ADAPT: Efficacy of a Dietary Supplement During and After Exercise

NCT03022214 | Completed

• 1 other identifier: Bdr2017-1
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Dietary Supplementation During Exercise

Keywords

Dietary supplementation; Exercise; Increase Resilience; Oxidative Stress; Efficacy

Outcome Measures

Primary Outcomes (1)

• Markers of Oxidative Stress

  Plasma TBARS:Plasma TBARS will be measured by HPLC (High Performance Liquid Chromatography).

  18months

Secondary Outcomes (15)

• Antioxidant enzyme activity

  18months

• Marker of Oxidative Stress

  18months

• Markers of Inflammation

  18months

• Plasma Interleukin-6 (IL-6)

  18months

• Plasma Tumour-Necrosis Factor - alpha (TNF-α)

  18months

Study Arms (2)

Placebo

EXPERIMENTAL

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

Intervention

EXPERIMENTAL

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

Interventions

Placebo DIETARY_SUPPLEMENT

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

Placebo

Intervention DIETARY_SUPPLEMENT

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

Intervention

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aberdeen: lead

Study Sites (1)

University of Aberdeen, The Rowett Institute

Aberdeen, AB25 2ZD, United Kingdom

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Methods

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Baukje De Roos, Msc, PhD

  The Rowett Institute, University of Aberdeen, Foresterhill, Aberdeen, AB25 2ZD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2017
• First Posted: January 16, 2017
• Study Start: March 22, 2017
• Primary Completion: February 28, 2018
• Study Completion: August 31, 2018
• Last Updated: December 12, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)