NCT06488339

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2024

Shorter than P25 for not_applicable

Status
not yet 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

June 28, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 5, 2024

Completed
10 days until next milestone

Study Start

First participant enrolled

July 15, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2025

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2025

Completed
Last Updated

July 5, 2024

Status Verified

June 1, 2024

Enrollment Period

10 months

First QC Date

June 28, 2024

Last Update Submit

June 28, 2024

Conditions

Weight Gain

Outcome Measures

Primary Outcomes (1)

  • Weight

    Weight of volunteers (kg)

    8 weeks

Secondary Outcomes (23)

  • Body mass index

    8 weeks

  • Percentage of body fat

    8 weeks

  • Percentage of visceral fat

    8 weeks

  • Percentage of subcutaneous fat

    8 weeks

  • Percentage of muscle

    8 weeks

  • +18 more secondary outcomes

Study Arms (2)

Protein and oil supplement

EXPERIMENTAL

Take 1 sachet/day replaced dinner

Dietary Supplement: Protein and oil supplement

Normal dietary meal

NO INTERVENTION

Take normal dietary meal for dinner

Interventions

Protein and oil supplementDIETARY_SUPPLEMENT

Take 1 sachet/day replaced dinner

Protein and oil supplement

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Weight Gain

Interventions

Proteins

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and Proteins

Study Design

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

Study Record Dates

First Submitted

June 28, 2024

First Posted

July 5, 2024

Study Start

July 15, 2024

Primary Completion

April 30, 2025

Study Completion

May 15, 2025

Last Updated

July 5, 2024

Record last verified: 2024-06