Evaluation the Effect of AKK Formula on Intestinal Microbiota Regulation and Body Composition

NCT ID: NCT06132269

Last Updated: 2024-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-09
• Study Completion Date: 2024-05-01

Brief Summary

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.

Detailed Description

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.

Conditions

Body Weight Changes; Metabolic Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Placebo sachet

consume 1 sachet per day for 8 weeks

Group Type: PLACEBO_COMPARATOR

Placebo sachet

Intervention Type: DIETARY_SUPPLEMENT

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.

AKK formula sachet

consume 1 sachet per day for 8 weeks

Group Type: EXPERIMENTAL

AKK formula prebiotic sachet

Intervention Type: DIETARY_SUPPLEMENT

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.

Interventions

AKK formula prebiotic sachet

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.

Intervention Type: DIETARY_SUPPLEMENT

Placebo sachet

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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Subjects shall have a body mass index (BMI) of >23.0 to <32.5.0 kg/m2.
• Subjects shall have waist circumference of >80 cm for men and women.
• Subject is willing to maintain habitual dietary, lifestyle, and physical activity throughout the trial and do not plan to change the place of living during the study.
• Subject understands the study procedures and signs forms providing informed consent to participate in the study and authorizes the release of relevant protected health information to the Study Investigator.

Exclusion Criteria

• Clinically important gastrointestinal condition that would potentially interfere with the evaluation of study products (e.g., inflammatory bowel disease, irritable bowel syndrome, gastric reflux, indigestion, dyspepsia, Crohn's disease, celiac disease, history of gastrointestinal surgical intervention for inducing weight loss, gastroparesis, and clinically significant lactose or gluten intolerance or other food/food component allergies).
• Recent (within 2 weeks of Visit 1, Day -7 - screening visit) history of an episode of acute GI illness such as nausea/vomiting or diarrhea (defined as >3 loose or liquid stools/d).
• Self-reported history (within 6 weeks of Visit 1, Day -7 -screening visit) of constipation (< 3 bowel movements/week) or diarrhea (loose stools >3 loose or liquid stools in one day) that in the judgement of the Study Investigator is not due to acute infection (e.g., stomach flu), food poisoning, temporary medication, etc.
• Subjests with mental disorder(depression, schizophrenia), cardiovascular disease/Arrhythmia/Heart Failure/Myocardial Infarction/or other Heart Condition, Hypothyroidism Or Uncontrolled Diabetic Gastrointestinal Disease (Crohn's Disease)/Gastrointestinal Resection Surgery/Irritable Bowel Syndrome, kidney condition, autoimmune disorder, Thyroid or hormonal abnormalities/Abnormalities If the immune system that can affect the weight of thyroid levels, like anemia/porphyrinosis, pancreatitis etc .
• Uncontrolled hypertension (systolic blood pressure ≥140 mm Hg or diastolic blood pressure ≥90 mm Hg) as defined by blood pressure measured on Visit 1. Stable use of hypertension medication is allowed (defined as no change in medication regimen within the 3 mo prior to Visit 1.)
• Any known food allergy, intolerance, or sensitivity to study product ingredients.
• Extreme dietary habits, eating disorders or physical activity patterns at the discretion of the Study Investigator.
• History or presence of cancer in the prior 2 years, except for non-melanoma skin cancer.
• Major trauma or any other surgical event within 3 months of Visit 1.
• Signs or symptoms of an active infection of clinical relevance within 5 days of Visit 1.
• Weight loss or gain >4.5 kg in the 3 months prior to Visit 1.
• Current use or planned use/participation in any weight loss regimen during the study period.
• Anti-biotic, antifungal, or antiparasitic use within 3 months of Visit 1 and throughout the study period.
• Use of anti-obesity, blood sugar lowering medications, insulin injections, hormones, diuretics , hormoneal treatment orsteroids within 1 month of Visit 1 and throughout the study period. Use of nasal and non-prescription topical treatments is permitted.
• Chronic use (i.e., daily or on a regular basis) of anti-inflammatory medications (e.g., NSAIDS) within 1 month of Visit 1.
• Use of medications (over-the-counter or prescription) and/or dietary supplements known to influence GI function including, but not limited to prebiotics, probiotics laxatives and/or enemas - including suppositories, fiber supplements, H2 blockers, proton pump inhibitors, antacids, anti-diarrheal agents, antidepressants, and/or anti-spasmodics within 3 weeks of Visit 1. Standard multi-vitamin/multi-mineral supplements are permitted.
• Subject has undergone endoscopy or endoscopy preparation within 3 months prior to Visit 1.
• Exposure to any non-registered drug product, including street drugs, within 4 weeks prior to Visit 1.
• Recent history (within 12 months of Visit 1) of alcohol or substance abuse. Alcohol abuse is defined as >14 drinks/week (1 drink = 12 oz (354 ml) beer, 5 oz (148 ml), or 1 ½ oz (44 ml) distilled spirits).
• Subject has a condition that, in the opinion of the Study Investigator, would interfere with his/her ability to provide informed consent, comply with the study protocol, confound interpretation of study results, or place the subject at undue risk.
• Female subjects who typically experience changes in GI symptoms or bowel habits (e.g., increased or decreased laxation, bloating, abdominal cramping) at the time of menstruation.
• Female subjects with irregular menstruation which does not allow for easy scheduling of stool collection outside of the menstrual period.
• Female subject who is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and is unwilling to commit to the use of a medically approved form of contraception throughout the study period. Subjects who become pregnant during the study will be dismissed from the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

TCI Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ming-Ta Yang

Role: PRINCIPAL_INVESTIGATOR

Taipei Medical University

Locations

Taipei Medical University

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

N202310027

Identifier Type: -

Identifier Source: org_study_id