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

Primary Purpose

Drinking, Alcohol, Exercise

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
HIIT-AB Group
HIIT-NAB Group
HIIT-SW Group
HIIT-ASW Group
Sponsored by
Universidad de Granada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Drinking, Alcohol focused on measuring Physical fitness, Recovery, Stress, Training, HIIT, Beer

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Universidad de Granada

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

No Intervention

Experimental

Experimental

Experimental

Experimental

Arm Label

HIIT-CON

HIIT-AB Group

HIIT-NAB Group

HIIT-SW Group

HIIT-ASW Group

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Physical Fitness Cardiorespiratory fitness
Cardiorespiratory fitness measure through a maximum treadmill test (VO2 max.).

Secondary Outcome Measures

Physical Fitness: Muscular strength (Bosco Test)
Muscle strength measure through: Bosco test.
Physical Fitness: Muscular strength (Handgrip strength)
Muscle strength measure through: Handgrip strength.
Body composition (DXA)
Body composition measure through: Dual-energy X-ray absorptiometry (DXA).
Body composition (Weight)
Body composition measure through: Anthropometry (Weight in kg).
Body composition (Height)
Body composition measure through: Anthropometry (Height in meter).
Body composition (Hip perimeter)
Body composition measure through: Anthropometry (Hip perimeter in cm)
Body composition (Waist circumference)
Body composition measure through: Anthropometry (Waist circumference in cm).
Body composition (Neck perimeter)
Body composition measure through: Anthropometry (Neck perimeter in cm).
Heart Rate Variability
Measure by Polar RS800CX.
Reaction time
Measure by Vienna Test System.
Memory
Measure by Spanish-Complutense Verbal Learning Test (TAVEC)
Attention
Measure by D2 Test.
Working Memory
Measure by Numbers and Letters (WISC-IV).
Verbal fluency
Verbal fluency assessment test.
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)
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.
Questionaires and Scales
Measure by: PSS; EVEA; PANNAS; TMMS-24
Questionnaires and Scales
Measure by: Scale of Subjective Happiness; Pittsburgh Sleep Quality Index; POMS; BREQ-2 and GOES.

Full Information

First Posted
July 20, 2018
Last Updated
September 4, 2018
Sponsor
Universidad de Granada
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1. Study Identification

Unique Protocol Identification Number
NCT03660579
Brief Title
Beer or Ethanol Effects on the Response to High Intensity Interval Training: A Controlled Study in Healthy Individuals
Acronym
BEER-HIIT
Official Title
Beer or Ethanol Effects on the Response to High Intensity Interval Training: A Controlled Study in Healthy Individuals: BEER - HIIT Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
January 20, 2018 (Actual)
Primary Completion Date
May 20, 2018 (Actual)
Study Completion Date
June 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Granada

4. Oversight

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

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drinking, Alcohol, Exercise
Keywords
Physical fitness, Recovery, Stress, Training, HIIT, Beer

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HIIT-CON
Arm Type
No Intervention
Arm Description
No intervention: Control
Arm Title
HIIT-AB Group
Arm Type
Experimental
Arm Description
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.
Arm Title
HIIT-NAB Group
Arm Type
Experimental
Arm Description
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.
Arm Title
HIIT-SW Group
Arm Type
Experimental
Arm Description
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.
Arm Title
HIIT-ASW Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
HIIT-AB Group
Intervention Description
Group that performed HIIT and consumed 330 ml (women) or 2x300 ml (men) of beer with 5.4% alcohol.
Intervention Type
Other
Intervention Name(s)
HIIT-NAB Group
Intervention Description
Group that performed HIIT and consumed 330 ml (women) or 2x300 ml (men) of beer without alcohol (0.0%).
Intervention Type
Other
Intervention Name(s)
HIIT-SW Group
Intervention Description
Group that performed HIIT and consumed the same amount of sparkling water (0.0%).
Intervention Type
Other
Intervention Name(s)
HIIT-ASW Group
Intervention Description
Group that performed HIIT and consumed sparkling water with the same amount of alcohol than the pre-established beer (5.4%).
Primary Outcome Measure Information:
Title
Physical Fitness Cardiorespiratory fitness
Description
Cardiorespiratory fitness measure through a maximum treadmill test (VO2 max.).
Time Frame
Baseline and through study completion, an average of 10 weeks.
Secondary Outcome Measure Information:
Title
Physical Fitness: Muscular strength (Bosco Test)
Description
Muscle strength measure through: Bosco test.
Time Frame
Baseline and through study completion, an average of 10 weeks.
Title
Physical Fitness: Muscular strength (Handgrip strength)
Description
Muscle strength measure through: Handgrip strength.
Time Frame
Baseline and through study completion, an average of 10 weeks.
Title
Body composition (DXA)
Description
Body composition measure through: Dual-energy X-ray absorptiometry (DXA).
Time Frame
Baseline and through study completion, an average of 10 weeks.
Title
Body composition (Weight)
Description
Body composition measure through: Anthropometry (Weight in kg).
Time Frame
Baseline and through study completion, an average of 10 weeks.
Title
Body composition (Height)
Description
Body composition measure through: Anthropometry (Height in meter).
Time Frame
Baseline and through study completion, an average of 10 weeks.
Title
Body composition (Hip perimeter)
Description
Body composition measure through: Anthropometry (Hip perimeter in cm)
Time Frame
Baseline and through study completion, an average of 10 weeks.
Title
Body composition (Waist circumference)
Description
Body composition measure through: Anthropometry (Waist circumference in cm).
Time Frame
Baseline and through study completion, an average of 10 weeks.
Title
Body composition (Neck perimeter)
Description
Body composition measure through: Anthropometry (Neck perimeter in cm).
Time Frame
Baseline and through study completion, an average of 10 weeks.
Title
Heart Rate Variability
Description
Measure by Polar RS800CX.
Time Frame
Baseline and through study completion, an average of 10 weeks.
Title
Reaction time
Description
Measure by Vienna Test System.
Time Frame
Baseline and through study completion, an average of 10 weeks.
Title
Memory
Description
Measure by Spanish-Complutense Verbal Learning Test (TAVEC)
Time Frame
Baseline and through study completion, an average of 10 weeks.
Title
Attention
Description
Measure by D2 Test.
Time Frame
Baseline and through study completion, an average of 10 weeks.
Title
Working Memory
Description
Measure by Numbers and Letters (WISC-IV).
Time Frame
Baseline and through study completion, an average of 10 weeks.
Title
Verbal fluency
Description
Verbal fluency assessment test.
Time Frame
Baseline and through study completion, an average of 10 weeks.
Title
Questionnaires and Scales
Description
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.
Title
Questionnaires and Scales
Description
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
Title
Questionaires and Scales
Description
Measure by: PSS; EVEA; PANNAS; TMMS-24
Time Frame
Every two weeks
Title
Questionnaires and Scales
Description
Measure by: Scale of Subjective Happiness; Pittsburgh Sleep Quality Index; POMS; BREQ-2 and GOES.
Time Frame
Every three weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manuel J. Castillo Garzón
Organizational Affiliation
Universidad de Granada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidad de Granada
City
Granada
State/Province
Andalucia
ZIP/Postal Code
18071
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
32460793
Citation
Molina-Hidalgo C, De-la-O A, Dote-Montero M, Amaro-Gahete FJ, Castillo MJ. Influence of daily beer or ethanol consumption on physical fitness in response to a high-intensity interval training program. The BEER-HIIT study. J Int Soc Sports Nutr. 2020 May 27;17(1):29. doi: 10.1186/s12970-020-00356-7.
Results Reference
derived

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Beer or Ethanol Effects on the Response to High Intensity Interval Training: A Controlled Study in Healthy Individuals

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