Physical Activity, Meal Composition, and RMR Among Children Adolescent and Adults

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Other: DRINK - Water, Protein, Fat, Carbohydrate

• Registration Number: NCT04284683
• Lead Sponsor: Meir Medical Center

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.

Detailed Description

One hundred (100) healthy volunteers, 50 normal weight (NW) and 50 overweight (OW), age 6-30 will be recruited for the current study. All participants and/or their parents will sign informed consent prior to their participation. Participants will visit the clinic 4 times, with a week's difference between them. Participants will arrive at the clinic after 12 hours of fasting and avoiding physical activity for 14 hours. During the first visit, their RMR will be measured, and 15min later they will perform 60 min of aerobic training, and 15 minutes later they will be asked to drink 300ml of water, followed by a second RMR test. In the consecutive visits they will follow the same routine without the first RMR test, and drink either carbohydrate enriched shake, protein enriched shake or fat enriched shake; in a random order.

Study Timeline

• Study Start: 2019-03-01
• Study First Submitted: 2019-03-17
• Study First Submitted QC: 2020-02-23
• Study First Posted: 2020-02-26
• Status Verified: 2020-09
• Primary Completion: 2020-09-29
• Study Completion: 2020-09-29
• Last Update Submitted: 2020-09-29
• Last Update Posted: 2020-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Normal and overweight participants	DRINK - Water, Protein, Fat, Carbohydrate	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.

Primary Outcome Measures

Name	Time	Method
Change in RMR from baseline	Through study completion, an average of 6 weeks (during 4 visits)	Resting Metabolic Rate

Trial Locations

Locations (2)

Meir Medical Center; 🇮🇱 Kfar Saba, Israel

'Meir children's sport and health center'; 🇮🇱 Kfar-Saba, Israel