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

Not Applicable

Completed

• Conditions: Dietary Exposure
• Interventions: Dietary Supplement: Isomalto Oligosaccharide

• Registration Number: NCT05455164
• Lead Sponsor: Universitas Katolik Widya Mandala Surabaya

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.

Study Timeline

• Study Start: 2020-01-01
• Primary Completion: 2022-01-01
• Study Completion: 2022-06-01
• Status Verified: 2022-07
• Study First Submitted: 2022-07-05
• Study First Submitted QC: 2022-07-08
• Last Update Submitted: 2022-07-08
• Study First Posted: 2022-07-13
• Last Update Posted: 2022-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

• (BMI) of >= 25.0
• Healthy subjects

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Without supplementation, followed by Supplementation with Dietary Fibre	Isomalto Oligosaccharide	For the first two weeks, subjects were given eucaloric prepared meals typical of Indonesian diet, which has low protein and low DF contents (contain less than 15 g/d of DF and protein content less than 15% of total macronutrient distribution range). After two weeks of washing periods, 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). At the end of interventions, waist circumference, body weight, body composition, fasting plasma glucose, uric acid, and total cholesterol were measured again. Half of DF content in food came from natural occurring fiber from fruit, vegetables and whole grains, the other half (50%) come from IMO-based fiber supplement (FibercremeⓇ, PT. Lautan Natural Krimerindo, Mojokerto, Indonesia

Primary Outcome Measures

Name	Time	Method
Fasting Plasma Glucose	2 weeks after meal	Fasting Plasma Glucose mmol/dl
body composition analysis (Arm-, Trunk-, Leg Fat composition)	2 weeks after meal	in Kg or %
Plasma Uric Acid	2 weeks after meal	Plasma Uric Acid mg/dl
Total Cholesterol	2 weeks after meal	Total Cholesterol Mg/dl

Trial Locations

Locations (1)

Universitas Katolik Widya Mandala Surabaya; 🇮🇩 Surabaya, Jawa Timur, Indonesia