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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05455164
Enrollment
13
Registered
2022-07-13
Start date
2020-01-01
Completion date
2022-06-01
Last updated
2022-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dietary Exposure

Keywords

isomalto-oligosaccharide, blood glucose, cholesterol, fibre diet

Brief summary

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

Detailed description

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.

Interventions

DIETARY_SUPPLEMENTIsomalto Oligosaccharide

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)

Sponsors

Universitas Katolik Widya Mandala Surabaya
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

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. 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

* (BMI) of \>= 25.0 * Healthy subjects

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Plasma Uric Acid2 weeks after mealPlasma Uric Acid mg/dl
Total Cholesterol2 weeks after mealTotal Cholesterol Mg/dl
body composition analysis (Arm-, Trunk-, Leg Fat composition)2 weeks after mealin Kg or %
Fasting Plasma Glucose2 weeks after mealFasting Plasma Glucose mmol/dl

Countries

Indonesia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026