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

Study Overview
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Brief Summary
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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.

Detailed Description
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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)

Official Title
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Does Medium-Term Supplementation With PhytoDyNAmic Affect Exercise Performance and Antioxidant Status in Healthy Men and Women: A Randomized Controlled Trial?

Conditions
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Exercise Performance

Intervention / Treatment
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* Dietary Supplement: PhytoDyNAmic
* Dietary Supplement: Inulin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PhytoDyNAmic<br>Six capsules per day b.i.d. | Dietary Supplement: PhytoDyNAmic<br>* PhytoDyNAmic (6 capsules per day)<br>|
| Placebo Comparator: Inulin<br>Six capsules per day b.i.d. | Dietary Supplement: Inulin<br>* Inulin (6 capsules per day)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in time to exhaustion | Baseline vs. 6 weeks | Baseline vs. 6 weeks post-intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in serum superoxide dismutase | Baseline vs. 6 weeks | Baseline vs. 6 weeks post-intervention | 
| Change in serum total antioxidant capacity | Baseline vs. 6 weeks | Baseline vs. 6 weeks post-intervention | 
| Change in serum telomerase activity | Baseline vs. 6 weeks | Baseline vs. 6 weeks post-intervention |