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

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

Study Overview

• Status: Completed
• Conditions: Dietary Exposure
• Intervention / Treatment: Dietary supplement: Isomalto Oligosaccharide

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 Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Indonesia
  • Jawa Timur
    • Surabaya, Jawa Timur, Indonesia, 60112
      • Universitas Katolik Widya Mandala Surabaya

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• (BMI) of >= 25.0
• Healthy subjects

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

OTHER: Without supplementation, followed by Supplementation with Dietary Fibre; 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

Dietary supplement: Isomalto 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)

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Universitas Katolik Widya Mandala Surabaya
• Investigators: Principal Investigator: Hendy Wijaya, MD.M.Biomed., Faculty of Pharmacy, Universitas Katolik Widya Mandala Surabaya

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2020
• Primary Completion (ACTUAL): January 1, 2022
• Study Completion (ACTUAL): June 1, 2022

Study Registration Dates

• First Submitted: July 5, 2022
• First Submitted That Met QC Criteria: July 8, 2022
• First Posted (ACTUAL): July 13, 2022

Study Record Updates

• Last Update Posted (ACTUAL): July 13, 2022
• Last Update Submitted That Met QC Criteria: July 8, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: blood glucose; cholesterol; isomalto-oligosaccharide; fibre diet
• Other Study ID Numbers: 0295/WM12/KEPK/DSN/T/2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No