HealthySPCNCT04744064
Soccer Training and Influence of Protein and Carbohydrate Ingestion on Health
A study testing Protein and carbohydrate in people with Healthy, run by University of Copenhagen at 1 site in Denmark.
Trial summary
The aim of the study was to examine the adaptive response to recreational soccer, conducted as small-sided games, and the effect of supplementing with either protein or carbohydrate after each training session in 10 weeks. Read more about this study
- Who is it for?
- Ages 25 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Protein and carbohydrate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 151 participants
- Where
- 1 siteDenmark
- Study dates
- 21 May 2016to 25 Nov 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- age between 25-55 years
- less than two hours of physical training per week over the last two years before entering the study
Who cannot join
- biking for transportation more than 40 km/week
- diagnosed with severe diseases
- medical treatment with a documented effect on body composition
- abuse of alcohol/drugs
- pregnancy or breastfeeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Protein and Carbohydrate Ingestion on Health Related Adaptations to Recreational Soccer - a Randomized Controlled Trial
The aim of the study was to examine the adaptive response to recreational soccer, conducted as small-sided games, and the effect of supplementing with either protein or carbohydrate after each training session in 10 weeks.
One hundred fifty one middle-aged women and men were randomized into a group ingesting protein or carbohydrate beverages immediately after recreational soccer and prior to bedtime on training days or a control group maintained their normal activities. Training was performed 2.1 times per week for 10 weeks.
Read the detailed description
We hypothesized that recreational soccer training followed by protein supplementation would have superior beneficial effects on body composition and health compared to recreational soccer training followed by carbohydrate supplementation. The aim of the present study was to examine the effects of ingesting beverages rich in either protein or carbohydrate during a 10-week recreational soccer training period on the adaptive response of lean body mass (primary outcome parameter), fat mass, bone mass density, fitness and health related blood markers in untrained women and men.
Three-hundred-twenty-nine middle-aged men and women were enrolled. One-hundred-fifty-one meet the inclusion criteria and were randomized to two soccer training groups with supplementation of either protein enriched (PG) or carbohydrate enriched (CG) beverages. Prior to the intervention period forty-four of these subjects (18 women and 26 men) completed testing before and after a 10-week period (CON).
The study was a double-blinded experiment. All subjects in the training groups were offered three training sessions per week. Average attendance were 2.1 sessions per week in both PG and CG. Each session lasted around 1 h and was initiated with low to moderate intensity warming for 10 min followed by small-sided (4v4 up to 7v7) soccer matches with a duration of five min separated by 1-2 min of recovery. The subjects in PG and CG ingested a drink of 250 ml immediately after completion of training sessions and again in the evening before bedtime. Subjects in PG ingested per serving a protein enriched milk-based beverage containing in total 750 KJ, 21.0 g protein (milk protein), 15.0 g carbohydrate, 4.5 g fat. Subjects in CG ingested per serving an isocaloric carbohydrate-rich beverage containing in total 750 KJ, 0 g protein, 0 g fat and 49.2 g carbohydrate (2:1 ratio of maltodextrin: fructose). Before the intervention, the participants completed a weighed dietary record on three consecutive days, including one weekend day. During week five or six in INT, a weighed dietary record was performed on four consecutive days including one weekend day and at least one training day.
Before and after INT, the subjects carried out a performance test battery consisting of a standing long jump, an agility t-test and the Yo-Yo intermittent endurance test level 1 (Yo-Yo IE1) on a grass field. Prior to testing, the subjects refrained from severe physical activity for at least 48 h.
Within five days before and after the start of INT, the subjects arrived to the laboratory after an overnight fasting. Fasting blood samples were drawn from the antecubital vein and analysed for marker of health such as blood glucose and cholesterol. Body composition, including lean body mass (LBM), total fat mass (FM), regional fat mass, bone mineral content (BMC) and bone mineral density (BMD), was assessed by Dual-energy X-ray absorptiometry (DXA)
- Conditions
- Healthy
- Being tested
- Protein and carbohydrate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protein and carbohydrateDietary supplement
Also called Arla Foods Amba, Viby Denmark and Maxim Sports Drink, Orkla Health A/S, Ishøj Denmark
Intake of 2 x 250 ml of either protein (750 KJ, 21.0 g protein (milk protein), 15.0 g carbohydrate, 4.5 g fat ) or carbohydrate ( 750 KJ, 0 g protein, 0 g fat and 49.2 g carbohydrate (2:1 ratio of maltodextrin: fructose))
| Study group | Role | What they receive |
|---|---|---|
| Soccer and protein supplementation | Experimental | Soccer training and post exercise supplementation of protein enriched beverage Receives: Dietary Supplement: Protein and carbohydrate |
| Soccer and carbohydrate supplementation | Experimental | Soccer training and post exercise supplementation of carbohydrate enriched beverage Receives: Dietary Supplement: Protein and carbohydrate |
| Control group | No intervention | A preliminary control group continueing normal lifestyle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lean body mass
Kg
Measured: 10 weeks
Secondary outcomes (2)
Bone density
g/cm2
Measured: 10 weeks
Body fat percentage
% body weight
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2021
- Study start21 May 2016
- Primary completion25 Nov 2016
- Study completion25 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- University of Aarhus
- Responsible party
- Principal investigator, Jonas Tybirk, University of Copenhagen
- Investigators
- Jens Bangsbo, Dr. Sci, Study chair, Department of Nutrition, Exercise and Sports
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04744064
- Sponsor's protocol ID
- Soccer and health
- Acronym
- SPC
- Status last verified
- Feb 2021
- First submitted
- 3 Feb 2021
- Last updated
- 8 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Protein and Carbohydrate Ingestion on Health Related Adaptations to Recreational Soccer - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04744064
- Acronym / sponsor ID
- SPC / Soccer and health
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- University of Aarhus
- Study start
- 21 May 2016 (actual)
- Primary completion
- 25 Nov 2016 (actual)
- Study completion
- 25 Nov 2016 (actual)
- First posted
- 8 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study was to examine the adaptive response to recreational soccer, conducted as small-sided games, and the effect of supplementing with either protein or carbohydrate after each training session in 10 weeks.
One hundred fifty one middle-aged women and men were randomized into a group ingesting protein or carbohydrate beverages immediately after recreational soccer and prior to bedtime on training days or a control group maintained their normal activities. Training was performed 2.1 times per week for 10 weeks.
Detailed description
We hypothesized that recreational soccer training followed by protein supplementation would have superior beneficial effects on body composition and health compared to recreational soccer training followed by carbohydrate supplementation. The aim of the present study was to examine the effects of ingesting beverages rich in either protein or carbohydrate during a 10-week recreational soccer training period on the adaptive response of lean body mass (primary outcome parameter), fat mass, bone mass density, fitness and health related blood markers in untrained women and men.
Three-hundred-twenty-nine middle-aged men and women were enrolled. One-hundred-fifty-one meet the inclusion criteria and were randomized to two soccer training groups with supplementation of either protein enriched (PG) or carbohydrate enriched (CG) beverages. Prior to the intervention period forty-four of these subjects (18 women and 26 men) completed testing before and after a 10-week period (CON).
The study was a double-blinded experiment. All subjects in the training groups were offered three training sessions per week. Average attendance were 2.1 sessions per week in both PG and CG. Each session lasted around 1 h and was initiated with low to moderate intensity warming for 10 min followed by small-sided (4v4 up to 7v7) soccer matches with a duration of five min separated by 1-2 min of recovery. The subjects in PG and CG ingested a drink of 250 ml immediately after completion of training sessions and again in the evening before bedtime. Subjects in PG ingested per serving a protein enriched milk-based beverage containing in total 750 KJ, 21.0 g protein (milk protein), 15.0 g carbohydrate, 4.5 g fat. Subjects in CG ingested per serving an isocaloric carbohydrate-rich beverage containing in total 750 KJ, 0 g protein, 0 g fat and 49.2 g carbohydrate (2:1 ratio of maltodextrin: fructose). Before the intervention, the participants completed a weighed dietary record on three consecutive days, including one weekend day. During week five or six in INT, a weighed dietary record was performed on four consecutive days including one weekend day and at least one training day.
Before and after INT, the subjects carried out a performance test battery consisting of a standing long jump, an agility t-test and the Yo-Yo intermittent endurance test level 1 (Yo-Yo IE1) on a grass field. Prior to testing, the subjects refrained from severe physical activity for at least 48 h.
Within five days before and after the start of INT, the subjects arrived to the laboratory after an overnight fasting. Fasting blood samples were drawn from the antecubital vein and analysed for marker of health such as blood glucose and cholesterol. Body composition, including lean body mass (LBM), total fat mass (FM), regional fat mass, bone mineral content (BMC) and bone mineral density (BMD), was assessed by Dual-energy X-ray absorptiometry (DXA)
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Soccer and protein supplementation | Experimental | Dietary Supplement: Protein and carbohydrateSoccer training and post exercise supplementation of protein enriched beverage |
| Soccer and carbohydrate supplementation | Experimental | Dietary Supplement: Protein and carbohydrateSoccer training and post exercise supplementation of carbohydrate enriched beverage |
| Control group | No intervention | –A preliminary control group continueing normal lifestyle |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- age between 25-55 years
- less than two hours of physical training per week over the last two years before entering the study
Key exclusion criteria (5 listed)
- biking for transportation more than 40 km/week
- diagnosed with severe diseases
- medical treatment with a documented effect on body composition
- abuse of alcohol/drugs
- pregnancy or breastfeeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Protein and carbohydrateAlso: Arla Foods Amba, Viby Denmark and Maxim Sports Drink, Orkla Health A/S, Ishøj DenmarkIntake of 2 x 250 ml of either protein (750 KJ, 21.0 g protein (milk protein), 15.0 g carbohydrate, 4.5 g fat ) or carbohydrate ( 750 KJ, 0 g protein, 0 g fat and 49.2 g carbohydrate (2:1 ratio of maltodextrin: fructose)) | Dietary supplement | Soccer and carbohydrate supplementation, Soccer and protein supplementation |
Primary outcome
Lean body mass
Time frame: 10 weeks
Kg
2 secondary outcomes
Bone density
Time frame: 10 weeks
Body fat percentage
Time frame: 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jens Bangsbo, Dr. Sci study chair
Department of Nutrition, Exercise and Sports
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protein and carbohydrate in people with Healthy, run by University of Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lean body mass (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2021.