Health TrialsbyHealthPanel

Akkermansia Muciniphilia and Metabolic Side Effects of ADT

ConditionsProstate CancerMetabolic SyndromeObesityCardiovascular MorbidityBone DiseasesHyperlipidemiasDiabetes
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexMale
Age18+
SponsorWestern University

About this trial

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 a standard of care arm. 2. To confirm tolerability and assess for side effects of oral acetate supplementation. 2. Secondary outcomes:

1. To determine if increased counts of A. muciniphilia correlate with improved metabolic parameters and improved bone health.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Must have baseline imaging with 1) CT of the abdomen, and pelvis and bone scan or 2) PSMA PET scan

Age less than 18

Primary neuroendocrine prostate cancer

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Apple Cider Vinegar

    Drug

    Each patient will be instructed to take 1 caplet (equivalent of 143 mg/caplet containing 36% acetic acid) per day for 3 months (NPN: 80078433) https://www.jamiesonvitamins.com/products/apple-cider-vinegar-chromium?srsltid=AfmBOoqdVBFe83\_5JM9BmkomQM1LqsJYSFTiP\_78cnmehfzVg-4T4Z6o

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Apple Cider VinegarExperimental treatment 1 intervention
Group B: ObservationNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Fecal Akkermansia muciniphilia counts

Counts of Akkermansia muciniphilia in participant stool samples at 1 week following the intervention will be compared to baseline counts.

Time frame
1 week
2

Fecal Akkermansia muciniphilia counts

Counts of Akkermansia muciniphilia in participant stool samples at 1 month following the intervention will be compared to baseline counts.

Time frame
1 month
3

Fecal Akkermansia muciniphilia counts

Counts of Akkermansia muciniphilia in participant stool samples at 3 months following the intervention will be compared to baseline counts.

Time frame
3 month
4

Fecal Akkermansia muciniphilia counts

Counts of Akkermansia muciniphilia in participant stool samples at 4 months following the intervention will be compared to baseline counts.

Time frame
4 month

Secondary outcomes

1

Metabolic parameters: fasting plasma glucose

Fasting plasma glucose (mmol/L)

Time frame
3 months
2

Metabolic parameters: fasting plasma glucose

Fasting plasma glucose (mmol/L)

Time frame
6 months
3

Metabolic parameters: HbA1C

HbA1c (%)

Time frame
3 months
4

Metabolic parameters: HbA1c

HbA1c (%)

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Western University

Lead sponsor

Source ClinicalTrials.gov
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