NCT06476444

Brief Summary

The aim of this study is to investigate the relationship between physical activity levels, dietary patterns with fat oxidation at rest in normal lean individuals and those with overweight and obese.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

September 1, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2024

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2024

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

June 21, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 26, 2024

Completed
Last Updated

July 1, 2024

Status Verified

June 1, 2024

Enrollment Period

9 months

First QC Date

June 21, 2024

Last Update Submit

June 28, 2024

Conditions

Keywords

MetabolismHealthObesityDietPhysical Activity

Outcome Measures

Primary Outcomes (3)

  • Resting fat oxidation

    In order to determine the relationship of dietary habits and habitual physical activity levels with resting fat oxidation in healthy overweight, obese and normal weight individuals, resting fat oxidation measurements will be performed with a indirect calorimetry (Cardio Pulmonary Exercise Testing, Quark CPET, Italy).All resting fat oxidation tests will be conducted in the same quiet room under a controlled ambient temperature (22-24 °C) and humidity (35-45%). Subjects will be instructed to arrive at the laboratory at 8 a.m. by car or by bus (avoiding any physical activity after waking up) and having fasted for at least 10-12 hours. In addition to this, they will be advised to avoid any moderate physical activity for the 24 h before the test day or any vigorous intensity exercise in the prior 48 h.

    From July 2024 to October 2024

  • The relationship between habitual physical activity level and sedentary behaviour with resting fat oxidation

    Participants' habitual physical activity and sedentary behaviour will be measured with an accelerometer (Actigraph, USA) for 4 consecutive days to determine the relationship with resting fat oxidation.

    July 2024- October 2024

  • Dietary pattern and fat oxidation

    In order to determine the relationship of macronutrient intake and food group consumption with resting fat oxidation, 4-day food consumption records will be obtained from the participants.

    July 2024- October 2024

Study Arms (2)

1. Women with Overweight and Obesity (25.0-34.9 BMI)

Healthy women with overweight and women without any chronic conditions other than obesity In this cross-sectional study, indirect calorimetry will be used to determine resting fat oxidation in these participants. Subsequently, the relationship between the resting fat oxidation data obtained with the habitual diet and physical activity status of these participants will be evaluated. Dietary patterns and physical activity will be assessed with 4 consecutive daily food consumption records and Actigraph GT3X+ devices, respectively.

2. Women with normal weight (18.5-24.9 BMI)

Healthy women with normal weight. In this cross-sectional study, indirect calorimetry will be used to determine resting fat oxidation in these participants. Thus, resting fat oxidation data of healthy women with normal weight and women with obesity/overweight will be compared. Subsequently, the relationship between the resting fat oxidation data obtained with the habitual diet and physical activity status of these participants will be evaluated. Dietary patterns and physical activity will be assessed with 4 consecutive daily food consumption records and Actigraph GT3X+ devices, respectively.

Eligibility Criteria

Age25 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen with overweight and obesity aged 25 to 50.
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Sedentary women aged 25 to 50 with a body mass index range of 18.5-24.9 kg/m2 (normal weight; control group) and 25-34.9 kg/m2 (overweight and obese; research group) will be included in the study.

You may qualify if:

  • Sedentary women aged 25-50 years with a body mass index range of 18.5-24.9 kg/m2 (normal weight) and 25-34.9 kg/m2 (overweight and obese) will be included in the study.

You may not qualify if:

  • Smokers,
  • Taking any medication or supplements that may affect metabolism,
  • Dieting for more than 6 months,
  • Pregnant or breastfeeding,
  • Amenorrhoea,
  • Individuals who meet the physical activity recommendations of the World Health Organisation (at least 150 min of moderate-to-vigorous exercise or at least 75 min of high-intensity exercise per week),
  • Individuals with any chronic disease other than obesity will be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, 06100, Turkey (Türkiye)

Location

Related Publications (2)

  • Fletcher G, Eves FF, Glover EI, Robinson SL, Vernooij CA, Thompson JL, Wallis GA. Dietary intake is independently associated with the maximal capacity for fat oxidation during exercise. Am J Clin Nutr. 2017 Apr;105(4):864-872. doi: 10.3945/ajcn.116.133520. Epub 2017 Mar 1.

  • Jurado-Fasoli L, Amaro-Gahete FJ, Merchan-Ramirez E, Labayen I, Ruiz JR. Relationships between diet and basal fat oxidation and maximal fat oxidation during exercise in sedentary adults. Nutr Metab Cardiovasc Dis. 2021 Apr 9;31(4):1087-1101. doi: 10.1016/j.numecd.2020.11.021. Epub 2020 Dec 1.

MeSH Terms

Conditions

ObesityMotor Activity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Necip Demirci, MSc.

    Hacettepe University

    STUDY CHAIR
  • Muhammed Atakan, Ph.D

    Hacettepe University

    PRINCIPAL INVESTIGATOR
  • Zeynep Ergun, BSc

    Hacettepe University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dietitian

Study Record Dates

First Submitted

June 21, 2024

First Posted

June 26, 2024

Study Start

September 1, 2023

Primary Completion

May 15, 2024

Study Completion

June 10, 2024

Last Updated

July 1, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

I can share my data when requested after the study is published.

Locations