- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07491705
Camel Milk Impact on Aerobic Exercise Recovery, Induced Inflammation, and Physical Performance
Study title Camel Milk Impact on Aerobic Exercise Recovery, Induced Inflammation, and Physical Performance
Investigator Dr. Mo'ath Bataineh Department of Nutrition and Health College of Medicine & Health Sciences United Arab Emirates University Brief Summary This study aims to examine the effects of post-exercise camel milk consumption on recovery and subsequent high-intensity cycling performance in recreationally trained adult males. The primary objective is to determine whether camel milk improves time to exhaustion and overall workload compared with cow's milk or water. Secondary objectives include assessing its impact on muscle soreness, muscle damage, and inflammatory markers following intense exercise.
Participants are healthy, non-obese males over 18 years of age with no milk allergies and not using antioxidant supplements, anti-inflammatory drugs, or antibiotics. A total of 12 individuals will be enrolled.
The study involves four laboratory visits. The first includes an educational workshop on recording diet and exercise, development of an individualized standardized diet, and baseline assessments of body measurements and aerobic performance (peak work rate, heart rate, maximum speed at exhaustion, and VO₂max). The remaining three visits occur 4-5 days apart. In each session, resting physiological measures are recorded, followed by a cycling exercise. Participants then consume the assigned experimental beverage and rest for 210 minutes before completing a second cycling test. Four blood samples are collected per visit at designated time points.
Participation is voluntary, and individuals may withdraw at any time. There are no anticipated risks beyond potential discomfort from some questions or procedures. Although participants may not receive direct personal benefit, the findings may contribute to improved understanding of exercise recovery strategies.
All collected information will remain confidential, with identifying data stored securely and not included in any publications. Study results will be disseminated through peer-reviewed journals, conferences, and required reports to UAEU's Human Research Ethics Committee and the Research Office. The project is conducted and funded by United Arab Emirates University and has received ethical approval by UAEU Human Ethics Committee on February 7, 2024, (ERH_2023_3935).
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study title Camel Milk Impact on Aerobic Exercise Recovery, Induced Inflammation, and Physical Performance
Investigator Dr. Mo'ath Bataineh Department of Nutrition and Health College of Medicine & Health Sciences United Arab Emirates University Detailed Description of the Study and Procedures
Study Overview The research project, titled "Camel Milk Impact on Aerobic Exercise Recovery, Induced Inflammation, and Physical Performance," examines the physiological effects of post exercise camel milk consumption on high intensity cycling performance in recreationally trained adult males. The study was issued and approved on March 6, 2024, by the UAEU Human Research Ethics Committee.
The investigation is conducted by Dr. Mo'ath Bataineh, Amjad Jarrar, and Zein Najjar from the Nutrition and Health Department, College of Medicine & Health Sciences, United Arab Emirates University.
Purpose of the Study The primary objective is to determine whether consuming camel milk after strenuous exercise improves subsequent high intensity cycling performance.
The secondary objectives include assessing the effects of camel milk on:
- Muscle damage
- Muscle soreness
- Inflammatory markers (IL 6, TNF α, IL 10)
- Time to exhaustion and workload capacity
The central hypothesis is that camel milk consumption during recovery will:
- Enhance time to exhaustion and workload, and
- Attenuate increases in pro inflammatory markers, more effectively than cow's milk or water.
Participant Eligibility
Participants are selected based on the following criteria:
- Male, non obese, over 18 years old
- No milk allergy
- Not consuming antioxidant or anti inflammatory supplements
- Not taking anti inflammatory drugs or antibiotics A total of 12 participants are enrolled.
- Participant Rights and Voluntary Participation Participation is strictly voluntary. Individuals may withdraw at any time without providing a reason. A participant information sheet and consent form are provided.
- Study Procedures 5.1 Number of Visits
Participants complete four laboratory visits:
Visit 1 - Training & Baseline Measurements
- Educational workshop on accurate food and exercise logging
- Design of individualized standardized diet including 2 daily servings of dairy
Measurements collected:
- Height and weight
- Peak work rate
- Heart rate
- Maximum speed at exhaustion
- VO₂MAX Visits 2-4 - Testing Days
Visits occur 4-5 days apart. Each visit includes:
- Baseline measurements: resting heart rate, blood pressure, oxygen consumption, and CO₂ production
- First cycling exercise on a bicycle ergometer
Recovery period:
- Immediate consumption of the assigned recovery beverage (camel milk, cow's milk, or water)
- 210 minute rest period
- Second cycling exercise
- Blood sampling at four time points: pre exercise, mid exercise, end of exercise, and during recovery
Measurement Protocols 6.1 Anthropometric Measurements
- Height: Measured on a digital column scale following standardized positioning guidelines.
- Body Composition: Measured using the InBody 720. Participants refrain from food/drink for 3 hours and empty bladder 30 minutes before testing.
6.2 Exercise Performance Testing
- Peak Power Output (PPO): Assessed using a cycle ergometer with warming-up procedures and gradual resistance increase.
- Heart Rate: Measured using the Polar H10 sensor.
- VO₂MAX: Determined using a calibrated metabolic cart (21-23 °C; reference gases 16% O₂, 3.99% CO₂).
Biological Sampling and Laboratory Analyses 7.1 Blood Sampling Performed by a licensed technician. Steps include vein identification, sterile needle insertion, sample labeling, and proper storage at 4-8 °C for ≤24 hours.
7.2 Plasma Collection Blood is centrifuged at 3200-3500 rpm for 10-15 minutes. Plasma is stored at -80 °C.
7.3 Hemoglobin & Hematocrit Measured using HemoCue following standardized finger prick and cuvette handling procedures.
7.4 Creatine Kinase (CK) Assayed using the cobas c111 analyzer with reagent loading, calibration, QC checks, and automated calculation.
7.5 Cytokines
- IL 6: Measured using cobas e411 with reagent preparation, calibration, and QC.
- TNF α and IL 10: Assessed using ELISA with standard preparation, incubation, washing, TMB development, and absorbance reading at 450 nm.
- Risks and Benefits There are no physical risks expected from participation. Participants may skip any question they find uncomfortable. While there may be no direct benefits, the study contributes to improved understanding of exercise recovery strategies.
Confidentiality
All collected data remain strictly confidential:
- No names are recorded on forms.
- Data are accessible only to the research team.
- Electronic files are stored on password protected devices.
- Consent forms are stored securely in the PI's office.
- Publications and reports use group-level anonymized data only.
Dissemination of Results
Results will be:
- Published in international peer reviewed journals
- Presented at scientific conferences
- Reported to the UAEU Human Research Ethics Committee and UAEU Research Office No individually identifiable data will be shared.
- Funding and Oversight The study is organized by United Arab Emirates University and funded by the UAEU Research Office. Ethical oversight is provided by the UAEU Human Research Ethics Committee on February 7, 2024, (ERH_2023_3935).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Abu Dhabi Emirate
-
Al Ain City, Abu Dhabi Emirate, United Arab Emirates, 15551
- United Arab Emirates University Building E3 Room 0015
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Recreational athlete
- Active 5 Days a Week
- Male
- Healthy
- Non-Obese
- 18 to 30 years old
- No allergies to milk.
Exclusion Criteria:
- Sedentary
- Female
- Allergies to milk
- Presence of diseases
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Control
No treatment
|
Twelve recreationally trained healthy male participants will be recruited to perform three cycling to volitional exhaustion trials followed by 4-hour recovery period and a subsequent exercise capacity test.
Following conclusion of the cycling exercise session and within a period of 30 minutes at the start of the recovery period from the cycling exercise, an equal 500 ml volume of either water, cow milk, or camel milk will be consumed in a crossover counterbalanced design.
Time to exhaustion, heart rate (HR), rating of perceived exertion (RPE), oxygen consumption, carbon dioxide production, and workload will be recorded per trial.
Blood samples will be collected before and after exercise to determine plasma levels of systemic cytokines (IL-6, IL-10, TNF-α) and creatine kinase (CK).
|
|
Experimental: Camel Milk
Received camel milk
|
Twelve recreationally trained healthy male participants will be recruited to perform three cycling to volitional exhaustion trials followed by 4-hour recovery period and a subsequent exercise capacity test.
Following conclusion of the cycling exercise session and within a period of 30 minutes at the start of the recovery period from the cycling exercise, an equal 500 ml volume of either water, cow milk, or camel milk will be consumed in a crossover counterbalanced design.
Time to exhaustion, heart rate (HR), rating of perceived exertion (RPE), oxygen consumption, carbon dioxide production, and workload will be recorded per trial.
Blood samples will be collected before and after exercise to determine plasma levels of systemic cytokines (IL-6, IL-10, TNF-α) and creatine kinase (CK).
|
|
Experimental: Cow Milk
Received cow milk
|
Twelve recreationally trained healthy male participants will be recruited to perform three cycling to volitional exhaustion trials followed by 4-hour recovery period and a subsequent exercise capacity test.
Following conclusion of the cycling exercise session and within a period of 30 minutes at the start of the recovery period from the cycling exercise, an equal 500 ml volume of either water, cow milk, or camel milk will be consumed in a crossover counterbalanced design.
Time to exhaustion, heart rate (HR), rating of perceived exertion (RPE), oxygen consumption, carbon dioxide production, and workload will be recorded per trial.
Blood samples will be collected before and after exercise to determine plasma levels of systemic cytokines (IL-6, IL-10, TNF-α) and creatine kinase (CK).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time to Exhaustion (minutes)
Time Frame: From enrollment to the end of treatment at 6 hours
|
Duration of the cycling-to-exhaustion test recorded in minutes
|
From enrollment to the end of treatment at 6 hours
|
|
Exercise Capacity (workload in watts)
Time Frame: From enrollment to the end of treatment at 6 hours
|
Maximum workload achieved during the post recovery exercise capacity test
|
From enrollment to the end of treatment at 6 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Heart Rate (beats per minute)
Time Frame: From enrollment to the end of treatment at 6 hours
|
Mean and peak HR recorded throughout exercise sessions
|
From enrollment to the end of treatment at 6 hours
|
|
Rating of Perceived Exertion (RPE units)
Time Frame: From enrollment to the end of treatment at 6 hours
|
RPE assessed using the Borg scale during exercise
|
From enrollment to the end of treatment at 6 hours
|
|
Oxygen Consumption (VO₂; mL·kg-¹·min-¹)
Time Frame: From enrollment to the end of treatment at 6 hours
|
VO₂ continuously measured during exercise
|
From enrollment to the end of treatment at 6 hours
|
|
Carbon Dioxide Production (VCO₂; mL·kg-¹·min-¹)
Time Frame: From enrollment to the end of treatment at 6 hours
|
VCO₂ continuously measured during exercise
|
From enrollment to the end of treatment at 6 hours
|
|
Plasma Cytokines (pg/mL)
Time Frame: From enrollment to the end of treatment at 6 hours
|
|
From enrollment to the end of treatment at 6 hours
|
|
Creatine Kinase (U/L)
Time Frame: From enrollment to the end of treatment at 6 hours
|
Serum CK measured pre and post exercise
|
From enrollment to the end of treatment at 6 hours
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ERH_2023_3935
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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