Body Weight ChangesNCT06132269
Evaluation the Effect of AKK Formula on Intestinal Microbiota Regulation and Body Composition
A study testing AKK formula prebiotic sachet in people with Body Weight Changes and Metabolic Syndrome, run by TCI Co., Ltd. at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Body Weight Changes, Metabolic Syndrome
- What is being tested?
- AKK formula prebiotic sachet
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteTaiwan
- Study dates
- 9 Nov 2023to 1 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- AKK formula prebiotic sachet, Placebo sachet
- Keywords
- Akkermansia muciniphila
- Medical subject headings
- Body Weight Changes, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AKK formula prebiotic sachetDietary 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.
Placebo sachetDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Placebo sachet | Placebo comparator | consume 1 sachet per day for 8 weeks Receives: Dietary Supplement: Placebo sachet |
| AKK formula sachet | Experimental | consume 1 sachet per day for 8 weeks Receives: Dietary Supplement: AKK formula prebiotic sachet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative abundance of Akkermansia muciniphila in gut
Collect subject's feces for bacterial analysis. Akkermansia muciniphila will be quantified by quantitative PCR.
Measured: 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
Measured: 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.
Measured: 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.
Measured: Change from Baseline BMI at 4 weeks, and 8 weeks
Secondary outcomes (14)
The change of total body mass
The total body mass (kg) will be assessed by Bioelectrical impedance analysis (BIA).
Measured: 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).
Measured: Change from Baseline total lean mass at 4 weeks, and 8 weeks
The change of total fat mass
The total fat mass (kg) will be assessed by Bioelectrical impedance analysis (BIA).
Measured: 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).
Measured: 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).
Measured: 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
Measured: 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.
Measured: Change from Baseline insulin sensitivity at 8 weeks
The change of total cholesterol
Venous blood will be sampled to measure concentrations of total cholesterol.
Measured: 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.
Measured: 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.
Measured: Change from Baseline LDL-C at 8 weeks
The change of triglyceride
Venous blood will be sampled to measure concentrations of triglyceride.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: Change from Baseline gastrointestinal tolerability at 4 weeks, and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2023
- Study start9 Nov 2023
- Primary completion30 Jan 2024
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Body Weight ChangesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- TCI Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ming-Ta Yang, Principal investigator, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06132269
- Sponsor's protocol ID
- N202310027
- Status last verified
- May 2024
- First submitted
- 9 Nov 2023
- Last updated
- 6 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation the Effect of AKK Formula on Intestinal Microbiota Regulation and Body Composition
- ClinicalTrials.gov ID
- NCT06132269
- Acronym / sponsor ID
- N202310027
- Conditions
- Body Weight Changes, Metabolic Syndrome
- Keywords
- Akkermansia muciniphila
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- TCI Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 Nov 2023 (actual)
- Primary completion
- 30 Jan 2024 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 15 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo sachet | Placebo comparator | Dietary Supplement: Placebo sachetconsume 1 sachet per day for 8 weeks |
| AKK formula sachet | Experimental | Dietary Supplement: AKK formula prebiotic sachetconsume 1 sachet per day for 8 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (23 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AKK formula prebiotic sachet5 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. | Dietary supplement | AKK formula sachet |
| Placebo sachet5 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. | Dietary supplement | Placebo sachet |
Primary outcome
Relative abundance of Akkermansia muciniphila in gut
Time frame: Change from Baseline relative abundance of A. muciniphila at 8 weeks
Collect subject's feces for bacterial analysis. Akkermansia muciniphila will be quantified by quantitative PCR.
The change of waist circumference
Time frame: Change from Baseline waist circumference at 4 weeks, and 8 weeks
The waist circumference will be assessed by measuring tape. Unit: centimeter
The change of Waist-to-height ratio
Time frame: Change from Baseline Waist-to-height at 4 weeks, and 8 weeks
Waist-to-height ratio can be obtained by dividing waist size by height and is an effective indicator of risks associated with obesity.
The change of body mass index (BMI)
Time frame: Change from Baseline BMI at 4 weeks, and 8 weeks
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.
14 secondary outcomes
The change of total body mass
Time frame: Change from Baseline total body mass at 4 weeks, and 8 weeks
The change of total lean mass
Time frame: Change from Baseline total lean mass at 4 weeks, and 8 weeks
The change of total fat mass
Time frame: Change from Baseline total fat mass at 4 weeks, and 8 weeks
The change of total fat rate
Time frame: Change from Baseline total fat rate at 4 weeks, and 8 weeks
The change of visceral fat volume
Time frame: Change from Baseline visceral fat volume at 4 weeks, and 8 weeks
The change of hip circumference
Time frame: Change from Baseline hip circumference at 4 weeks, and 8 weeks
The change of insulin sensitivity
Time frame: Change from Baseline insulin sensitivity at 8 weeks
The change of total cholesterol
Time frame: Change from Baseline total cholesterol at 8 weeks
The change of High Density Lipoprotein Cholesterol (HDL-C)
Time frame: Change from Baseline HDL-C at 8 weeks
The change of Low Density Lipoprotein Cholesterol (LDL-C)
Time frame: Change from Baseline LDL-C at 8 weeks
The change of triglyceride
Time frame: Change from Baseline triglyceride at 8 weeks
The change of intestinal microbiota
Time frame: Change from Baseline intestinal microbiota at 8 weeks
The change of gastrointestinal tolerability
Time frame: Change from Baseline gastrointestinal tolerability at 4 weeks, and 8 weeks
The change of stool type
Time frame: Change from Baseline gastrointestinal tolerability at 4 weeks, and 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ming-Ta Yang principal investigator
Taipei Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AKK formula prebiotic sachet in people with Body Weight Changes and Metabolic Syndrome, run by TCI Co., Ltd. at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative abundance of Akkermansia muciniphila in gut (time frame: Change from Baseline relative abundance of A. muciniphila at 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2024.