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Completed

NCT Number: NCT02647970

Stearoyl-CoA Desaturase and Energy Metabolism in Humans

The aim of this study is to examine if changing stearoyl-coenzyme A desaturase-1 (SCD1) activity through dietary interventions can increase energy metabolism in humans.

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Key information

Conditions

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

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Oslo

Oslo, Norway

About this study

In rodents as well as humans, high stearoyl-coenzyme A desaturase-1 (SCD1) activity is considered to be involved in development of obesity. In animal models, polyunsaturated fatty acids (PUFA) inhibit Scd1 gene expression and at the population level, dietary PUFA and plasma PUFA show strong inverse associations with plasma SCD indices. Emerging evidence also suggests a role for the sulphur amino acid cysteine in regulating SCD1 activity and obesity.

The overall aim of the project is to examine if interventions that lowers SCD1 activity lead to increased energy metabolism. In this project, the investigators will conduct dietary intervention trials to evaluate the effects of short-term consumption of a diet rich in polyunsaturated fatty acids (PUFA) and low in cysteine and its precursor methionine (PUFA-Cys/Met) vs. a diet rich in saturated fatty acids (SFA) and cysteine/methionine (SFA+Cys/Met) on SCD1 activity, lipids, amino acids, glucose and other biomarkers related to energy metabolism, in healthy normal-weight subjects. Healthy volunteers will be randomized to the PUFA-Cys/Met or SFA+Cys/Met diets receiving supplements/meals in a single dose or for 7 days.

This study is a pilot study, with main focus on feasibility, tolerance and side effects. If the pilot shows positive results in terms of side effects, safety and tolerance, the investigators will follow-up by including obese subjects in a longer dietary intervention.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy normal-weight (BMI 20-25 kg/m2)

Exclusion criteria

  • High physical activity
  • Smoking
  • High intake of fatty fish or cod liver oil
  • Drugs
  • Pregnancy or breastfeeding
  • Chronic disease

Treatment and study plan

PUFA-Cys/Met diet

Behavioral

Provision of food and supplements that are rich in polyunsaturated fatty acids (PUFA, n-3 and n-6) and low in the amino acids cysteine (Cys) and methionine (Met).

SFA+Cys/Met diet

Behavioral

Provision of food and supplements that are rich in saturated fatty acids (SFA) and the amino acids cysteine (Cys) and methionine (Met).

Primary outcomes

  1. Change in metabolic biomarkers

    Time frame: 0 hour and at 30 min, 1, 2, 3, 4, 6, 8, 12, 24, 48 and 72 h after single meal. Baseline and up to 7 days in 7 days intervention

    Measurement of biomarkers of amino acid and fatty acid metabolism, including plasma concentration of cysteine, methionine, fatty acids, and stearoyl CoA desaturase (SCD) indices

Secondary outcomes

  1. Change in biomarkers of glucose metabolism

    Time frame: Baseline and up to 7 days

    Measurements of blood parameters including glucose and insulin, and Oral Glucose Tolerance Test

  2. Change in biomarkers of triglycerides metabolism

    Time frame: Baseline and up to 7 days

    Measurements of blood parameters including LDL-/HDL-/VLDL-/total cholesterol, and triglycerides

  3. Change in molecular signatures

    Time frame: Baseline and up to 7 days

    Evaluation of markers related to lipid, amino acid and glucose metabolism, including measurements of mRNA expression in blood cells, and proteins and metabolites, in blood and/or urine

  4. Hunger and satiety patterns

    Time frame: Baseline and up to 7 days

    Evaluated by plasma levels of hormones such as leptin, ghrelin, cholecystokinin, GLP-1 and PYY

  5. Appetite assessed by visual analogue scales

    Time frame: 0, 15, 30, 45, 60, 90, 120, 180 minutes postprandially (single meal intervention). Change from baseline up to 7 days (7 days intervention)

  6. Change in inflammatory markers

    Time frame: Baseline and up to 7 days

    Measurements of blood parameters, e.g., CRP, cytokines and chemokines, adipokines, metabolic markers, hormones, growth factors, tissue remodeling proteins, angiogenesis markers, acute phase reactants, and other important circulating proteins.

  7. Feasibility and compliance of the diet intervention

    Time frame: Up to 7 days

    Evaluated by compliance questionnaires

  8. Tolerance of the diet intervention

    Time frame: Up to 7 days

    Assessed by blood pressure, pulse and laboratory parameters including haematology, clinical chemistry and urine analysis

Sponsors and collaborators

Lead sponsor

University of Oslo

Other

Collaborators

  • The Research Council of Norway
  • University of Oxford

Registry information

Acronym: SEM

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jan 6, 2016
Registry last updated
Sep 18, 2018

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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