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

September 4, 2018 updated by: Manuel Castillo Garzón, Universidad de Granada

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

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Andalucia
      • Granada, Andalucia, Spain, 18071
        • Universidad de Granada

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

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.

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.

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.

Group that performed HIIT and consumed sparkling water with the same amount of alcohol than the pre-established beer (5.4%).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.).
Baseline and through study completion, an average of 10 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical Fitness: Muscular strength (Bosco Test)
Time Frame: Baseline and through study completion, an average of 10 weeks.
Muscle strength measure through: Bosco test.
Baseline and through study completion, an average of 10 weeks.
Physical Fitness: Muscular strength (Handgrip strength)
Time Frame: Baseline and through study completion, an average of 10 weeks.
Muscle strength measure through: Handgrip strength.
Baseline and through study completion, an average of 10 weeks.
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).
Baseline and through study completion, an average of 10 weeks.
Body composition (Weight)
Time Frame: Baseline and through study completion, an average of 10 weeks.
Body composition measure through: Anthropometry (Weight in kg).
Baseline and through study completion, an average of 10 weeks.
Body composition (Height)
Time Frame: Baseline and through study completion, an average of 10 weeks.
Body composition measure through: Anthropometry (Height in meter).
Baseline and through study completion, an average of 10 weeks.
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)
Baseline and through study completion, an average of 10 weeks.
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).
Baseline and through study completion, an average of 10 weeks.
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).
Baseline and through study completion, an average of 10 weeks.
Heart Rate Variability
Time Frame: Baseline and through study completion, an average of 10 weeks.
Measure by Polar RS800CX.
Baseline and through study completion, an average of 10 weeks.
Reaction time
Time Frame: Baseline and through study completion, an average of 10 weeks.
Measure by Vienna Test System.
Baseline and through study completion, an average of 10 weeks.
Memory
Time Frame: Baseline and through study completion, an average of 10 weeks.
Measure by Spanish-Complutense Verbal Learning Test (TAVEC)
Baseline and through study completion, an average of 10 weeks.
Attention
Time Frame: Baseline and through study completion, an average of 10 weeks.
Measure by D2 Test.
Baseline and through study completion, an average of 10 weeks.
Working Memory
Time Frame: Baseline and through study completion, an average of 10 weeks.
Measure by Numbers and Letters (WISC-IV).
Baseline and through study completion, an average of 10 weeks.
Verbal fluency
Time Frame: Baseline and through study completion, an average of 10 weeks.
Verbal fluency assessment test.
Baseline and through study completion, an average of 10 weeks.
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)
Baseline and through study completion, an average of 10 weeks.
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.

Every week
Questionaires and Scales
Time Frame: Every two weeks

Measure by:

PSS; EVEA; PANNAS; TMMS-24

Every two weeks
Questionnaires and Scales
Time Frame: Every three weeks

Measure by:

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

Every three weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Manuel J. Castillo Garzón, Universidad de Granada

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2018

Primary Completion (Actual)

May 20, 2018

Study Completion (Actual)

June 1, 2018

Study Registration Dates

First Submitted

July 20, 2018

First Submitted That Met QC Criteria

September 4, 2018

First Posted (Actual)

September 6, 2018

Study Record Updates

Last Update Posted (Actual)

September 6, 2018

Last Update Submitted That Met QC Criteria

September 4, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 321/CEIH/2017

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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