Clinical trial NCT05455164: The Effect of Eucaloric High-Protein Fiber Diet in Healthy Adults: A Repeated Single-Arm 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dietary Exposure
Keywords: isomalto-oligosaccharide
blood glucose
cholesterol
fibre diet
Lead sponsor: Universitas Katolik Widya Mandala Surabaya
Sponsor class: OTHER
First posted: 2022-07-13
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: body composition analysis (Arm-, Trunk-, Leg Fat composition)
timeFrame: 2 weeks after meal
measure: Fasting Plasma Glucose
timeFrame: 2 weeks after meal
measure: Plasma Uric Acid
timeFrame: 2 weeks after meal
measure: Total Cholesterol
timeFrame: 2 weeks after meal
Secondary outcomes:
Other outcomes:
Locations:
city: Surabaya
country: Indonesia
facility: Universitas Katolik Widya Mandala Surabaya
state: Jawa Timur
Study officials:
affiliation: Faculty of Pharmacy, Universitas Katolik Widya Mandala Surabaya
name: Hendy Wijaya, MD.M.Biomed.
role: PRINCIPAL_INVESTIGATOR
References: