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Methionine and Cysteine Restriction in Humans

Primary Purpose

Overweight

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Low met/cys diet
Moderate met/cys diet
High met/cys diet
Sponsored by
University of Oslo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Overweight focused on measuring Methionine, Cysteine, Energy metabolism, Sulfur amino acids

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Body mass index of 25-35 kg/m2

Exclusion Criteria:

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

Sites / Locations

  • University of Oslo

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Low met/cys diet

Moderate met/cys diet

High met/cys diet

Arm Description

Dietary intervention

Dietary intervention

Dietary intervention

Outcomes

Primary Outcome Measures

Change in plasma concentrations of amino acids
Measurement of biomarkers of amino acid metabolism, including plasma concentrations of methionine, cysteine and related metabolites
Change in protein expression activity in tissues
Measurement of protein expression and activity related to methionine and cysteine metabolism in adipose tissue and lymphocytes.

Secondary Outcome Measures

Change in plasma concentrations of fatty acids
Measurement of fatty acid content in plasma
Change in plasma activity indices of steaoryl-CoA desaturase
Calculated based onthe ratio of plasma concentrations of products and precursors
Change in protein expression of steaoryl CoA-desaturase in adipose tissue
Measurement of protein expression of steaoryl CoA-desaturase in adipose tissue
Change in protein expression of steaoryl CoA-desaturase in lymphocytes
Measurement of protein expression of steaoryl CoA-desaturase in lymphocytes
Change in steaoryl CoA-desaturase activity in adipose tissue
Measurement of enzyme activity of steaoryl CoA-desaturase in adipose tissue
Diet feasibility
Diet feasibility will be measured by a self-administered questionnaire
Diet compliance
Compliance with the diet will be measured by a self-administered questionnaire
Body composition
Measurement of body composition by bioimpedance and dual X-ray absorptometry

Full Information

First Posted
August 2, 2018
Last Updated
March 23, 2020
Sponsor
University of Oslo
Collaborators
The Research Council of Norway, University of Oxford
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1. Study Identification

Unique Protocol Identification Number
NCT03629392
Brief Title
Methionine and Cysteine Restriction in Humans
Official Title
Dietary Methionine and Cysteine Restriction in Overweight Human Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
October 8, 2018 (Actual)
Primary Completion Date
December 11, 2018 (Actual)
Study Completion Date
December 11, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Oslo
Collaborators
The Research Council of Norway, University of Oxford

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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
Detailed Description
The sulfur-containing amino acid methionine and its downstream metabolite cysteine has been associated with fat mass in animal studies and human observational studies. Some of the proposed mechanisms include an association with lipogenesis, insulin sensitivity and disrupted energy metabolism. The overall aim of this project is to evaluate the effects of a diet low in methionine and cysteine on markers of lipids, amino acids, glucose and other biomarkers related to energy metabolism, including transcriptomic and protein expression data from adipose tissue and lymphocytes. Overweight and obese but otherwise healthy volunteers will be randomized to receive a diet either low, moderate or high in methionine and cysteine concentrations for 1 week. This is a pilot study that may be considered an extension of NCT02647970. In addition to the primary and secondary outcomes we will evaluate the feasibility of the intervention and procedures.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight
Keywords
Methionine, Cysteine, Energy metabolism, Sulfur amino acids

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
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.
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low met/cys diet
Arm Type
Experimental
Arm Description
Dietary intervention
Arm Title
Moderate met/cys diet
Arm Type
Experimental
Arm Description
Dietary intervention
Arm Title
High met/cys diet
Arm Type
Active Comparator
Arm Description
Dietary intervention
Intervention Type
Behavioral
Intervention Name(s)
Low met/cys diet
Intervention Description
Dietary intervention with low contents of methionine and cysteine
Intervention Type
Behavioral
Intervention Name(s)
Moderate met/cys diet
Intervention Description
Dietary intervention with moderate contents of methionine and cysteine
Intervention Type
Behavioral
Intervention Name(s)
High met/cys diet
Intervention Description
Dietary intervention with high contents of methionine and cysteine
Primary Outcome Measure Information:
Title
Change in plasma concentrations of amino acids
Description
Measurement of biomarkers of amino acid metabolism, including plasma concentrations of methionine, cysteine and related metabolites
Time Frame
Baseline, Day 1, Day 3 and Day 7 (final visit)
Title
Change in protein expression activity in tissues
Description
Measurement of protein expression and activity related to methionine and cysteine metabolism in adipose tissue and lymphocytes.
Time Frame
Baseline and day 7 (final visit for adipose tissue, Baseline and day 1, 3 and 7 (final visit) for lymphocytes.
Secondary Outcome Measure Information:
Title
Change in plasma concentrations of fatty acids
Description
Measurement of fatty acid content in plasma
Time Frame
Baseline, Day 1, Day 3 and Day 7 (final visit)
Title
Change in plasma activity indices of steaoryl-CoA desaturase
Description
Calculated based onthe ratio of plasma concentrations of products and precursors
Time Frame
Baseline, Day 1, Day 3 and Day 7 (final visit)
Title
Change in protein expression of steaoryl CoA-desaturase in adipose tissue
Description
Measurement of protein expression of steaoryl CoA-desaturase in adipose tissue
Time Frame
Baseline and Day 7 (final visit)
Title
Change in protein expression of steaoryl CoA-desaturase in lymphocytes
Description
Measurement of protein expression of steaoryl CoA-desaturase in lymphocytes
Time Frame
Baseline, Day 1, Day 3 and Day 7 (final visit)
Title
Change in steaoryl CoA-desaturase activity in adipose tissue
Description
Measurement of enzyme activity of steaoryl CoA-desaturase in adipose tissue
Time Frame
Baseline and Day 7 (final visit)
Title
Diet feasibility
Description
Diet feasibility will be measured by a self-administered questionnaire
Time Frame
Baseline, Day 1, Day 3 and Day 7 (final visit)
Title
Diet compliance
Description
Compliance with the diet will be measured by a self-administered questionnaire
Time Frame
Baseline, Day 1, Day 3 and Day 7 (final visit)
Title
Body composition
Description
Measurement of body composition by bioimpedance and dual X-ray absorptometry
Time Frame
Baseline and day 7 (final visit)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Body mass index of 25-35 kg/m2 Exclusion Criteria: High physical activity Smoking Drugs Chronic disease Pregnancy or breastfeeding
Facility Information:
Facility Name
University of Oslo
City
Oslo
ZIP/Postal Code
0372
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
32160926
Citation
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.
Results Reference
result

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Methionine and Cysteine Restriction in Humans

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