Medium-Term Supplementation With Herbal Extract for Exercise Performance and Antioxidant Status (PhytoDyNAmic)

University of Novi Sad, Faculty of Sport and Physical Education

Status: Completed

Conditions: Exercise Performance

Treatments: Dietary Supplement: PhytoDyNAmic; Dietary Supplement: Inulin

Study type: Interventional

Funder types: Other

Identifiers

NCT04263246

320-PDY/2019

Details and patient eligibility

About

We evaluated here the effects of 6-week intervention with herbal supplement on exercise performance outcomes and serum biomarkers of antioxidant status. In addition, we also assessed the long-term effects (6-month) of the intervention in elderly adults.

Full description

Experimental protocol

• Double-blind, randomized, placebo-controlled cross-over trial
• 6-week intervention trial (with additiional follow-up arm after 6 months)
• Experimental intervention (PhytoDyNAmic) = 6 capsules per day
• Placebo (inulin) = 1 g per day b.i.d.
• Administration = 3 capsules with breakfast and 3 capsules with dinner
• Wash-out period = 2 weeks
• No changes in physical activity patterns and diet during the study

Outcomes assessed at baseline and at each follow-up:

• Exercise performance during incremental running-to-exhaustion test
• Serum biomarkers of antioxidant status
• Total antioxidant capacity (TAC)
• Superoxide dismutase (SOD)
• Telomerase activity

Early termination criteria

• Serious subjective side effects of an intervention (e.g. nausea, vomiting, bloating)

Enrollment: 12 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age ≥ 18 years
• Body mass index 19 - 25 kg/m2
• Free of major chronic diseases or acute disorders

Exclusion criteria

• Use of dietary supplements within 4 weeks before study commences
• Unwillingness to return for follow-up analysis

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

---

12 participants in 2 patient groups, including a placebo group

PhytoDyNAmic

Experimental group

Description:

Six capsules per day b.i.d.

Treatment:

Dietary Supplement: PhytoDyNAmic

Inulin

Placebo Comparator group

Description:

Six capsules per day b.i.d.

Treatment:

Dietary Supplement: Inulin