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Methionine and Cysteine Restriction in Humans

Dietary Methionine and Cysteine Restriction in Overweight Human Subjects

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03629392
Enrollment
19
Registered
2018-08-14
Start date
2018-10-08
Completion date
2018-12-11
Last updated
2020-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overweight

Keywords

Methionine, Cysteine, Energy metabolism, Sulfur amino acids

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.

Interventions

BEHAVIORALLow met/cys diet

Dietary intervention with low contents of methionine and cysteine

BEHAVIORALModerate met/cys diet

Dietary intervention with moderate contents of methionine and cysteine

BEHAVIORALHigh met/cys diet

Dietary intervention with high contents of methionine and cysteine

Sponsors

The Research Council of Norway
CollaboratorOTHER
University of Oxford
CollaboratorOTHER
University of Oslo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, 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.

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

* Body mass index of 25-35 kg/m2

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Change in plasma concentrations of amino acidsBaseline, 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
Change in protein expression activity in tissuesBaseline 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

MeasureTime frameDescription
Change in protein expression of steaoryl CoA-desaturase in adipose tissueBaseline and Day 7 (final visit)Measurement of protein expression of steaoryl CoA-desaturase in adipose tissue
Change in protein expression of steaoryl CoA-desaturase in lymphocytesBaseline, Day 1, Day 3 and Day 7 (final visit)Measurement of protein expression of steaoryl CoA-desaturase in lymphocytes
Change in steaoryl CoA-desaturase activity in adipose tissueBaseline and Day 7 (final visit)Measurement of enzyme activity of steaoryl CoA-desaturase in adipose tissue
Change in plasma concentrations of fatty acidsBaseline, Day 1, Day 3 and Day 7 (final visit)Measurement of fatty acid content in plasma
Diet complianceBaseline, Day 1, Day 3 and Day 7 (final visit)Compliance with the diet will be measured by a self-administered questionnaire
Body compositionBaseline and day 7 (final visit)Measurement of body composition by bioimpedance and dual X-ray absorptometry
Diet feasibilityBaseline, Day 1, Day 3 and Day 7 (final visit)Diet feasibility will be measured by a self-administered questionnaire
Change in plasma activity indices of steaoryl-CoA desaturaseBaseline, Day 1, Day 3 and Day 7 (final visit)Calculated based onthe ratio of plasma concentrations of products and precursors

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026