VIAging Deceleration Trial Using Metformin, Dasatinib, Rapamycin and Nutritional Supplements

Vitality in Aging Research Group, Inc.

Status and phase: Withdrawn; Phase 1

Conditions: Aging

Treatments: Drug: Study Drugs and Nutritional Supplements

Study type: Interventional

Funder types: Other

Identifiers

NCT04994561

VIA-004

Details and patient eligibility

About

This study aims to assess the safety and efficacy of study drugs and supplements on clinical (structural and functional) signs of aging and to explore/identify other possible biological measures of aging.

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Male or female subjects 65 years of age or older
2. Received full dose of COVID-19 vaccine
3. Fasting Glucose: > 60 - < 125 mg/dl;
4. HbA1C: </= 6.4
5. Vitamin D: > 30 ng/mL
6. Homocysteine < 14 mol/L
7. B12 levels >232 pg/mL
8. Ferritin: > 30 ng/mL
9. Cystatin C: > 0.62 mg/L
10. eGFR > 45 mL/min/1.73 m2
11. BMI > 18 kg/m2 < 35 kg/m²
12. Stable body weight (+/-10 lbs.) over last 6 months
13. Be willing to travel to the study facility as required for this study
14. Be willing to avoid taking antacids 2 hours prior and 2 hours after taking dasatinib
15. Be willing to discontinue proton pump inhibitors
16. Be willing to discontinue St. John's Wort
17. Be willing to discontinue medication/supplements, if applicable, for a washout period and while participating on this study.
18. If taking metformin for anti-aging, willing to washout for 2 months prior to initiating protocol intervention.
19. Be willing to take the investigational product(s) according to schedule and keep a diary for compliance monitoring.
20. Has not participated in another clinical trial within last 30 days
21. If applicable, five years or more post cancer treatment and disease free (define as tumor free or 5 years of clean PET/CT scans).
22. Able to provide signed written informed consent prior to any study specific procedures being performed.

Exclusion criteria

1. Inability to provide written informed consent.
2. ECOG score >/= 2
3. More than 1 alcoholic drinks consumed per day.
4. Anemic (defined as hemoglobin (Hb) levels < 12.0 g/dL in women and < 13.0 g/dL in men)
5. Thrombocytopenia (defined as platelet count < 100 × 10^9/L
6. Neutropenia (defined as < 1.0-1.5 × 10^9 neutrophils/L (mild))
7. Any allergy to any medications or supplements used on this trial.
8. Shellfish or iodine allergy (note: glucosamine sulfate supplement contains shellfish (shrimp, crab)
9. Clinically significant vital signs (e.g. uncontrolled hypertension >/= 180/100) or lab abnormalities (defined as platelet count < 100 × 10^9/L; absolute granulocyte count < 1,000/mm3; ALT (SGOT) > 2.0 times the upper limit of normal range; total bilirubin > 2.5 times the upper limit of normal range) at baseline
10. HIV and/or Hepatitis infection
11. Immunosuppressed due to any condition (e.g. transplant).
12. Taking concurrent medications that may interfere with the drugs or supplements used on this study.
13. Any concurrent uncontrolled medical condition or psychiatric illness which could place the patient at unacceptable risk of study treatment.
14. Other concerns that in the PI's judgment will be a potential safety issue for the subject or that precludes the ability to provide informed consent or complete the study.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Subjects receiving study drugs and nutritional supplements

Experimental group

Description:

All eligible and consented subjects will receive study drugs and nutritional supplements as described in the intervention.

Treatment:

Drug: Study Drugs and Nutritional Supplements