Food Replacement on Weight Control in Overweight Volunteers

June 28, 2024 updated by: Pornanong Aramwit, Pharm.D., Ph.D, Chulalongkorn University

Efficacy and Safety of Food Replacement on Weight Control in Overweight Volunteers

Volunteers will be divided into two groups which are protein and oil supplement group and normal dietary group. For protein and oil supplement group, they will take 1 sachet of product replaced dinner every day for 8 weeks. For normal dietary group, they will take regular dinner every day for 8 weeks. Weight, body mass index, body composition, waist and hip circumference, skin fold thickness, and chemistry in blood will be evaluated.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age 18-60 years
  • Body mass index more than 23 kg/m2
  • No heart disease, diabetes mellitus, thyroid disease, cancer, liver and kidney diseases
  • Wiling to attend the study

Exclusion Criteria:

  • Allergic to protein, grains, guar gum
  • Take medicine, supplement, herbal substance for weight control within 1 month
  • During intermittent fasting
  • Take birth control pill, steroids, anti-depressant drugs, and anti-epilepsy drugs
  • Cushing syndrome's
  • Pregnancy and lactation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Protein and oil supplement
Take 1 sachet/day replaced dinner
Dietary supplement: Protein and oil supplement
Take 1 sachet/day replaced dinner
No Intervention: Normal dietary meal
Take normal dietary meal for dinner

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight
Time Frame: 8 weeks
Weight of volunteers (kg)
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body mass index
Time Frame: 8 weeks
Body mass index of volunteers (kg/m2)
8 weeks
Percentage of body fat
Time Frame: 8 weeks
Percentage of body fat (%) using bioelectrical impedance analysis (BIA)
8 weeks
Percentage of visceral fat
Time Frame: 8 weeks
Percentage of visceral fat (%) using bioelectrical impedance analysis (BIA)
8 weeks
Percentage of subcutaneous fat
Time Frame: 8 weeks
Percentage of subcutaneous fat (%) using bioelectrical impedance analysis (BIA)
8 weeks
Percentage of muscle
Time Frame: 8 weeks
Percentage of muscle (%) using bioelectrical impedance analysis (BIA)
8 weeks
Waist Circumference
Time Frame: 8 weeks
Waist Circumference (cm)
8 weeks
Hip Circumference
Time Frame: 8 weeks
Hip Circumference (cm)
8 weeks
Skin fold thickness
Time Frame: 8 weeks
Skin fold thickness (mm) using Skinfold Caliper
8 weeks
Total cholesterol
Time Frame: 8 weeks
Blood total cholesterol (mg/dL)
8 weeks
Low density lipoprotein
Time Frame: 8 weeks
Low density lipoprotein (mg/dL) in blood
8 weeks
High density lipoprotein
Time Frame: 8 weeks
High density lipoprotein (mg/dL) in blood
8 weeks
Triglycerides
Time Frame: 8 weeks
Triglycerides (mg/dL) in blood
8 weeks
Fasting blood sugar
Time Frame: 8 weeks
Fasting blood sugar (mg/dL) in blood
8 weeks
Hemoglobin A1C
Time Frame: 8 weeks
Hemoglobin A1C (%) in blood
8 weeks
Total protein
Time Frame: 8 weeks
Total protein (g/dL) in blood
8 weeks
Hemoglobin
Time Frame: 8 weeks
Hemoglobin (g/dL) in blood
8 weeks
SIRT1 (NAD-dependent deacetylase sirtuin-1)
Time Frame: 8 weeks
SIRT1 (NAD-dependent deacetylase sirtuin-1) (%) in blood
8 weeks
8-hydroxy-2-deoxyguanosine
Time Frame: 8 weeks
8-hydroxy-2-deoxyguanosine (%) in blood
8 weeks
Blood urea nitrogen
Time Frame: 8 weeks
Blood urea nitrogen (mg/dL) in blood
8 weeks
Creatinine
Time Frame: 8 weeks
Creatinine (mg/dL) in blood
8 weeks
Aspartate transaminase
Time Frame: 8 weeks
Aspartate transaminase (U/L) in blood
8 weeks
Alanine aminotransferase
Time Frame: 8 weeks
Alanine aminotransferase (U/L) in blood
8 weeks
Alkaline phosphatase
Time Frame: 8 weeks
Alkaline phosphatase (U/L) in blood
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chulalongkorn University

Collaborators

Mae Fah Luang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 15, 2024

Primary Completion (Estimated)

April 30, 2025

Study Completion (Estimated)

May 15, 2025

Study Registration Dates

First Submitted

June 28, 2024

First Submitted That Met QC Criteria

June 28, 2024

First Posted (Actual)

July 5, 2024

Study Record Updates

Last Update Posted (Actual)

July 5, 2024

Last Update Submitted That Met QC Criteria

June 28, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EC23238-20

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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