. J Transl Med. 2020 Mar 11;18(1):122. doi: 10.1186/s12967-020-02288-x.

    PMID: 32160926RESULT

  • Elshorbagy A, Bastani NE, Lee-Odegard S, Ovrebo B, Haj-Yasein N, Svendsen K, Turner C, Refsum H, Vinknes KJ, Olsen T. The association of fasting plasma thiol fractions with body fat compartments, biomarker profile, and adipose tissue gene expression. Amino Acids. 2023 Mar;55(3):313-323. doi: 10.1007/s00726-022-03229-2. Epub 2022 Dec 21.

    PMID: 36542145DERIVED

MeSH Terms

Conditions

Overweight

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Participant: The diets are similar except for methionine and cysteine, and it is thought that the participants will not be able to identify their treatment allocation by taste. Investigator: Randomization will be carried out by an investigator that is not related to the study. All foods will be pre-packaged and delivered to the participants by an unrelated company.
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Kathrine Vinknes, PhD

Study Record Dates

First Submitted

August 2, 2018

First Posted

August 14, 2018

Study Start

October 8, 2018

Primary Completion

December 11, 2018

Study Completion

December 11, 2018

Last Updated

March 25, 2020

Record last verified: 2020-03

Locations

NO(1)