Methionine and Cysteine Restriction in Humans

Overweight Clinical Trial

Official title:

Dietary Methionine and Cysteine Restriction in Overweight Human Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03629392
• Other study ID #: 239948-B
• Status: Completed
• Phase: N/A
• Start date: October 8, 2018
• Est. completion date: December 11, 2018

Study information

• Verified date: March 2020
• Source: University of Oslo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: December 11, 2018
• Est. primary completion date: December 11, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

• Body mass index of 25-35 kg/m2

Exclusion Criteria:

• High physical activity

• Smoking

• Drugs

• Chronic disease

• Pregnancy or breastfeeding

Related Conditions & MeSH terms

• Overweight

Intervention

Behavioral:
• Low met/cys diet
Dietary intervention with low contents of methionine and cysteine
• Moderate met/cys diet
Dietary intervention with moderate contents of methionine and cysteine
• High met/cys diet
Dietary intervention with high contents of methionine and cysteine

Locations

Country	Name	City	State
Norway	University of Oslo	Oslo

Sponsors (3)

Lead Sponsor	Collaborator
University of Oslo	The Research Council of Norway, University of Oxford

Country where clinical trial is conducted

Norway, 

References & Publications (1)

Olsen T, Øvrebø 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 e — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in plasma concentrations of amino acids	Measurement of biomarkers of amino acid metabolism, including plasma concentrations of methionine, cysteine and related metabolites	Baseline, Day 1, Day 3 and Day 7 (final visit)
Primary	Change in protein expression activity in tissues	Measurement of protein expression and activity related to methionine and cysteine metabolism in adipose tissue and lymphocytes.	Baseline and day 7 (final visit for adipose tissue, Baseline and day 1, 3 and 7 (final visit) for lymphocytes.
Secondary	Change in plasma concentrations of fatty acids	Measurement of fatty acid content in plasma	Baseline, Day 1, Day 3 and Day 7 (final visit)
Secondary	Change in plasma activity indices of steaoryl-CoA desaturase	Calculated based onthe ratio of plasma concentrations of products and precursors	Baseline, Day 1, Day 3 and Day 7 (final visit)
Secondary	Change in protein expression of steaoryl CoA-desaturase in adipose tissue	Measurement of protein expression of steaoryl CoA-desaturase in adipose tissue	Baseline and Day 7 (final visit)
Secondary	Change in protein expression of steaoryl CoA-desaturase in lymphocytes	Measurement of protein expression of steaoryl CoA-desaturase in lymphocytes	Baseline, Day 1, Day 3 and Day 7 (final visit)
Secondary	Change in steaoryl CoA-desaturase activity in adipose tissue	Measurement of enzyme activity of steaoryl CoA-desaturase in adipose tissue	Baseline and Day 7 (final visit)
Secondary	Diet feasibility	Diet feasibility will be measured by a self-administered questionnaire	Baseline, Day 1, Day 3 and Day 7 (final visit)
Secondary	Diet compliance	Compliance with the diet will be measured by a self-administered questionnaire	Baseline, Day 1, Day 3 and Day 7 (final visit)
Secondary	Body composition	Measurement of body composition by bioimpedance and dual X-ray absorptometry	Baseline and day 7 (final visit)