NCT03978975

Brief Summary

Aquatic cycling is becoming more popular as it appears to be more suitable for men and women even with poor physical activity level. Commercial tagline highlight beneficial effect of this activity on weight management. However there are poor information concerning the energy response induced by this activity. The aim of this project is to investigate effect of water temperature on energetic response (energy expenditure and food intake) of cycling exercise in water in normal weight and overweight premenopausal women.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 3, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 7, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

September 19, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 19, 2020

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 19, 2022

Completed
Last Updated

September 23, 2019

Status Verified

September 1, 2019

Enrollment Period

1.3 years

First QC Date

June 3, 2019

Last Update Submit

September 20, 2019

Conditions

Keywords

Energy expenditureFood intakeWomenaquacycling

Outcome Measures

Primary Outcomes (4)

  • Food intake during buffet meal 30 minutes after the end of experimental session

    total energy intake at the post session lunch will be calculated by measuring food intake

    Day 7

  • Food intake during buffet meal 30 minutes after the end of experimental session

    total energy intake at the post session lunch will be calculated by measuring food intake

    Day 14

  • Food intake during buffet meal 30 minutes after the end of experimental session

    total energy intake at the post session lunch will be calculated by measuring food intake

    Day 21

  • Food intake during buffet meal 30 minutes after the end of experimental session

    total energy intake at the post session lunch will be calculated by measuring food intake

    Day 28

Secondary Outcomes (12)

  • Appetite, hunger and satiety

    Day 7

  • Appetite, hunger and satiety

    Day 14

  • Appetite, hunger and satiety

    Day 21

  • Appetite, hunger and satiety

    Day 28

  • Energy expenditure

    Day 7

  • +7 more secondary outcomes

Study Arms (2)

normal weight women

ACTIVE COMPARATOR

20 women with a body mass index ranging between 18,5 and 24,9 kg.m2

Behavioral: Food intake

overweight women

EXPERIMENTAL

20 women with a body mass index ranging between 25 and 29,9 kg.m2

Behavioral: Food intake

Interventions

Food intakeBEHAVIORAL

For all those session, subjects will take a standardized breakfast (570kcal) three hours before experimental session. Control session (CON): subject will stand sited without any activity during 40 min. Subjects will be submitted to three aquatic cycling exercise session: * session 27°C :aquatic cycling at 27°C without water jet during 40 min * session 27°C+ water jets : aquatic cycling at 27 °C with water jets during 40 min * session 18°C : aquatic cycling at 187°C without water jet during 40 min Every exercise session will be set at 70% of theorical maximal heart rate During each session, oxygen consumption and carbon dioxide production will be analysed with gas analysis system. Appetite and hunger sensation will be measured with a specific scale at different time point of each day of experimental session. Thirty minutes after the end of each experimental session subjects will have a buffet meal for lunch time.

normal weight womenoverweight women

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Women aged between 20 and 40 years
  • BMI under 25kg.m2 for normal weight women and between 25 and 29,9 kg.m2 for overweight women
  • Daily breakfast
  • Subject which approved informed consent
  • Subject with French medical affiliation

You may not qualify if:

  • Specific medical treatment
  • Aquaphobia
  • Subject under specific diet regimen or weight loss program
  • Subject with cardio-vascular disease
  • Surgical intervention less than 3 months
  • Subject refusing informed and written consent
  • Subject without French medical affiliation
  • subject refusing inscription to the national voluntary list
  • subject smoking or drinking alcohol frequently
  • subject with intense physical activity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63000, France

RECRUITING

MeSH Terms

Conditions

Overweight

Interventions

Eating

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaDigestive System Physiological PhenomenaDigestive System and Oral Physiological Phenomena

Study Officials

  • Martine Duclos

    CHU de Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: participants may receive different interventions sequentially during the protocol
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2019

First Posted

June 7, 2019

Study Start

September 19, 2019

Primary Completion

December 19, 2020

Study Completion

January 19, 2022

Last Updated

September 23, 2019

Record last verified: 2019-09

Locations