NCT06210230

Brief Summary

Double-blind and placebo-controlled study on intervention effect of medium and long chain fatty acid triglyceride on glycolipid homeostasis in patients with metabolic syndrome and mechanisms

Trial Health

87
On Track

Trial Health Score

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

Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2023

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

May 22, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 22, 2023

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2023

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

January 6, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 18, 2024

Completed
Last Updated

March 18, 2024

Status Verified

May 1, 2023

Enrollment Period

6 months

First QC Date

January 6, 2024

Last Update Submit

March 14, 2024

Conditions

Metabolic Syndrome

Keywords

metabolic syndromeMLCT

Outcome Measures

Primary Outcomes (2)

  • Change in blood glucose from baseline

    The investigators will measure HbA1c and fasting plasma glucose levels in blood samples before and after treatment.

    6 months

  • Change in blood lipids from baseline

    The investigators will measure Triglycerides (TG), total cholesterol (TC), LDL-C, and HDL-C levels in blood samples before and after treatment.

    6 months

Study Arms (2)

Control group

PLACEBO COMPARATOR
Dietary Supplement: Olive oil

Intervention group

EXPERIMENTAL
Dietary Supplement: MLCT supplementation

Interventions

MLCT supplementationDIETARY_SUPPLEMENT

MLCT 25g/d for 6 months

Intervention group
Olive oilDIETARY_SUPPLEMENT

Matching placebo (olive oil) 25g/d for 6 months

Control group

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed metabolic syndrome according to IDF diagnostic criteria;
  • Rarely eating out of home;
  • Aged between 40 and 70 years.

You may not qualify if:

  • Breastfeeding or pregnancy;
  • History of heart disease, coronary heart disease, stroke, cerebral infarction, viral liver disease (hepatitis A, hepatitis B, etc.), chronic kidney disease (GFR\<60 ml/min) or cancer;
  • Diabetic ketoacidosis or hyperketosis;
  • Drug use has changed in the past six months;
  • Taking insulin;
  • Used MLCT edible oil in the past six months;
  • Have participated in other clinical trials in the last three months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lanxi Traditional Chinese Medicine Hospital

Jinhua, Zhejiang, 321102, China

Location

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

Olive Oil

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Dietary Fats, UnsaturatedDietary FatsFatsLipidsFats, UnsaturatedPlant OilsOilsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 6, 2024

First Posted

January 18, 2024

Study Start

May 22, 2023

Primary Completion

November 22, 2023

Study Completion

December 10, 2023

Last Updated

March 18, 2024

Record last verified: 2023-05

Locations

CN(1)