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

NCT06132269 | Completed

• 1 other identifier: N202310027
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Body Weight Changes; Metabolic Syndrome

Keywords

Akkermansia muciniphila

Outcome Measures

Primary Outcomes (4)

• Relative abundance of Akkermansia muciniphila in gut

  Collect subject's feces for bacterial analysis. Akkermansia muciniphila will be quantified by quantitative PCR.

  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

  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.

  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.

  Change from Baseline BMI at 4 weeks, and 8 weeks

Secondary Outcomes (14)

• The change of total body mass

  Change from Baseline total body mass at 4 weeks, and 8 weeks

• The change of total lean mass

  Change from Baseline total lean mass at 4 weeks, and 8 weeks

• The change of total fat mass

  Change from Baseline total fat mass at 4 weeks, and 8 weeks

• The change of total fat rate

  Change from Baseline total fat rate at 4 weeks, and 8 weeks

• The change of visceral fat volume

  Change from Baseline visceral fat volume at 4 weeks, and 8 weeks

Study Arms (2)

Placebo sachet

PLACEBO COMPARATOR

consume 1 sachet per day for 8 weeks

Dietary Supplement: Placebo sachet

AKK formula sachet

EXPERIMENTAL

consume 1 sachet per day for 8 weeks

Dietary Supplement: AKK formula prebiotic sachet

Interventions

AKK formula prebiotic sachet 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.

AKK formula sachet

Placebo sachet 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.

Placebo sachet

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• TCI Co., Ltd.: lead

Study Sites (1)

Taipei Medical University

Taipei, 110, Taiwan

Location

MeSH Terms

Conditions

Body Weight Changes; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Ming-Ta Yang

  Taipei Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2023
• First Posted: November 15, 2023
• Study Start: November 9, 2023
• Primary Completion: January 30, 2024
• Study Completion: May 1, 2024
• Last Updated: May 6, 2024

Record last verified: 2024-05

Locations

TW (1)