NCT04284683

Brief Summary

Resting metabolic rate (RMR) is the amount of energy the body uses at rest, and accounts for 60%-70% of daily energy expenditure. Although measured at rest, RMR is strongly influenced by physical activity because the increased metabolic rate during exercise is partially carried over even when exercise stops. Therefore, persons who are physically active maintain higher RMR and less body fat than do sedentary controls. It is well known that high energy intake stimulates whereas caloric restriction reduces RMR. Food thermogenesis corresponds to approximately 10% of daily energy expenditure. Diet-induced thermogenesis is greater on a high protein and carbohydrate diet than on a fat diet. Other factors the affect RMR are age (RMR tends to decline progressively over the life span) and body composition (lean body mass is regarded as the main determinant of RMR). However, the research regarding the effect of a specific combination of macronutrients and exercise on RMR is scarce. Therefore, the aim of the current study is to assess the combined effect of a meal composition and physical activity on RMR in normal weight and overweight children, adolescents and adults.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Mar 2019

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2019

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

March 17, 2019

Completed
12 months until next milestone

First Posted

Study publicly available on registry

February 26, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 29, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 29, 2020

Completed
Last Updated

September 30, 2020

Status Verified

September 1, 2020

Enrollment Period

1.6 years

First QC Date

March 17, 2019

Last Update Submit

September 29, 2020

Conditions

Keywords

RMRMacro nutrientsExercise

Outcome Measures

Primary Outcomes (1)

  • Change in RMR from baseline

    Resting Metabolic Rate

    Through study completion, an average of 6 weeks (during 4 visits)

Study Arms (1)

Normal and overweight participants

EXPERIMENTAL

Healthy males and female, age 6 to 30. BMI range for participants age 6 to 18 is between 5th percentile to 85th percentile, overweight BMI between the 85 and 95th percentile, and obese, above the 95th percentile. BMI range for participants age 18 to 30 is between 18.5 to 24.9 for normal weight, 25-30 for overweight and above 30 for obese.

Other: DRINK - Water, Protein, Fat, Carbohydrate

Interventions

Following exercise participants will consume a drink (with different composition in each visit) and than RMR will be evaluated.

Normal and overweight participants

Eligibility Criteria

Age6 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Ages 6-30 years.
  • Normal weight and over weight participants

You may not qualify if:

  • Elite athletes
  • Participants with physical limitations concerning strenuous physical activity.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

'Meir children's sport and health center'

Kfar Saba, 44281, Israel

Location

Meir Medical Center

Kfar Saba, 44281, Israel

Location

MeSH Terms

Conditions

ObesityMotor Activity

Interventions

ProteinsCD36 AntigensCarbohydrates

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and ProteinsPlatelet Membrane GlycoproteinsMembrane GlycoproteinsGlycoproteinsGlycoconjugatesFatty Acid Transport ProteinsMembrane Transport ProteinsCarrier ProteinsMembrane ProteinsReceptors, Cell SurfaceReceptors, ImmunologicScavenger Receptors, Class BReceptors, ScavengerReceptors, LDLReceptors, Lipoprotein

Study Officials

  • Dan Nemet, MD

    Meir Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dan Nemet

Study Record Dates

First Submitted

March 17, 2019

First Posted

February 26, 2020

Study Start

March 1, 2019

Primary Completion

September 29, 2020

Study Completion

September 29, 2020

Last Updated

September 30, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations