NCT02647970

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Feb 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 4, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 6, 2016

Completed
26 days until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

September 18, 2018

Status Verified

September 1, 2018

Enrollment Period

9 months

First QC Date

December 4, 2015

Last Update Submit

September 17, 2018

Conditions

HealthyObesity

Keywords

Energy metabolism

Outcome Measures

Primary Outcomes (1)

  • Change in metabolic biomarkers

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

    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

Secondary Outcomes (8)

  • Change in biomarkers of glucose metabolism

    Baseline and up to 7 days

  • Change in biomarkers of triglycerides metabolism

    Baseline and up to 7 days

  • Change in molecular signatures

    Baseline and up to 7 days

  • Hunger and satiety patterns

    Baseline and up to 7 days

  • 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)

  • +3 more secondary outcomes

Study Arms (2)

Group A

EXPERIMENTAL

Dietary intervention

Behavioral: PUFA-Cys/Met diet

Group B

ACTIVE COMPARATOR

Dietary intervention

Behavioral: SFA+Cys/Met diet

Interventions

PUFA-Cys/Met dietBEHAVIORAL

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).

Group A
SFA+Cys/Met dietBEHAVIORAL

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

Group B

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Oslo

Oslo, Norway

Location

Related Publications (3)

  • Elshorbagy A, Bastani NE, Lee-Odegard S, Ovrebo B, Haj-Yasein N, Svendsen K, Turner C, Refsum H, Vinknes KJ, Olsen T. The association of fasting plasma thiol fractions with body fat compartments, biomarker profile, and adipose tissue gene expression. Amino Acids. 2023 Mar;55(3):313-323. doi: 10.1007/s00726-022-03229-2. Epub 2022 Dec 21.

    PMID: 36542145DERIVED

  • Olsen T, Ovrebo B, Turner C, Bastani NE, Refsum H, Vinknes KJ. Effects of short-term methionine and cysteine restriction and enrichment with polyunsaturated fatty acids on oral glucose tolerance, plasma amino acids, fatty acids, lactate and pyruvate: results from a pilot study. BMC Res Notes. 2021 Feb 2;14(1):43. doi: 10.1186/s13104-021-05463-5.

    PMID: 33531059DERIVED

  • Olsen T, Turner C, Ovrebo B, Bastani NE, Refsum H, Vinknes KJ. Postprandial effects of a meal low in sulfur amino acids and high in polyunsaturated fatty acids compared to a meal high in sulfur amino acids and saturated fatty acids on stearoyl CoA-desaturase indices and plasma sulfur amino acids: a pilot study. BMC Res Notes. 2020 Aug 10;13(1):379. doi: 10.1186/s13104-020-05222-y.

    PMID: 32778150DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

December 4, 2015

First Posted

January 6, 2016

Study Start

February 1, 2016

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

September 18, 2018

Record last verified: 2018-09

Locations

NO(1)