Stearoyl-CoA Desaturase and Energy Metabolism in Humans

Not Applicable

Completed

• Conditions: Obesity; Healthy
• Interventions: Behavioral: SFA+Cys/Met diet; Behavioral: PUFA-Cys/Met diet

• Registration Number: NCT02647970
• Lead Sponsor: University of Oslo

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2015-12-04
• Study First Submitted QC: 2016-01-04
• Study First Posted: 2016-01-06
• Study Start: 2016-02
• Primary Completion: 2016-11
• Study Completion: 2016-11
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-17
• Last Update Posted: 2018-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B	SFA+Cys/Met diet	Dietary intervention
Group A	PUFA-Cys/Met diet	Dietary intervention

Primary Outcome Measures

Name	Time	Method
Change in metabolic biomarkers	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 Outcome Measures

Name	Time	Method
Change in biomarkers of glucose metabolism	Baseline and up to 7 days	Measurements of blood parameters including glucose and insulin, and Oral Glucose Tolerance Test
Change in molecular signatures	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
Appetite assessed by visual analogue scales	0, 15, 30, 45, 60, 90, 120, 180 minutes postprandially (single meal intervention). Change from baseline up to 7 days (7 days intervention)
Change in inflammatory markers	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.
Feasibility and compliance of the diet intervention	Up to 7 days	Evaluated by compliance questionnaires
Change in biomarkers of triglycerides metabolism	Baseline and up to 7 days	Measurements of blood parameters including LDL-/HDL-/VLDL-/total cholesterol, and triglycerides
Tolerance of the diet intervention	Up to 7 days	Assessed by blood pressure, pulse and laboratory parameters including haematology, clinical chemistry and urine analysis
Hunger and satiety patterns	Baseline and up to 7 days	Evaluated by plasma levels of hormones such as leptin, ghrelin, cholecystokinin, GLP-1 and PYY

Trial Locations

Locations (1)

University of Oslo; 🇳🇴 Oslo, Norway