Food Replacement on Weight Control in Overweight Volunteers

NCT ID: NCT06488339

Last Updated: 2024-07-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-15

Study Completion Date

2025-05-15

Brief Summary

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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.

Detailed Description

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Conditions

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Weight Gain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Protein and oil supplement

Take 1 sachet/day replaced dinner

Group Type EXPERIMENTAL

Protein and oil supplement

Intervention Type DIETARY_SUPPLEMENT

Take 1 sachet/day replaced dinner

Normal dietary meal

Take normal dietary meal for dinner

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Protein and oil supplement

Take 1 sachet/day replaced dinner

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mae Fah Luang University

OTHER

Sponsor Role collaborator

Chulalongkorn University

OTHER

Sponsor Role lead

Responsible Party

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Pornanong Aramwit, Pharm.D., Ph.D

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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EC23238-20

Identifier Type: -

Identifier Source: org_study_id

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