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ADAPT: Efficacy of a Dietary Supplement During and After Exercise (ADAPT)

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ClinicalTrials.gov Identifier: NCT03022214
Recruitment Status : Recruiting
First Posted : January 16, 2017
Last Update Posted : May 5, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

Since 1948, health has been defined as "a state of complete physical, mental and social well-being, and not merely the absence of disease and infirmity" . However, a growing school of thought suggests that health represents an ability to be adaptable and flexible in response to daily stressors. It has been proposed that instead, the view of health should be "towards the ability to adapt and self-manage in the face of social, physical and emotional challenges", which has been termed "resilience".

The theory of "resilience" relates health to the body's capacity to manage daily stressors (such as physical activity or oxidative fluctuations) that challenge homeostasis, with the return to homeostasis resulting from several physiological stress responses. Although this is an all-encompassing model, and the effects of pathogens and other stress factors are also relevant, this study will centre on the physiological aspects on this theory, focussing on the disruption through exercise.


Condition or disease Intervention/treatment
Dietary Supplementation During Exercise Dietary Supplement: Placebo Dietary Supplement: Intervention

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Official Title: ADAPT: Efficacy of a Dietary Supplement to Increase Resilience and Inhibit the Oxidative Stress Response During and After Exercise
Actual Study Start Date : March 22, 2017
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : May 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Placebo
5 capsules of placebo (microcrystalline cellulose) taken once in the morning with breakfast and once in the evening with dinner for two days prior to the study supervised exercise period and then one dose taken on the morning of the exercise test with the first meal
Dietary Supplement: Placebo
Microcrystalline cellulose capsules x 5 morning and night with meals for two days prior to exercise test and 5 capsules taken on the morning of the test with the first meal
Experimental: Intervention

For presentation to volunteers, the daily capsules will be divided into two servings, one serving to be taken in the morning with breakfast, and one serving to be taken in the evening with dinner. Each serving containing 5 capsules, as follows:

  • EnduraCell broccoli sprout powder: 3 capsules
  • Bulk Powders Green tea extract: 1 capsule
  • Bulk Powders Cinnamon Bark Extract: 1 capsule to be taken for two days prior to the study supervised exercise period and then one dose taken on the morning of the exercise test with the first meal
Dietary Supplement: Intervention

Daily capsules will be divided into two servings, one serving to be taken in the morning with breakfast, and one serving to be taken in the evening with dinner. Each serving containing 5 capsules, as follows:

  • EnduraCell broccoli sprout powder: 3 capsules
  • Bulk Powders Green tea extract: 1 capsule
  • Bulk Powders Cinnamon Bark Extract: 1 capsule taken for two days prior to exercise test and 5 capsules taken on the morning of the test with the first meal


Outcome Measures

Primary Outcome Measures :
  1. Markers of Oxidative Stress [ Time Frame: 18months ]
    Plasma TBARS:Plasma TBARS will be measured by HPLC (High Performance Liquid Chromatography).


Secondary Outcome Measures :
  1. Antioxidant enzyme activity [ Time Frame: 18months ]
    Glutathione peroxidase, superoxide dismutase, and acetaldehyde dehydrogenase will be measured in plasma by spectrophotometer.

  2. Marker of Oxidative Stress [ Time Frame: 18months ]
    Plasma F2-Isoprostanes: will be measured by ELISA.

  3. Markers of Inflammation [ Time Frame: 18months ]
    Plasma high sensitivity C-Reactive Protein (hs-CRP): Plasma hsCRP will be assessed by automated analysis using KONE.

  4. Plasma Interleukin-6 (IL-6) [ Time Frame: 18months ]
    Plasma IL-6 will be assessed by ELISA.

  5. Plasma Tumour-Necrosis Factor - alpha (TNF-α) [ Time Frame: 18months ]
    Will be assessed by ELISA.

  6. Metabolic risk markers [ Time Frame: 18months ]
    Plasma insulin: Plasma insulin will be assessed by ELISA.

  7. Plasma glucose [ Time Frame: 18months ]
    Plasma glucose will be assessed by automated analysis using KONE.

  8. Plasma non-esterified fatty acids (NEFA) [ Time Frame: 18months ]
    Will be measured by automated analysis using KONE.

  9. Markers of muscle damage [ Time Frame: 18 months ]
    Plasma Creatine Kinase activity will assessed by spectrophotometer Plasma Lactate dehydrogenase activity will assessed by spectrophotometer

  10. Markers of platelet function [ Time Frame: 18 months ]
    Thrombin generation

  11. Counter Movement Jump [ Time Frame: 18months ]
    This is a test of lower body strength and will be assessed throughout the study visits using a vertical jump meter.

  12. Subjective Ratings [ Time Frame: 18months ]
    Questionnaires to be applied during exercise challenge test days

  13. Wellness Questionnaire [ Time Frame: 18months ]
    To assess lifestyle factors such as fatigue, sleep, and mood.

  14. Perceived Soreness of quadriceps [ Time Frame: 18months ]
    Rating of perceived soreness (pre, post, 48hr post) - Volunteers will rate their perceived soreness in their quadriceps on a ten point scale.

  15. Perceived Exhaustion [ Time Frame: 18months ]
    Ratings of perceived exhaustion (during exercise challenge) - Volunteers will rate their perceived exhaustion using Borg's modified R.P.E scale (10 point).


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy, recreationally active men and women aged 18-25 BMI 18.5-30
  • Healthy, recreationally active men and women aged 50-75 BMI 18.5-30

Exclusion Criteria:

  • Physician diagnosed diabetes or chronic disease including asthma
  • Pregnancy
  • Uncontrolled Hypertension
  • Musculo-skeletal problems
  • Use of some dietary supplements (e.g. antioxidants, fish oils, vitamins_
  • Taking of prescription medicines
  • In the 18-25 group, Physical Activity levels below moderate (Moderate = greater than 2.5 and less than 5.0 hrs /week including 0.5-1.5 hr/week moderate to intense exercise)
  • In the 50-75 group, activity levels below the minimal recommendations for daily physical activity (less than 30 min/day, 5 days/week)
  • Participation in another research study
  • Not being able to speak or understand English
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03022214


Contacts
Contact: Baukje De Roos, Msc, PhD +44 (0) 1224 438629 b.deroos@abdn.ac.uk

Locations
United Kingdom
University of Aberdeen, The Rowett Institute Recruiting
Aberdeen, United Kingdom, AB25 2ZD
Sponsors and Collaborators
University of Aberdeen
Investigators
Principal Investigator: Baukje De Roos, Msc, PhD The Rowett Institute, University of Aberdeen, Foresterhill, Aberdeen, AB25 2ZD
More Information

Responsible Party: University of Aberdeen
ClinicalTrials.gov Identifier: NCT03022214     History of Changes
Other Study ID Numbers: Bdr2017-1
First Posted: January 16, 2017    Key Record Dates
Last Update Posted: May 5, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Aberdeen:
Dietary supplementation
Exercise
Increase Resilience
Oxidative Stress
Efficacy