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Beer or Ethanol Effects on the Response to High Intensity Interval Training: A Controlled Study in Healthy Individuals (BEER-HIIT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03660579
Recruitment Status : Completed
First Posted : September 6, 2018
Last Update Posted : September 6, 2018
Sponsor:
Information provided by (Responsible Party):
Manuel Castillo Garzón, Universidad de Granada

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Drinking, Alcohol Exercise Other: HIIT-AB Group Other: HIIT-NAB Group Other: HIIT-SW Group Other: HIIT-ASW Group Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Beer or Ethanol Effects on the Response to High Intensity Interval Training: A Controlled Study in Healthy Individuals: BEER - HIIT Study
Actual Study Start Date : January 20, 2018
Actual Primary Completion Date : May 20, 2018
Actual Study Completion Date : June 1, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: HIIT-CON
No intervention: Control
Experimental: HIIT-AB Group

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
Group that performed HIIT and consumed 330 ml (women) or 2x300 ml (men) of beer with 5.4% alcohol.

Experimental: HIIT-NAB 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
Group that performed HIIT and consumed 330 ml (women) or 2x300 ml (men) of beer without alcohol (0.0%).

Experimental: HIIT-SW 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
Group that performed HIIT and consumed the same amount of sparkling water (0.0%).

Experimental: HIIT-ASW 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 sparkling water with the same amount of alcohol than the pre-established beer (5.4%).




Primary Outcome Measures :
  1. Physical Fitness Cardiorespiratory fitness [ Time Frame: Baseline and through study completion, an average of 10 weeks. ]
    Cardiorespiratory fitness measure through a maximum treadmill test (VO2 max.).


Secondary Outcome Measures :
  1. Physical Fitness: Muscular strength (Bosco Test) [ Time Frame: Baseline and through study completion, an average of 10 weeks. ]
    Muscle strength measure through: Bosco test.

  2. Physical Fitness: Muscular strength (Handgrip strength) [ Time Frame: Baseline and through study completion, an average of 10 weeks. ]
    Muscle strength measure through: Handgrip strength.

  3. Body composition (DXA) [ Time Frame: Baseline and through study completion, an average of 10 weeks. ]
    Body composition measure through: Dual-energy X-ray absorptiometry (DXA).

  4. Body composition (Weight) [ Time Frame: Baseline and through study completion, an average of 10 weeks. ]
    Body composition measure through: Anthropometry (Weight in kg).

  5. Body composition (Height) [ Time Frame: Baseline and through study completion, an average of 10 weeks. ]
    Body composition measure through: Anthropometry (Height in meter).

  6. Body composition (Hip perimeter) [ Time Frame: Baseline and through study completion, an average of 10 weeks. ]
    Body composition measure through: Anthropometry (Hip perimeter in cm)

  7. Body composition (Waist circumference) [ Time Frame: Baseline and through study completion, an average of 10 weeks. ]
    Body composition measure through: Anthropometry (Waist circumference in cm).

  8. Body composition (Neck perimeter) [ Time Frame: Baseline and through study completion, an average of 10 weeks. ]
    Body composition measure through: Anthropometry (Neck perimeter in cm).

  9. Heart Rate Variability [ Time Frame: Baseline and through study completion, an average of 10 weeks. ]
    Measure by Polar RS800CX.

  10. Reaction time [ Time Frame: Baseline and through study completion, an average of 10 weeks. ]
    Measure by Vienna Test System.

  11. Memory [ Time Frame: Baseline and through study completion, an average of 10 weeks. ]
    Measure by Spanish-Complutense Verbal Learning Test (TAVEC)

  12. Attention [ Time Frame: Baseline and through study completion, an average of 10 weeks. ]
    Measure by D2 Test.

  13. Working Memory [ Time Frame: Baseline and through study completion, an average of 10 weeks. ]
    Measure by Numbers and Letters (WISC-IV).

  14. Verbal fluency [ Time Frame: Baseline and through study completion, an average of 10 weeks. ]
    Verbal fluency assessment test.

  15. Questionnaires and Scales [ Time Frame: Baseline and through study completion, an average of 10 weeks. ]

    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)

  16. Questionnaires and Scales [ Time Frame: Every week ]

    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.


  17. Questionaires and Scales [ Time Frame: Every two weeks ]

    Measure by:

    PSS; EVEA; PANNAS; TMMS-24


  18. Questionnaires and Scales [ Time Frame: Every three weeks ]

    Measure by:

    Scale of Subjective Happiness; Pittsburgh Sleep Quality Index; POMS; BREQ-2 and GOES.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age: 18-40 years
  • BMI:18.5-25 kg/m2
  • Not engaged in regular physical activity >20min on >3days/week
  • Not participating in a weight loss programme
  • Stable weight over the last 5 months (body weight changes>5kg)
  • Participant must be capable and willing to provide consent, understand exclusion criteria and accept the randomized group assignment
  • Normal electrocardiogram
  • Not personal family history related to alcohol consumption.

Exclusion Criteria:

  • History of cardiovascular disease
  • Diabetes
  • Pregnancy or planning to get pregnant during study period
  • Beta blockers or benzodiapezins use
  • Taking medication for thyroid
  • Other significant conditions that are life-threatening or that can interfere with or be aggravated by exercise
  • Unwillingness to either complete the study requirements or to be randomized into control or training group

Information from the National Library of Medicine

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): NCT03660579


Locations
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Spain
Universidad de Granada
Granada, Andalucia, Spain, 18071
Sponsors and Collaborators
Universidad de Granada
Investigators
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Principal Investigator: Manuel J. Castillo Garzón Universidad de Granada
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Manuel Castillo Garzón, University Professor, Universidad de Granada
ClinicalTrials.gov Identifier: NCT03660579    
Other Study ID Numbers: 321/CEIH/2017
First Posted: September 6, 2018    Key Record Dates
Last Update Posted: September 6, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Manuel Castillo Garzón, Universidad de Granada:
Physical fitness
Recovery
Stress
Training
HIIT
Beer
Additional relevant MeSH terms:
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Alcohol Drinking
Drinking Behavior