Table 1 Schedule of HYPRO study visits

Study visit

V0

V1

V2

V3

Time point

Screening

Baseline

Post-intervention

Recovery

Week

− 4 to − 1

0

8

12

Informed consent

x

Inclusion/exclusion criteria

x

Demographics

x

Case history

x

Medication

x

x

x

x

Physical exam

x

Smoking status

x

Height, weight, waist-to-hip ratio

x

Blood pressure, heart rate, ECG

x

Blood sample

x

x

x

x

Urine sample

x

x

x

x

AE/SAE query

x

x

x

Bodyweight and composition (ADP)

x

x

x

Office BP

x

x

x

24-h ABPM

x

x

x

PBMC isolation

x

x

x

Glucose sensor (7 days)

x

x

x

Food record (4 days)

x

x

x

Standardized breakfasts (3 days)

x

x

x

Stool sample

x

x

x

Health-related quality of life (PROMIS-29)

x

x

x