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Completed

NCT Number: NCT03629392

Methionine and Cysteine Restriction in Humans

The aim of this study is to examine the effect of methionine and cysteine restriction on energy and macronutrient metabolism in overweight human subjects

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Key information

Conditions

Overweight Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Oslo

Oslo, 0372, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Body mass index of 25-35 kg/m2

Exclusion criteria

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

Treatment and study plan

Low met/cys diet

Behavioral

Dietary intervention with low contents of methionine and cysteine

Moderate met/cys diet

Behavioral

Dietary intervention with moderate contents of methionine and cysteine

High met/cys diet

Behavioral

Dietary intervention with high contents of methionine and cysteine

Primary outcomes

  1. Change in plasma concentrations of amino acids

    Time frame: Baseline, 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

  2. Change in protein expression activity in tissues

    Time frame: Baseline 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 outcomes

  1. Change in plasma concentrations of fatty acids

    Time frame: Baseline, Day 1, Day 3 and Day 7 (final visit)

    Measurement of fatty acid content in plasma

  2. Change in plasma activity indices of steaoryl-CoA desaturase

    Time frame: Baseline, Day 1, Day 3 and Day 7 (final visit)

    Calculated based onthe ratio of plasma concentrations of products and precursors

  3. Change in protein expression of steaoryl CoA-desaturase in adipose tissue

    Time frame: Baseline and Day 7 (final visit)

    Measurement of protein expression of steaoryl CoA-desaturase in adipose tissue

  4. Change in protein expression of steaoryl CoA-desaturase in lymphocytes

    Time frame: Baseline, Day 1, Day 3 and Day 7 (final visit)

    Measurement of protein expression of steaoryl CoA-desaturase in lymphocytes

  5. Change in steaoryl CoA-desaturase activity in adipose tissue

    Time frame: Baseline and Day 7 (final visit)

    Measurement of enzyme activity of steaoryl CoA-desaturase in adipose tissue

  6. Diet feasibility

    Time frame: Baseline, Day 1, Day 3 and Day 7 (final visit)

    Diet feasibility will be measured by a self-administered questionnaire

  7. Diet compliance

    Time frame: Baseline, Day 1, Day 3 and Day 7 (final visit)

    Compliance with the diet will be measured by a self-administered questionnaire

  8. Body composition

    Time frame: Baseline and day 7 (final visit)

    Measurement of body composition by bioimpedance and dual X-ray absorptometry

Sponsors and collaborators

Lead sponsor

University of Oslo

Other

Collaborators

  • The Research Council of Norway
  • University of Oxford

Registry information

Official study title

Dietary Methionine and Cysteine Restriction in Overweight Human Subjects

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Aug 14, 2018
Registry last updated
Mar 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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