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

Exercise Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03660579
• Other study ID #: 321/CEIH/2017
• Status: Completed
• Phase: N/A
• Start date: January 20, 2018
• Est. completion date: June 1, 2018

Study information

• Verified date: September 2018
• Source: Universidad de Granada
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 1, 2018
• Est. primary completion date: May 20, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Drinking
• Drinking, Alcohol
• Exercise

Intervention

Other:
• HIIT-AB Group
Group that performed HIIT and consumed 330 ml (women) or 2x300 ml (men) of beer with 5.4% alcohol.
• HIIT-NAB Group
Group that performed HIIT and consumed 330 ml (women) or 2x300 ml (men) of beer without alcohol (0.0%).
• HIIT-SW Group
Group that performed HIIT and consumed the same amount of sparkling water (0.0%).
• HIIT-ASW Group
Group that performed HIIT and consumed sparkling water with the same amount of alcohol than the pre-established beer (5.4%).

Locations

Country	Name	City	State
Spain	Universidad de Granada	Granada	Andalucia

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Granada

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical Fitness Cardiorespiratory fitness	Cardiorespiratory fitness measure through a maximum treadmill test (VO2 max.).	Baseline and through study completion, an average of 10 weeks.
Secondary	Physical Fitness: Muscular strength (Bosco Test)	Muscle strength measure through: Bosco test.	Baseline and through study completion, an average of 10 weeks.
Secondary	Physical Fitness: Muscular strength (Handgrip strength)	Muscle strength measure through: Handgrip strength.	Baseline and through study completion, an average of 10 weeks.
Secondary	Body composition (DXA)	Body composition measure through: Dual-energy X-ray absorptiometry (DXA).	Baseline and through study completion, an average of 10 weeks.
Secondary	Body composition (Weight)	Body composition measure through: Anthropometry (Weight in kg).	Baseline and through study completion, an average of 10 weeks.
Secondary	Body composition (Height)	Body composition measure through: Anthropometry (Height in meter).	Baseline and through study completion, an average of 10 weeks.
Secondary	Body composition (Hip perimeter)	Body composition measure through: Anthropometry (Hip perimeter in cm)	Baseline and through study completion, an average of 10 weeks.
Secondary	Body composition (Waist circumference)	Body composition measure through: Anthropometry (Waist circumference in cm).	Baseline and through study completion, an average of 10 weeks.
Secondary	Body composition (Neck perimeter)	Body composition measure through: Anthropometry (Neck perimeter in cm).	Baseline and through study completion, an average of 10 weeks.
Secondary	Heart Rate Variability	Measure by Polar RS800CX.	Baseline and through study completion, an average of 10 weeks.
Secondary	Reaction time	Measure by Vienna Test System.	Baseline and through study completion, an average of 10 weeks.
Secondary	Memory	Measure by Spanish-Complutense Verbal Learning Test (TAVEC)	Baseline and through study completion, an average of 10 weeks.
Secondary	Attention	Measure by D2 Test.	Baseline and through study completion, an average of 10 weeks.
Secondary	Working Memory	Measure by Numbers and Letters (WISC-IV).	Baseline and through study completion, an average of 10 weeks.
Secondary	Verbal fluency	Verbal fluency assessment test.	Baseline and through study completion, an average of 10 weeks.
Secondary	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)	Baseline and through study completion, an average of 10 weeks.
Secondary	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.	Every week
Secondary	Questionaires and Scales	Measure by: PSS; EVEA; PANNAS; TMMS-24	Every two weeks
Secondary	Questionnaires and Scales	Measure by: Scale of Subjective Happiness; Pittsburgh Sleep Quality Index; POMS; BREQ-2 and GOES.	Every three weeks