Skip to main content
OpenTrials
Completed

NCT Number: NCT05455164

The Effect of Eucaloric High-Protein Fiber Diet in Healthy Adults: A Repeated Single-Arm Clinical Trial

The aims of this study is to investigate the effect of eucaloric high protein and fiber diet on healthy subjects.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Dietary Exposure

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitas Katolik Widya Mandala Surabaya

Surabaya, East Java, 60112, Indonesia

About this study

Several studies have shown that high protein diet can reduce body fat, increase muscle mass, and improve some metabolic parameters of subjects. Also, several studies have shown that high intake of fiber could reduce body weight and improve cardiometabolic parameters. Therefore, combining high-protein diet and high-fiber diet should have a positive synergistic effect on several of anthropometric and metabolic parameters. The aims of this study is to investigate the effect of eucaloric high protein and fiber diet on healthy subjects. Thirteen healthy subjects, age 29,85 ± 4,06 years old, with body mass index (BMI) 29,55 ± 4,12 kg/m2 were prescribed eucaloric high protein diet for two weeks, followed by washing period for two week. Then, they were prescribed with eucaloric high protein and high fiber diet for two more weeks. Twenty grams of dietary fiber were in the form of isomaltooligosaccharides (IMO) based creamer formulae. Their body composition, waist circumference, fasting blood glucose, blood uric acid and total cholesterol concentration were measured after every dietary intervention.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • (BMI) of >= 25.0
  • Healthy subjects

Exclusion criteria

  • pregnant,
  • under any medication
  • having any kind of diseases and acute infection

Treatment and study plan

Isomalto Oligosaccharide

Dietary Supplement

all of the subjects were given eucaloric prepared meal which contain high protein and DF (contain 25-30 gram DF and protein content between 30-40% of total macronutrient distribution range)

Primary outcomes

  1. body composition analysis (Arm-, Trunk-, Leg Fat composition)

    Time frame: 2 weeks after meal

    in Kg or %

  2. Fasting Plasma Glucose

    Time frame: 2 weeks after meal

    Fasting Plasma Glucose mmol/dl

  3. Plasma Uric Acid

    Time frame: 2 weeks after meal

    Plasma Uric Acid mg/dl

  4. Total Cholesterol

    Time frame: 2 weeks after meal

    Total Cholesterol Mg/dl

Sponsors and collaborators

Lead sponsor

Universitas Katolik Widya Mandala Surabaya

Other

Registry information

Official study title

The Effect of Eucaloric High-Protein Fiber Diet on Anthropometric and Metabolic Profile of Healthy Adults: A Repeated Single-Arm Clinical Trial

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jul 13, 2022
Registry last updated
Jul 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.