Fitness Study 2020

NCT04392752 | Unknown DMC

• 1 other identifier: fitnessjyvaskyla
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The experimental participant group (n=15+15) includes male and female fitness athletes during their \~25 week competition preparation in fall 2019 for the Finnish national championships. Participants must have at least two years of goal-oriented gym training and their health status will be determined before measurements via an online pre-study questionnaire. The control group (n=15+15) will maintain their normal training and diet without competing during the study period. Otherwise, the control group is matched with the athletic group based on age, height, weight and training experience. Participants selected for the study will complete an additional questionnaire to be reviewed by the study physician to confirm that participants meet the health status inclusion criteria. This study includes four laboratory testing sessions over the 50-week period. Time points include testing before the diet or the control period start (PRE), one week before the competition (MID), after the competition (COMP) and after a recovery period (POST). During COMP-POST the participants are advised to continue training, but to stop competition dieting."Measurements will include body composition (fat mass and fat free mass by bioimpedance, DXA and skinfolds), resting metabolic rate (indirect calorimetry), vastus lateralis and triceps brachii muscle-cross sectional area, subcutaneous fat thickness from ultrasonography and circulating hormone analysis. Also, whole blood will be analyzed for hemoglobin and hematocrit and systems biology approach: e.g. serum metabolome and possibly also other analysis. Lower body maximal voluntary isometric force will be measured via knee extension machine device. Average weekly physical activity will be determined with a wrist-worn uni-axial accelerometer. Training and dietary data (nutrient intake, volume, intensity etc.) will be collected via nutrition and training diaries. Psychological questionnaires will be conducted via an online survey.

Conditions

Weight Reduction; Diet; Deficiency

Outcome Measures

Primary Outcomes (1)

• Change in body composition during the competition preparation and after the recovery period

  Fat mass (kg) will be estimated by Dual-energy X-ray absorptiometry (DXA, Lunar Prodigy Advance, GE Medical Systems-Lunar, Madison WI USA) using methods similar to Hulmi et al. (2015; 2017) in a fasted state. The analysis (using enCORE 2005, version 9.30 and Advance 12.30) will provide total fat mass (kg). There will be 3 measurements.

  (-25 week, -1 week, +1-day, +25 week)

Secondary Outcomes (6)

• Change in physical performance during the competition preparation and after the recovery period

  (-25 week, -1 week, +25 week)

• Change in physical activity and training diaries during the competition preparation and after the recovery period

  -25-week, -20-wee, 16-week, -12-week, -8-week, -4-week, -1week, +1-week +4-week, +8-wee, +12-week, +16-week, +20-week, +25-week

• Change in resting metabolic rate during the competition preparation and after the recovery period

  (-25 week, -1 week, +25 week)

• Change in different omics in during the competition preparation and after the recovery period

  (-25 week, -1 week, +1-day, +25 week)

• Chance in muscle subcutaneuous fat thickness in vastus lateralis muscle during the competition preparation and after the recovery period

  (-25 week, -1 week, +1-day, +25 week)

Study Arms (2)

Participants

EXPERIMENTAL

The participants are recruited via the University of Jyväskylä and Finnish Fitness Sports Association web page and social media channels. An online pre-study questionnaire are sent to randomly chosen athletes and control group candidates who claim to fulfill the inclusion criteria and volunteer for the study. The participants selected for the study filled an additional questionnaire which is subsequently reviewed by the physician of the study to confirm that they will meet inclusion criteria relating to health.

Other: Dieting intervention

Control

NO INTERVENTION

The target is 15 male ja 15 female participants for both the control and intervention groups. To be included, participants need to be with two or more years of resistance training experience, similar to our previous study in females (Hulmi et al. 2017). If more than 15+15 control participants sign up for the study, the final group will be matched to the intervention group based on age, height, weight, and training experience reported on the pre-study questionnaire. The control group maintain their normal nutrition and training during the study.

Interventions

Dieting intervention OTHER

This study includes four laboratory testing sessions over the 50-week period. Testing sessions will be performed over one week. Time points include testing before the diet or the control period start (PRE), one week before the competition (MID), after the competition (COMP) and after a recovery period (POST), during which the participants are advised to continue their normal training regimen, but to stop competition dieting. Participants will spend three hours in the laboratory between 0700-1300. The control group will be advised to maintain their normal physical activity diet throughout the study. The participants will be given identification numbers and the research group is blinded so that they do not know which group participants belong to. All measurements will be conducted at the same time (always within max ±1 hour) due to the importance of standardizing the time of the day of measurements.

Participants

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• two or more years of resistance training experience,
• participants must be 22-40 years old
• No 3 shiftwork
• Participants must be preparing for the Finnish Fitness Sports Association's national championships 2019 in the bodybuilding or men's or women´s divisions to be eligible intervention group.

You may not qualify if:

• diagnosed with chronic diseases
• prescribed medications
• using performance-enhancing drugs
• competing in the bodybuilding or men's fitness divisions autumn 2019 or 2020
• competing junior or master categories
• competing at non-drug tested competitions

Sponsors & Collaborators

• University of Jyvaskyla: lead
• Finnish Institute for Health and Welfare: collaborator

Study Sites (1)

University of Jyväskylä

Jyväskylä, 40014, Finland

Location

Related Publications (3)

• Hulmi JJ, Isola V, Suonpaa M, Jarvinen NJ, Kokkonen M, Wennerstrom A, Nyman K, Perola M, Ahtiainen JP, Hakkinen K. The Effects of Intensive Weight Reduction on Body Composition and Serum Hormones in Female Fitness Competitors. Front Physiol. 2017 Jan 10;7:689. doi: 10.3389/fphys.2016.00689. eCollection 2016.

  PMID: 28119632 BACKGROUND

• Mikkonen R, Hackney AC, Hulmi J, Isola V, Ahtiainen J, Ihalainen J. Hormone Profiles After Planned Low Energy Availability Exposure in Naturally Menstruating and Hormonal Contraceptive Using Physique Athletes. Eur J Sport Sci. 2025 Dec;25(12):e70076. doi: 10.1002/ejsc.70076.

  PMID: 41235908 DERIVED

• Isola V, Hulmi JJ, Petaja P, Helms ER, Karppinen JE, Ahtiainen JP. Weight loss induces changes in adaptive thermogenesis in female and male physique athletes. Appl Physiol Nutr Metab. 2023 Apr 1;48(4):307-320. doi: 10.1139/apnm-2022-0372. Epub 2023 Jan 16.

  PMID: 36645885 DERIVED

MeSH Terms

Conditions

Weight Loss; Malnutrition

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Juha P Ahtiainen, PhD

  Faculty od Sport and Health Sciences, University of Jyväskylä, Finland

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Investigator

Model Details: This study includes four laboratory testing sessions over the 50-week period. Testing sessions will be performed over one week. Time points include testing before the diet or the control period start (PRE), one week before the competition (MID), after the competition (COMP) and after a recovery period (POST), during which the participants are advised to continue their normal training regimen, but to stop competition dieting. Participants will spend three hours in the laboratory between 0700-1300. The control group will be advised to maintain their normal physical activity diet throughout the study. The participants will be given identification numbers and the research group is blinded so that they do not know which group participants belong to. All measurements will be conducted at the same time (always within max ±1 hour) due to the importance of standardizing the time of the day of measurements.

Study Record Dates

• First Submitted: September 25, 2019
• First Posted: May 19, 2020
• Study Start: February 2, 2019
• Primary Completion: June 1, 2020
• Study Completion: August 1, 2020
• Last Updated: May 19, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)