An interventional study of HIIT-AB Group and HIIT-NAB Group in Drinking, Alcohol and Exercise, sponsored by Universidad de Granada. Completed at 1 site in Spain. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-09-06.
Sponsored by Universidad de Granada · Not applicable, Interventional, and Health services research
HIIT-BEER will determine the effect of habitual and moderate beer intake (330-660 ml / day, 5 days / week) on physical fitness, body composition, psychokinetic abilities and psychological status in sedentary healthy adults undergoing a HIIT training program.
Aims:
To determine the effect of habitual and moderate consumption of beer on physical fitness, body composition, psychokinetic and cognitive abilities and psychological status in sedentary healthy adults undergoing a HIIT training program.
The primary hypothesis will that a HIIT program will induce an improvement on physical fitness, body composition, psychokinetic abilities and psychological responses compared to a control group but this positive effect could be blunted by alcohol intake.
Methods:
HIIT-BEER will recruit 80 sedentary, healthy, adults (50% women) aged 18-40 years.
Will be performed a 10-week controlled trial in which the effects of HIIT will be compared to a control group without training. The effects of habitual intake of different alcoholic beverage will be also compared.
After completing the baseline measurements, the selected participants will be randomly assigned to either the control or the exercise training groups. The participants included in the training groups will be asked to choose individual choice about their drinking preference for alcoholic or non-alcoholic beverages. The participants who chose alcohol intake will be randomly assigned into the training group with alcohol beer intake (5.4% Alcohol-Special Alhambra®, Cervezas Alhambra, Spain) or to the sparkling water group with exactly the same amount of distilled alcohol added. The distilled alcoholic beverage used for the investigator's study will be vodka because of the purity of its composition (37.5% ethanol and 62.5% water). The participants who chose non-alcoholic beverages will be randomized into the training groups of non-alcohol beer (0.0% alcohol-Cruzcampo®, Heineken España) or sparkling water (Eliges (IFA) Eliqua 2®, Font Salem, Spain) intakes.
So, eligible participants will be assigned to five groups: (i) a group that will performed HIIT and will consumed 330 ml (women) or 2x300 ml (men) of beer with 5.4% alcohol (HIIT-AB, n=16); (ii) a group that will performed HIIT and will consumed the same amount of beer without alcohol (0.0%) (HIIT-NAB; n=16); (iii) a group that will performed HIIT and will consumed the same amount of sparkling water (0.0%) (HIIT-W; n=16); (iv) a group that will performed HIIT and will consumed sparkling water with the same amount of alcohol than the pre-established beer (5.4%) (HIIT-ASW; n=16); and (v) a control group that will not perform any physical training program (CON; n=16).
The beverage intakes will be programmed from Monday to Friday. There will not specific recommendation for Saturday and Sunday, but the participants will be instructed to keep a moderate alcohol during the weekend.
Laboratory measures completed at baseline and 10 weeks later, include physical fitness (cardiorespiratory fitness, muscular strength), body composition, hearth rate variability (HRV), reaction time, cognitive variables and health-related questionnaires. The investigators will also obtain dietary habits data and cardiovascular disease risk factors.
939 studies on the registry are indexed under Alcohol Drinking; 169 are open to participants now.
This study's enrollment of 80 is below the median of 108 across 813 interventional studies indexed under Alcohol Drinking.
Browse Alcohol Drinking studies →Universidad de Granada is the lead sponsor of 244 studies on the registry; 41 are open to participants now.
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Exclusion Criteria:
No intervention: Control
Intake: 330ml (women) or 2x300 ml (men) of beer with 5.4% alcohol. The beverage intakes will be programmed from Monday to Friday. Training: The volume in HIIT 40-65 min/week at high intensity. HIIT with short intervals. Frequency two times/week. Load variation. Gradual progression to control the exercise dose. Periodization divided in: familiarization phase, phase I, phase II. Sessions. The participants will performed 8 weight-bearing exercises (in circuit form) 2 times/set with an active rest (walking at 6 RPE scale) as many times at as defined. The HIIT intensity will controlled by RPE (0-10 RPE scale). All sessions will be started with a dynamic standardized warm-up, including several muscle activation exercises, and will be ended with a cooling-down protocol.
Other: HIIT-AB Group
Intake: 330 ml (women) or 2x300 ml (men) of beer without alcohol (0.0%). The beverage intakes will be programmed from Monday to Friday. Training: The volume in HIIT 40-65 min/week at high intensity. HIIT with short intervals. Frequency two times/week. Load variation. Gradual progression to control the exercise dose. Periodization divided in: familiarization phase, phase I, phase II. Sessions. The participants will performed 8 weight-bearing exercises (in circuit form) 2 times/set with an active rest (walking at 6 RPE scale) as many times at as defined. The HIIT intensity will controlled by RPE (0-10 RPE scale). All sessions will be started with a dynamic standardized warm-up, including several muscle activation exercises, and will be ended with a cooling-down protocol.
Other: HIIT-NAB Group
Intake: 330 ml (women) or 2x300 ml (men) of sparkling water. The beverage intakes will be programmed from Monday to Friday. Training: The volume in HIIT 40-65 min/week at high intensity. HIIT with short intervals. Frequency two times/week. Load variation. Gradual progression to control the exercise dose. Periodization divided in: familiarization phase, phase I, phase II. Sessions. The participants will performed 8 weight-bearing exercises (in circuit form) 2 times/set with an active rest (walking at 6 RPE scale) as many times at as defined. The HIIT intensity will controlled by RPE (0-10 RPE scale). All sessions will be started with a dynamic standardized warm-up, including several muscle activation exercises, and will be ended with a cooling-down protocol.
Other: HIIT-SW Group
Intake: 330 ml (women) or 2x300 ml (men) of sparkling water with 5.4% alcohol.The beverage intakes will be programmed from Monday to Friday. Training: The volume in HIIT 40-65 min/week at high intensity. HIIT with short intervals. Frequency two times/week. Load variation. Gradual progression to control the exercise dose. Periodization divided in: familiarization phase, phase I, phase II. Sessions. The participants will performed 8 weight-bearing exercises (in circuit form) 2 times/set with an active rest (walking at 6 RPE scale) as many times at as defined. The HIIT intensity will controlled by RPE (0-10 RPE scale). All sessions will be started with a dynamic standardized warm-up, including several muscle activation exercises, and will be ended with a cooling-down protocol.
Other: HIIT-ASW Group
Group that performed HIIT and consumed 330 ml (women) or 2x300 ml (men) of beer with 5.4% alcohol.
Group that performed HIIT and consumed 330 ml (women) or 2x300 ml (men) of beer without alcohol (0.0%).
Group that performed HIIT and consumed the same amount of sparkling water (0.0%).
Group that performed HIIT and consumed sparkling water with the same amount of alcohol than the pre-established beer (5.4%).
Physical Fitness Cardiorespiratory fitness
Cardiorespiratory fitness measure through a maximum treadmill test (VO2 max.).
Time frame: Baseline and through study completion, an average of 10 weeks.
Physical Fitness: Muscular strength (Bosco Test)
Muscle strength measure through: Bosco test.
Time frame: Baseline and through study completion, an average of 10 weeks.
Physical Fitness: Muscular strength (Handgrip strength)
Muscle strength measure through: Handgrip strength.
Time frame: Baseline and through study completion, an average of 10 weeks.
Body composition (DXA)
Body composition measure through: Dual-energy X-ray absorptiometry (DXA).
Time frame: Baseline and through study completion, an average of 10 weeks.
Body composition (Weight)
Body composition measure through: Anthropometry (Weight in kg).
Time frame: Baseline and through study completion, an average of 10 weeks.
Body composition (Height)
Body composition measure through: Anthropometry (Height in meter).
Time frame: Baseline and through study completion, an average of 10 weeks.
Body composition (Hip perimeter)
Body composition measure through: Anthropometry (Hip perimeter in cm)
Time frame: Baseline and through study completion, an average of 10 weeks.
Body composition (Waist circumference)
Body composition measure through: Anthropometry (Waist circumference in cm).
Time frame: Baseline and through study completion, an average of 10 weeks.
Body composition (Neck perimeter)
Body composition measure through: Anthropometry (Neck perimeter in cm).
Time frame: Baseline and through study completion, an average of 10 weeks.
Heart Rate Variability
Measure by Polar RS800CX.
Time frame: Baseline and through study completion, an average of 10 weeks.
Reaction time
Measure by Vienna Test System.
Time frame: Baseline and through study completion, an average of 10 weeks.
Memory
Measure by Spanish-Complutense Verbal Learning Test (TAVEC)
Time frame: Baseline and through study completion, an average of 10 weeks.
Attention
Measure by D2 Test.
Time frame: Baseline and through study completion, an average of 10 weeks.
Working Memory
Measure by Numbers and Letters (WISC-IV).
Time frame: Baseline and through study completion, an average of 10 weeks.
Verbal fluency
Verbal fluency assessment test.
Time frame: Baseline and through study completion, an average of 10 weeks.
Questionnaires and Scales
Measure by: * PREDIMED Questionnaire on Adherence to the Mediterranean Diet. * Beverage Intake Questionnaire (PREDIMED). * Questionnaire of the Five Great Factors of the Personality (BFQ). * Satisfaction with life (SWL). * Health questionnaire (SF-36). * International Fitness Scale Questionnaire (IFIS). * Beck Depression Inventory (BDI-II). * Life Orientation test questionnaire (LOT-R). * Sexual desire questionnaire. * Sexual functioning questionnaire. * Pittsburgh Sleep Quality Index. * Profile of Mood States Questionnaire (POMS). * Scale of Subjective Happiness. * Emotional Intelligence Scale (TMMS). * Scale Panas of positive and negative affect. * Perceived stress scale (PSS). * Scale of assessment of mood (EVEA). * Eating habits questionnaire. * Spanish versión of Three Factor EatingQuestionnaire-R18 (TFEQ-SP) * Scale of regulation of the behavior in physical exercise (BREQ-2). * Scale of measurement of the orientations of goals in the exercise (GOES)
Time frame: Baseline and through study completion, an average of 10 weeks.
Questionnaires and Scales
Measure by: (BDI-II); PREDIMED Questionnaire on Adherence to the Mediterranean Diet ; Sexual desire questionnaire; Sexual functioning questionnaire; Eating habits questionnaire; Beverage Intake Questionnaire (PREDIMED); Perceived stress scale (PSS); Scale of Subjective Happiness; EVEA; IFIS; Pittsburgh Sleep Quality Index; BFQ; LOT-R; PANNAS; POMS; SWLS; TMMS-24 and TFEQ-SP.
Time frame: Every week
Questionaires and Scales
Measure by: PSS; EVEA; PANNAS; TMMS-24
Time frame: Every two weeks
Questionnaires and Scales
Measure by: Scale of Subjective Happiness; Pittsburgh Sleep Quality Index; POMS; BREQ-2 and GOES.
Time frame: Every three weeks
Ran from Jan 2018 to primary completion in May 2018, 4 months.
Of 429 non-industry interventional studies with no phase under Alcohol Drinking, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 46. This study's 4 months is below that.
Counting every sponsor, half of 443 studies reached it within 26 months; a quarter within 11 and three quarters within 46.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.
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