Viewing Study NCT03629392


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Study NCT ID: NCT03629392
Status: COMPLETED
Last Update Posted: 2020-03-25
First Post: 2018-08-02
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Methionine and Cysteine Restriction in Humans
Sponsor: University of Oslo
Organization:

Study Overview

Official Title: Dietary Methionine and Cysteine Restriction in Overweight Human Subjects
Status: COMPLETED
Status Verified Date: 2020-03
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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.

Study Oversight

Has Oversight DMC: True
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: