Methionine and Cysteine Restriction in Humans

NCT ID: NCT03629392

Last Updated: 2020-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-08

Study Completion Date

2018-12-11

Brief Summary

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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

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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.

Conditions

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Overweight

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators
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.

Study Groups

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Low met/cys diet

Dietary intervention

Group Type EXPERIMENTAL

Low met/cys diet

Intervention Type BEHAVIORAL

Dietary intervention with low contents of methionine and cysteine

Moderate met/cys diet

Dietary intervention

Group Type EXPERIMENTAL

Moderate met/cys diet

Intervention Type BEHAVIORAL

Dietary intervention with moderate contents of methionine and cysteine

High met/cys diet

Dietary intervention

Group Type ACTIVE_COMPARATOR

High met/cys diet

Intervention Type BEHAVIORAL

Dietary intervention with high contents of methionine and cysteine

Interventions

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Low met/cys diet

Dietary intervention with low contents of methionine and cysteine

Intervention Type BEHAVIORAL

Moderate met/cys diet

Dietary intervention with moderate contents of methionine and cysteine

Intervention Type BEHAVIORAL

High met/cys diet

Dietary intervention with high contents of methionine and cysteine

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Body mass index of 25-35 kg/m2

Exclusion Criteria

* High physical activity
* Smoking
* Drugs
* Chronic disease
* Pregnancy or breastfeeding
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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The Research Council of Norway

OTHER

Sponsor Role collaborator

University of Oxford

OTHER

Sponsor Role collaborator

University of Oslo

OTHER

Sponsor Role lead

Responsible Party

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Kathrine Vinknes

Kathrine Vinknes, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Oslo

Oslo, , Norway

Site Status

Countries

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Norway

References

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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.

Reference Type RESULT
PMID: 32160926 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36542145 (View on PubMed)

Other Identifiers

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239948-B

Identifier Type: -

Identifier Source: org_study_id

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