Human Metabolic Flexibility: Its Role in Energy Regulation and Obesity

NCT04773132 | Completed

• 1 other identifier: 2014/01182
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

Obesity is commonly described as a consequence of excess calorie intake. Conventionally, the physiological variables that have been of extensive interest are food intake and energy expenditure. Despite decades of research on factors influencing intake and expenditure, to date, no compelling theory has been promulgated to explain why certain humans are more susceptible to weight gain than others. The investigators hypothesize that the measure of an individual's fraction of energy mobilized or deposited as protein (P-ratio), contributes towards an obese morphology and may essentially form a novel approach in understanding the etiology, management and treatment of obesity. In addition, there is a general perception that the consumption of sugar sweetened foods and beverages are one of the major causes of obesity. This study aims to understand metabolic flexibility and the glycemic index of diets in the etiology of obesity. Individual metabolic flexibility may be the key factor that predisposes an individual to obesity. This study is carried out to determine the P-ratio in human subjects.

Conditions

Metabolic Flexibility

Keywords

BMR; P-ratio; Tissue partitioning

Outcome Measures

Primary Outcomes (5)

• Weight

  Kg

  Day 1

• Waist Circumference

  cm

  Day 1

• Hip Circumference

  cm

  Day 1

• Body fat

  Percentage

  Day 1

• Estimated visceral adipose tissue area

  cm2

  Day 1

Secondary Outcomes (1)

• Height

  Day 1

Study Arms (1)

Low Protein Diet

EXPERIMENTAL

All subjects will be given a low protein/protein-free diet in order to deplete the label protein pool. The diet provided will meet the daily energy requirements of all the subjects.

Other: Low Protein

Interventions

Low Protein OTHER

Low protein/protein-free diet for 3 days (Day 1, 2 and Day 3) in order to deplete the label protein pool. The diet provided will meet the daily energy requirements of all the subjects.

Low Protein Diet

Eligibility Criteria

• Age: 21 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Chinese Male or Female
• Age between 21-35 years
• Body mass index 17.5-32.0 kg/m2

You may not qualify if:

• People with major chronic disease such as heart disease, cancer or diabetes mellitus
• People with family history of diabetes
• People who have intolerances or allergies to study foods
• Individuals who are taking drugs known to affect glucose metabolism, body fat distribution, appetite, food intake or energy metabolism
• Individuals who are on a special diet or recently on a weight-lost diet
• Pregnant women

Sponsors & Collaborators

• Singapore Institute of Food and Biotechnology Innovation: lead

Study Sites (1)

Clinical Nutrition Research Centre

Singapore, 117599, Singapore

Location

MeSH Terms

Interventions

Diet, Protein-Restricted

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 18, 2021
• First Posted: February 26, 2021
• Study Start: May 19, 2015
• Primary Completion: April 1, 2016
• Study Completion: December 11, 2017
• Last Updated: February 26, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)