Clinical trial NCT03629392: Methionine and Cysteine Restriction in Humans
Official title: Dietary Methionine and Cysteine Restriction in Overweight Human Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Keywords: Methionine
Cysteine
Energy metabolism
Sulfur amino acids
Lead sponsor: University of Oslo
Sponsor class: OTHER
Collaborators: name: The Research Council of Norway
name: University of Oxford
First posted: 2018-08-14
Enrollment: 19
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: Inclusion Criteria:

* Body mass index of 25-35 kg/m2

Exclusion Criteria:

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

Primary outcomes:
measure: Change in plasma concentrations of amino acids
timeFrame: Baseline, Day 1, Day 3 and Day 7 (final visit)
measure: Change in protein expression activity in tissues
timeFrame: Baseline and day 7 (final visit for adipose tissue, Baseline and day 1, 3 and 7 (final visit) for lymphocytes.
Secondary outcomes:
measure: Change in plasma concentrations of fatty acids
timeFrame: Baseline, Day 1, Day 3 and Day 7 (final visit)
measure: Change in plasma activity indices of steaoryl-CoA desaturase
timeFrame: Baseline, Day 1, Day 3 and Day 7 (final visit)
measure: Change in protein expression of steaoryl CoA-desaturase in adipose tissue
timeFrame: Baseline and Day 7 (final visit)
measure: Change in protein expression of steaoryl CoA-desaturase in lymphocytes
timeFrame: Baseline, Day 1, Day 3 and Day 7 (final visit)
measure: Change in steaoryl CoA-desaturase activity in adipose tissue
timeFrame: Baseline and Day 7 (final visit)
measure: Diet feasibility
timeFrame: Baseline, Day 1, Day 3 and Day 7 (final visit)
measure: Diet compliance
timeFrame: Baseline, Day 1, Day 3 and Day 7 (final visit)
measure: Body composition
timeFrame: Baseline and day 7 (final visit)
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: University of Oslo
Study officials:
References:
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.