NCT02594787

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

Trial Health

100
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2011

Typical duration for not_applicable

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, 2011

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

November 1, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 3, 2015

Completed
Last Updated

November 3, 2015

Status Verified

November 1, 2015

Enrollment Period

2.8 years

First QC Date

November 1, 2015

Last Update Submit

November 2, 2015

Conditions

Imbalance of Constituents of Food IntakeHealthy

Outcome Measures

Primary Outcomes (1)

  • Diet Induced Thermogenesis

    Diet Induced Thermogenesis will be measured using indirect calorimetry (VO2 consumption)

    180 minutes (measured every 30 min)

Study Arms (2)

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

PhosphorusDIETARY_SUPPLEMENT
Phosphorus
PlaceboDIETARY_SUPPLEMENT
Placebo

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Phosphorus

Intervention Hierarchy (Ancestors)

ElementsInorganic Chemicals

Study Officials

  • Maya Bassil, PhD

    Lebanese American University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 1, 2015

First Posted

November 3, 2015

Study Start

March 1, 2011

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

November 3, 2015

Record last verified: 2015-11