ADAPT: Efficacy of a Dietary Supplement During and After Exercise (ADAPT)
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|ClinicalTrials.gov Identifier: NCT03022214|
Recruitment Status : Completed
First Posted : January 16, 2017
Last Update Posted : December 12, 2018
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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||Phase|
|Dietary Supplementation During Exercise||Dietary Supplement: Placebo Dietary Supplement: Intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
|Actual Primary Completion Date :||February 28, 2018|
|Actual Study Completion Date :||August 31, 2018|
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
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:
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:
- Markers of Oxidative Stress [ Time Frame: 18months ]Plasma TBARS:Plasma TBARS will be measured by HPLC (High Performance Liquid Chromatography).
- Antioxidant enzyme activity [ Time Frame: 18months ]Glutathione peroxidase, superoxide dismutase, and acetaldehyde dehydrogenase will be measured in plasma by spectrophotometer.
- Marker of Oxidative Stress [ Time Frame: 18months ]Plasma F2-Isoprostanes: will be measured by ELISA.
- Markers of Inflammation [ Time Frame: 18months ]Plasma high sensitivity C-Reactive Protein (hs-CRP): Plasma hsCRP will be assessed by automated analysis using KONE.
- Plasma Interleukin-6 (IL-6) [ Time Frame: 18months ]Plasma IL-6 will be assessed by ELISA.
- Plasma Tumour-Necrosis Factor - alpha (TNF-α) [ Time Frame: 18months ]Will be assessed by ELISA.
- Metabolic risk markers [ Time Frame: 18months ]Plasma insulin: Plasma insulin will be assessed by ELISA.
- Plasma glucose [ Time Frame: 18months ]Plasma glucose will be assessed by automated analysis using KONE.
- Plasma non-esterified fatty acids (NEFA) [ Time Frame: 18months ]Will be measured by automated analysis using KONE.
- Markers of muscle damage [ Time Frame: 18 months ]Plasma Creatine Kinase activity will assessed by spectrophotometer Plasma Lactate dehydrogenase activity will assessed by spectrophotometer
- Markers of platelet function [ Time Frame: 18 months ]Thrombin generation
- 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.
- Subjective Ratings [ Time Frame: 18months ]Questionnaires to be applied during exercise challenge test days
- Wellness Questionnaire [ Time Frame: 18months ]To assess lifestyle factors such as fatigue, sleep, and mood.
- 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.
- 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).
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|Ages Eligible for Study:||18 Years to 75 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- 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
- Physician diagnosed diabetes or chronic disease including asthma
- 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
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
|University of Aberdeen, The Rowett Institute|
|Aberdeen, United Kingdom, AB25 2ZD|
|Principal Investigator:||Baukje De Roos, Msc, PhD||The Rowett Institute, University of Aberdeen, Foresterhill, Aberdeen, AB25 2ZD|
|Responsible Party:||University of Aberdeen|
|Other Study ID Numbers:||
|First Posted:||January 16, 2017 Key Record Dates|
|Last Update Posted:||December 12, 2018|
|Last Verified:||December 2018|
|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|