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

NCT05455164 | Completed DMC

• 1 other identifier: 0295/WM12/KEPK/DSN/T/2022
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dietary Exposure

Keywords

isomalto-oligosaccharide; blood glucose; cholesterol; fibre diet

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

Without supplementation, followed by Supplementation with Dietary Fibre

OTHER

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

Interventions

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)

Without supplementation, followed by Supplementation with Dietary Fibre

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Universitas Katolik Widya Mandala Surabaya: lead

Study Sites (1)

Universitas Katolik Widya Mandala Surabaya

Surabaya, East Java, 60112, Indonesia

Location

Study Officials

• Hendy Wijaya, MD.M.Biomed.

  Faculty of Pharmacy, Universitas Katolik Widya Mandala Surabaya

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Clinical Pharmacology research laboratories

Model Details: 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.

Study Record Dates

• First Submitted: July 5, 2022
• First Posted: July 13, 2022
• Study Start: January 1, 2020
• Primary Completion: January 1, 2022
• Study Completion: June 1, 2022
• Last Updated: July 13, 2022

Record last verified: 2022-07

Locations

ID (1)