NCT04024540

Brief Summary

This is a prospective, randomized, two-armed study to assess the efficacy and safety of isocaloric dietary restriction in the treatment of obese without diabetic for a period of 4 weeks.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
72

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Jul 2019

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

July 13, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 18, 2019

Completed
5 days until next milestone

Study Start

First participant enrolled

July 23, 2019

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

August 29, 2024

Status Verified

August 1, 2024

Enrollment Period

5.2 years

First QC Date

July 13, 2019

Last Update Submit

August 28, 2024

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

  • Body weight

    Change of body weight (kg) from baseline measured by study personnel.

    4 weeks

Secondary Outcomes (16)

  • Body mass index

    4 weeks

  • Waist, hip and neck circumference

    4 weeks

  • Body composition

    4 weeks

  • Liver fat content

    4 weeks

  • Energy expenditure

    4 weeks

  • +11 more secondary outcomes

Study Arms (2)

isocaloric dietary restriction

EXPERIMENTAL

Very low caloric diet 400 kcal/d for a week, 600 kcal/d for another week and 800 kcal/d for 2 weeks.

Dietary Supplement: isocaloric dietary restriction

Bariatric surgery

ACTIVE COMPARATOR

Laparoscopic vertical sleeve gastrectomy

Dietary Supplement: isocaloric dietary restrictionProcedure: Bariatric surgery

Interventions

isocaloric dietary restrictionDIETARY_SUPPLEMENT

Very low caloric diet

Bariatric surgeryisocaloric dietary restriction
Bariatric surgeryPROCEDURE

Laparoscopic vertical sleeve gastrectomy

Bariatric surgery

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age between 18 to 45 years old
  • ≤ BMI ≤ 45 kg/m2

You may not qualify if:

  • Obesity induced by other endocrinologic disorders
  • Severe gastrointestinal diseases or contraindication for surgery
  • History or newly known of diabetes
  • Use of hypoglycemic medications, antibiotic in the preceding 2 months, or yogurt within 5 days
  • Weight change more than 5% of body weight within the past 3 months
  • Severe or unstable cardiovascular, liver or renal diseases or known cancer
  • History of drug or alcohol abuse or other substance abuse
  • Any mental disorders or current use of antidepressantsPregnancy or lactation or consideration of pregnancy
  • Allergies to specific food ingredients in the intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ruijin hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Location

MeSH Terms

Conditions

Obesity

Interventions

Bariatric Surgery

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

BariatricsObesity ManagementTherapeuticsSurgical Procedures, Operative

Study Officials

  • Weiqing Wang, M.D. Ph.D.

    Shanghai Clinic Center for Endocrine and Metabolic Diseases, Ruijin Hospital, Shanghai Institute for Endocrine and Metabolic Diseases

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 13, 2019

First Posted

July 18, 2019

Study Start

July 23, 2019

Primary Completion

October 1, 2024

Study Completion

December 1, 2024

Last Updated

August 29, 2024

Record last verified: 2024-08

Locations

CN(1)