The AKK formula, a prebiotic blend, can effectively promote the proliferation of A. muciniphila. In this study, we attempt to explore the clinical efficacy of AKK formula for A. muciniphila proliferation and weight management.
This is a double-blind, randomized, parallel and placebo-controlled study. Subjects are informed to consume the samples daily for 8 weeks. The person who is evaluated as obesity by the investigator will be invited to participate in this trial. In this study, we attempt to explore the clinical efficacy of AKK formula for A. muciniphila proliferation and weight management.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
70
5 g/sachet, containing AKK formula, Indigestible Maltodextrin, Crystalline Maltitol, Calcium Carbonate, Citric Acid, Steviol Glycosides, and flavor. Subjects will consume 1 sachet per day for 8 weeks.
5 g/sachet, containing Indigestible Maltodextrin, Crystalline Maltitol, Calcium Carbonate, Citric Acid, Steviol Glycosides, and flavor. Subjects will consume 1 sachet per day for 8 weeks.
Taipei Medical University
Taipei, Taiwan
Relative abundance of Akkermansia muciniphila in gut
Collect subject's feces for bacterial analysis. Akkermansia muciniphila will be quantified by quantitative PCR.
Time frame: Change from Baseline relative abundance of A. muciniphila at 8 weeks
The change of waist circumference
The waist circumference will be assessed by measuring tape. Unit: centimeter
Time frame: Change from Baseline waist circumference at 4 weeks, and 8 weeks
The change of Waist-to-height ratio
Waist-to-height ratio can be obtained by dividing waist size by height and is an effective indicator of risks associated with obesity.
Time frame: Change from Baseline Waist-to-height at 4 weeks, and 8 weeks
The change of body mass index (BMI)
BMI is a measurement of a person's leanness or corpulence based on their height and weight, and is intended to quantify tissue mass.The body mass index (BMI, kg/m\^2) and body mass (kg) will be assessed by InBody.
Time frame: Change from Baseline BMI at 4 weeks, and 8 weeks
The change of total body mass
The total body mass (kg) will be assessed by Bioelectrical impedance analysis (BIA).
Time frame: Change from Baseline total body mass at 4 weeks, and 8 weeks
The change of total lean mass
The total lean mass (kg) will be assessed by Bioelectrical impedance analysis (BIA).
Time frame: Change from Baseline total lean mass at 4 weeks, and 8 weeks
The change of total fat mass
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The total fat mass (kg) will be assessed by Bioelectrical impedance analysis (BIA).
Time frame: Change from Baseline total fat mass at 4 weeks, and 8 weeks
The change of total fat rate
The total fat rate (%) will be assessed by Bioelectrical impedance analysis (BIA).
Time frame: Change from Baseline total fat rate at 4 weeks, and 8 weeks
The change of visceral fat volume
The visceral fat volume (cm\^2) will be assessed by Bioelectrical impedance analysis (BIA).
Time frame: Change from Baseline visceral fat volume at 4 weeks, and 8 weeks
The change of hip circumference
The hip circumference will be assessed by measuring tape. Unit: centimeter
Time frame: Change from Baseline hip circumference at 4 weeks, and 8 weeks
The change of insulin sensitivity
Insulin sensitivity is assessed by HOMA-IR. HOMA-IR= fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5. Venous blood will be sampled to measure concentrations of fasting glycemia and insulin.
Time frame: Change from Baseline insulin sensitivity at 8 weeks
The change of total cholesterol
Venous blood will be sampled to measure concentrations of total cholesterol.
Time frame: Change from Baseline total cholesterol at 8 weeks
The change of High Density Lipoprotein Cholesterol (HDL-C)
Venous blood will be sampled to measure concentrations of HDL-C.
Time frame: Change from Baseline HDL-C at 8 weeks
The change of Low Density Lipoprotein Cholesterol (LDL-C)
Venous blood will be sampled to measure concentrations of LDL-C.
Time frame: Change from Baseline LDL-C at 8 weeks
The change of triglyceride
Venous blood will be sampled to measure concentrations of triglyceride.
Time frame: Change from Baseline triglyceride at 8 weeks
The change of intestinal microbiota
Collect subject's feces for bacterial analysis. Intestinal microbiota will be assessed by Next Generation Sequencing (NGS).
Time frame: Change from Baseline intestinal microbiota at 8 weeks
The change of gastrointestinal tolerability
Gastointestinal tolerability will be assessed by The Gastrointestinal Symptom Rating Scale (GSRS).The GSRS has a seven-point graded Likert-type scale where 1 represents absence of troublesome symptoms and 7 represents very troublesome symptoms.
Time frame: Change from Baseline gastrointestinal tolerability at 4 weeks, and 8 weeks
The change of stool type
The stool type will be assessed by The Bristol Stool Form Scale (BSFS) daily. The BSFS is a scale that classifies stools, ranging from the hardest (type 1) to the softest (type 7).
Time frame: Change from Baseline gastrointestinal tolerability at 4 weeks, and 8 weeks