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Methionine and Cysteine Restriction in Humans

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03629392
Recruitment Status : Completed
First Posted : August 14, 2018
Last Update Posted : March 25, 2020
Sponsor:
Collaborators:
The Research Council of Norway
University of Oxford
Information provided by (Responsible Party):
Kathrine Vinknes, University of Oslo

Study Description
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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

Condition or disease Intervention/treatment Phase
Overweight Behavioral: Low met/cys diet Behavioral: Moderate met/cys diet Behavioral: High met/cys diet Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
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.
Primary Purpose: Basic Science
Official Title: Dietary Methionine and Cysteine Restriction in Overweight Human Subjects
Actual Study Start Date : October 8, 2018
Actual Primary Completion Date : December 11, 2018
Actual Study Completion Date : December 11, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Low met/cys diet
Dietary intervention
 Behavioral: Low met/cys diet
Dietary intervention with low contents of methionine and cysteine
Experimental: Moderate met/cys diet
Dietary intervention
 Behavioral: Moderate met/cys diet
Dietary intervention with moderate contents of methionine and cysteine
Active Comparator: High met/cys diet
Dietary intervention
 Behavioral: High met/cys diet
Dietary intervention with high contents of methionine and cysteine


Outcome Measures
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Primary Outcome Measures :
  1. Change in plasma concentrations of amino acids [ Time Frame: Baseline, Day 1, Day 3 and Day 7 (final visit) ]
    Measurement of biomarkers of amino acid metabolism, including plasma concentrations of methionine, cysteine and related metabolites

  2. Change in protein expression activity in tissues [ Time Frame: Baseline and day 7 (final visit for adipose tissue, Baseline and day 1, 3 and 7 (final visit) for lymphocytes. ]
    Measurement of protein expression and activity related to methionine and cysteine metabolism in adipose tissue and lymphocytes.


Secondary Outcome Measures :
  1. Change in plasma concentrations of fatty acids [ Time Frame: Baseline, Day 1, Day 3 and Day 7 (final visit) ]
    Measurement of fatty acid content in plasma

  2. Change in plasma activity indices of steaoryl-CoA desaturase [ Time Frame: Baseline, Day 1, Day 3 and Day 7 (final visit) ]
    Calculated based onthe ratio of plasma concentrations of products and precursors

  3. Change in protein expression of steaoryl CoA-desaturase in adipose tissue [ Time Frame: Baseline and Day 7 (final visit) ]
    Measurement of protein expression of steaoryl CoA-desaturase in adipose tissue

  4. Change in protein expression of steaoryl CoA-desaturase in lymphocytes [ Time Frame: Baseline, Day 1, Day 3 and Day 7 (final visit) ]
    Measurement of protein expression of steaoryl CoA-desaturase in lymphocytes

  5. Change in steaoryl CoA-desaturase activity in adipose tissue [ Time Frame: Baseline and Day 7 (final visit) ]
    Measurement of enzyme activity of steaoryl CoA-desaturase in adipose tissue

  6. Diet feasibility [ Time Frame: Baseline, Day 1, Day 3 and Day 7 (final visit) ]
    Diet feasibility will be measured by a self-administered questionnaire

  7. Diet compliance [ Time Frame: Baseline, Day 1, Day 3 and Day 7 (final visit) ]
    Compliance with the diet will be measured by a self-administered questionnaire

  8. Body composition [ Time Frame: Baseline and day 7 (final visit) ]
    Measurement of body composition by bioimpedance and dual X-ray absorptometry


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Body mass index of 25-35 kg/m2

Exclusion Criteria:

  • High physical activity
  • Smoking
  • Drugs
  • Chronic disease
  • Pregnancy or breastfeeding
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03629392


Locations
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Norway
University of Oslo
Oslo, Norway, 0372
Sponsors and Collaborators
University of Oslo
The Research Council of Norway
University of Oxford
More Information
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Publications of Results:

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Responsible Party: Kathrine Vinknes, Kathrine Vinknes, PhD, University of Oslo
ClinicalTrials.gov Identifier: NCT03629392    
Other Study ID Numbers: 239948-B
First Posted: August 14, 2018    Key Record Dates
Last Update Posted: March 25, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kathrine Vinknes, University of Oslo:
Methionine
Cysteine
Energy metabolism
Sulfur amino acids
Additional relevant MeSH terms:
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Overweight
Body Weight