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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-01

Study Completion Date

2022-06-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Effectiveness of a High-Protein Liquid Dietary Supplementation

NCT04911712

Malnutrition Nutritional Status Hospital +3 more

COMPLETED NA

Modulation of Muscle Protein Synthesis With Diet and Exercise in Old Aged Women

NCT02053441

Sarcopenia

COMPLETED

Protein Supplementation Intervention for Improving Muscle Mass and Physical Performance in Older People With Sarcopenia

NCT04516421

Sarcopenia

UNKNOWN NA

Effectiveness of a Nutraceutical in Raising Circulating Serum Vitamin, Mineral and Amino Acid Levels in Patients.

NCT04054505

Vitamin Deficiency

COMPLETED NA

Effect of Protein and Prebiotic Fiber Intake on Adiposity in Overweight and Obese Adults

NCT02217579

Obesity

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dietary Exposure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type OTHER

Isomalto Oligosaccharide

Intervention Type 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)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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)

Intervention Type DIETARY_SUPPLEMENT