Clinical trial NCT03135132: The Effect of Mild Weight Loss on Circulating Metabolite Profiles
Official title: Metabolomics Identifies Increases in Acylcarnitine Profiles in Plasma of Overweight Subjects in Response to Mild Weight Loss
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Visceral Fat
Weight Loss
Keywords: High visceral fat
Low calorie diet
Mild weight loss
Metabolomics
Metabolites
Acylcarnitines
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2017-05-01
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: To determine whether low calorie diet (LCD)-induced weight reduction caused changes in plasma metabolites and metabolic traits from baseline.

Detailed description: Over a 12-week clinical intervention period, a randomized, controlled study was carried out; overweight subjects consumed a LCD (approximately 300kcal/d deficit, n=47) or a weight-maintenance diet (control, n=50) were included for analyzing plasma samples and metabolites using an ultra-performance liquid chromatography and mass spectrometry (UPLC-LTQ/Orbitrap MS).

Eligibility criteria: Inclusion Criteria:

* Able to give informed consent
* 20-65 years old
* Males and females
* Overweight (25.0 kg/m²≤ Body mass index \<30 kg/m²)
* Nondiabetic (Fasting glucose \<126 mg/dL)

Exclusion Criteria:

* Unstable body weight (body weight change \>1 kg within 3 months before screening)
* Consumption of medication that affects body weight or energy expenditure
* Pregnancy or breast-feeding
* Hypertension, type 2 diabetes, cardiovascular disease, cerebrovascular disease, or thyroid disease
* Liver disease, kidney disease, or gastrointestinal disease
* Acute or chronic infections
* Any acute or chronic disease requiring treatment

Primary outcomes:
measure: Visceral fat area at L4 (CT)
timeFrame: At baseline
measure: Visceral fat area at L4 (CT)
timeFrame: At 12-week follow-up
measure: Change in visceral fat area at L4 from baseline
timeFrame: At baseline and 12-week follow-up
measure: Putatively identified plasma metabolites (Normalized peak intensities)
timeFrame: At baseline
measure: Putatively identified plasma metabolites (Normalized peak intensities)
timeFrame: At 12-week follow-up
measure: Changes in putatively identified plasma metabolites (Normalized peak intensities) from baseline
timeFrame: At baseline and 12-week follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University
Study officials:
affiliation: Yonsei University
name: Jong Ho Lee, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jang HY, Han Y, Yoo HJ, Lee JH, Kim M. Effects of short-term dietary restriction on plasma metabolites and the subcutaneous fat area according to metabolic status in obese individuals: a case-control study. Diabetol Metab Syndr. 2021 Jun 7;13(1):62. doi: 10.1186/s13098-021-00679-8.
citation: Kang M, Yoo HJ, Kim M, Kim M, Lee JH. Metabolomics identifies increases in the acylcarnitine profiles in the plasma of overweight subjects in response to mild weight loss: a randomized, controlled design study. Lipids Health Dis. 2018 Oct 15;17(1):237. doi: 10.1186/s12944-018-0887-1.