The Effect of Phosphorus on Diet Induced Thermogenesis | NCT02594787

Studies
The Effect of Phosphorus on Diet Induced Thermogenesis

NCT02594787

Sponsor

Lebanese American University

Status

Completed

Last Update Posted

Nov 3, 2015Estimated

Enrollment

23Actual

Phase

Not Applicable

Conditions

Imbalance of Constituents of Food Intake
Healthy

Interventions

Phosphorus
Placebo

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2011

Primary Completion Date

Jan 2014Actual

Completion Date

Jan 2014Actual

First Submitted Date

Nov 1, 2015

First Submission Date that Met QC Criteria

Nov 2, 2015

First Posted Date

Nov 3, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 2, 2015

Last Update Posted Date

Nov 3, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of the trial is to investigate the effect of ingestion of 75g of glucose (with or without phosphorus) on diet induced thermogenesis (using indirect calorimetry) and appetite (using visual analogue scales) in lean and obese healthy subjects

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

23Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Phosphorus	Active Comparator	Intervention (500 mg of potassium phosphate) will be administered with 75 g glucose solution and diet induced thermogenesis will be measured afterwards	Dietary Supplement: Phosphorus
Placebo	Placebo Comparator	Placebo (cellulose) will be administered with 75 g glucose solution and diet induced thermogenesis will be measured afterwards	Dietary Supplement: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Phosphorus	Dietary Supplement		Phosphorus
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Diet Induced Thermogenesis	Diet Induced Thermogenesis will be measured using indirect calorimetry (VO2 consumption)	180 minutes (measured every 30 min)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy
Sedentary lifestyle
Stable weight for the past 3 months
On a balanced diet

Exclusion Criteria:

Underweight (BMI<18.5) or overweight/obese (BMI≥25)
age <18 or > 30 years
Inability to give valid consent
Presence of a chronic or acute illness.
Elevated physical activity level (assesses by the physical activity questionnaire)
Heavy smokers (≥1 pack per day).
Weight gain or loss of > 3% in the past 3 months
History of kidney stones

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

30 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Maya Bassil, PhD	Lebanese American University	Principal Investigator

Locations

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D010758	Phosphorus

Ancestor Terms

ID	Term
D004602	Elements
D007287	Inorganic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided