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

Dietary Exposure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05455164
• Other study ID #: 0295/WM12/KEPK/DSN/T/2022
• Status: Completed
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: June 1, 2022

Study information

• Verified date: July 2022
• Source: Universitas Katolik Widya Mandala Surabaya
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: June 1, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• (BMI) of >= 25.0
• Healthy subjects

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Dietary Exposure

Intervention

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)

Locations

Country	Name	City	State
Indonesia	Universitas Katolik Widya Mandala Surabaya	Surabaya	Jawa Timur

Sponsors (1)

Lead Sponsor	Collaborator
Universitas Katolik Widya Mandala Surabaya

Country where clinical trial is conducted

Indonesia, 

Outcome

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