Akkermansia Muciniphilia and Metabolic Side Effects of ADT

Obesity Clinical Trial

Official title:

The Role of Akkermansia Muciniphilia in Combating the Metabolic Effects of Androgen Deprivation Therapy in Men With Metastatic Prostate Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05802121
• Other study ID #: ReDA ID 12558
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: June 2023
• Est. completion date: June 2026

Study information

• Verified date: March 2023
• Source: Western University
• Contact: Kaydee Connors
• Phone: 519-685-8500
• Email: kaydee.connors[@]lhsc.on.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The overriding objectives of this study are: 1. Primary outcomes: 1. To confirm that administration of oral acetate increases the proportion of A. muciniphilia in the stool samples of patients with metastatic, castration-sensitive prostate cancer compared to placebo. 2. To confirm tolerability and assess for side effects of delayed oral acetate supplementation. 2. Secondary outcomes: 1. To determine if increased counts of A. muciniphilia correlate with improved metabolic parameters and improved bone health.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: June 2026
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

For inclusion in this study, patients must fulfill all of the following criteria:

1. Men =18 years of age with histologically-proven metastatic castration-sensitive prostate adenocarcinoma planned to receive ADT (TNM stage Tany, Nany, M1) (see Appendix I).

2. Must have baseline conventional imaging with CT of the abdomen, and pelvis and bone scan. Exclusion Criteria: Patients fulfilling any of the following criteria are NOT eligible for participation in

this study:

1. Age less than 18

2. Primary neuroendocrine prostate cancer

3. Treatment with ADT within the year leading up to enrolment

4. Unable to provide informed consent or unable to understand or read the English language (unless accompanied by an interpreter)

5. Inadequate liver function

Related Conditions & MeSH terms

• Bone Diseases
• Cardiovascular Morbidity
• Diabetes
• Hyperlipidemias
• Metabolic Syndrome
• Obesity
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Apple Cider Vinegar
Each patient will be instructed to take 6 enteric slow-release acetate capsules (equivalent of 500 mg/ capsule containing 25 mg acetate x 6 capsules) per day for 3 months https://www.webbernaturals.com/en-ca/apple-cider-vinegar-500-mg-capsules/
• Placebo
Each patient will be instructed to take 6 placebo capsules per day for 3 months

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Western University

References & Publications (26)

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van der Beek CM, Canfora EE, Lenaerts K, Troost FJ, Damink SWMO, Holst JJ, Masclee AAM, Dejong CHC, Blaak EE. Distal, not proximal, colonic acetate infusions promote fat oxidation and improve metabolic markers in overweight/obese men. Clin Sci (Lond). 2016 Nov 1;130(22):2073-2082. doi: 10.1042/CS20160263. Epub 2016 Jul 20. — View Citation

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* Note: There are 26 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fecal Akkermansia muciniphilia counts	Counts of Akkermansia muciniphilia in participant stool samples at 1 week following the intervention will be compared to baseline counts.	1 week
Primary	Fecal Akkermansia muciniphilia counts	Counts of Akkermansia muciniphilia in participant stool samples at 1 month following the intervention will be compared to baseline counts.	1 month
Primary	Fecal Akkermansia muciniphilia counts	Counts of Akkermansia muciniphilia in participant stool samples at 3 months following the intervention will be compared to baseline counts.	3 month
Primary	Fecal Akkermansia muciniphilia counts	Counts of Akkermansia muciniphilia in participant stool samples at 4 months following the intervention will be compared to baseline counts.	4 month
Primary	Fecal Akkermansia muciniphilia counts	Counts of Akkermansia muciniphilia in participant stool samples at 6 months following the intervention will be compared to baseline counts.	6 month
Primary	Side effects and tolerability	We will record side effects reported by the participants and the rate of Discontinuation of the intervention.	3 months
Secondary	Metabolic parameters: fasting plasma glucose	Fasting plasma glucose (mmol/L)	3 months
Secondary	Metabolic parameters: fasting plasma glucose	Fasting plasma glucose (mmol/L)	6 months
Secondary	Metabolic parameters: HbA1C	HbA1c (%)	3 months
Secondary	Metabolic parameters: HbA1c	HbA1c (%)	6 months
Secondary	Metabolic parameters: triglycerides	Triglycerides (mmol/L)	3 months
Secondary	Metabolic parameters: triglycerides	Triglycerides (mmol/L)	6 months
Secondary	Metabolic parameters: LDL cholesterol	LDL cholesterol (mmol/L)	3 months
Secondary	Metabolic parameters: LDL cholesterol	LDL cholesterol (mmol/L)	6 months
Secondary	Metabolic parameters: HDL cholesterol	HDL cholesterol (mmol/L)	3 months
Secondary	Metabolic parameters: HDL cholesterol	HDL cholesterol (mmol/L)	6 months
Secondary	Metabolic parameters: total cholesterol	Total cholesterol (mmol/L)	3 months
Secondary	Metabolic parameters: total cholesterol	Total cholesterol (mmol/L)	6 months
Secondary	Metabolic parameters: PSA	PSA (ng/mL)	6 months
Secondary	Metabolic parameters: PSA	PSA (ng/mL)	3 months
Secondary	Metabolic parameters: hemoglobin	Hemoglobin (g/L)	3 months
Secondary	Metabolic parameters: hemoglobin	Hemoglobin (g/L)	6 months
Secondary	Metabolic parameters: serum creatinine	Serum creatinine (µmol/L)	3 months
Secondary	Metabolic parameters: serum calcium	Serum calcium (µmol/L)	3 months
Secondary	Metabolic parameters: serum calcium	Serum calcium (µmol/L)	6 months
Secondary	Metabolic parameters: alanine transferase	Alanine transferase (U/L)	3 months
Secondary	Metabolic parameters: alanine transferase	Alanine transferase (U/L)	6 months
Secondary	Metabolic parameters: aspartate aminotransferase	Aspartate aminotransferase (U/L)	3 months
Secondary	Metabolic parameters: aspartate aminotransferase	Aspartate aminotransferase (U/L)	6 months
Secondary	Metabolic parameters: Insulin resistance index (HOMA IR)	Insulin resistance index (HOMA IR)	3 months
Secondary	Metabolic parameters: HOMA IR	Insulin resistance index (HOMA IR)	6 months
Secondary	Bone health: dp-ucMGP levels	Circulating plasma dp-ucMGP levels (surrogate for vitamin K2 levels) from baseline	3 months
Secondary	Bone health: dp-ucMGP levels	Circulating plasma dp-ucMGP levels (surrogate for vitamin K2 levels) from baseline	6 months
Secondary	Bone health: Vitamin K2	Vitamin K2 levels	3 months
Secondary	Bone health: Vitamin K2	Vitamin K2 levels	6 months