NCT02629900

Brief Summary

Participants will complete a one-month intervention where they are will restrict their daily food intake to an 8-hour time period, i.e., between 1200 to 2000 hours. During the remaining 16-hour intermittent fasting period (2000 to 1200 hours) participants will be allowed to drink zero calorie beverages (diet soda pop, black coffee, tea, water, etc) in order to maintain normal hydration. There will be no attempt to restrict food intake. Rather simply to restrict the time period each day when food is consumed. Participants' body mass, fat mass, and non-fat mass will be monitored non-invasively using a weigh scale and densitometry via air displacement (Bod Pod) at 0, 2 and 4 weeks following the dietary intervention. Also, participants will be interviewed following the final body composition measure to assess whether or not they continued to follow the intermittent fasting approach.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 10, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 14, 2015

Completed
18 days until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

January 20, 2016

Status Verified

January 1, 2016

Enrollment Period

3 months

First QC Date

December 10, 2015

Last Update Submit

January 18, 2016

Conditions

Weight Loss

Keywords

Weight LossIntermittent fasting

Outcome Measures

Primary Outcomes (1)

  • Fat mass change over 4 weeks period of intervention

    Body fat mass change (%) will be measured using BodPod over the course of 4 weeks at 0, 2 and 4 weeks

    4 weeks

Secondary Outcomes (6)

  • Non-fat mass change over 4 weeks period of intervention

    4 weeks

  • Urine acidity change over 4 weeks of intervention

    4 weeks

  • Blood sugar change over 4 weeks of intervention

    4 weeks

  • Diet satisfaction change over 4 weeks of intervention

    4 weeks

  • Feeling of hunger change over 4 weeks of intervention

    4 weeks

  • +1 more secondary outcomes

Study Arms (1)

Intermittent fasting group

EXPERIMENTAL

Participants will restrict their daily food intake (time restricted feeding) to an 8-hour time period between 1200 to 2000 hours. During the remaining 16-hour intermittent fasting period (2000 to 1200 hours) participants will be allowed to drink zero calorie beverages (diet soda pop, black coffee, tea, water, etc) in order to maintain normal hydration. There will be no attempt to restrict food intake. Rather simply to restrict the time period each day when food is consumed.

Behavioral: Time restricted feeding

Interventions

Time restricted feedingBEHAVIORAL

Participants will consume their daily calories only between 12:00 and 20:00 for 4 weeks

Intermittent fasting group

Eligibility Criteria

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

You may qualify if:

  • Asymptomatic participants between the ages of 18-30 years with body mass index ˃25 will be studied

You may not qualify if:

  • Diabetic
  • Pregnant
  • Individuals with a history of fainting
  • Low blood sugar
  • Heart disease, migranes, or heart burn
  • Participants less then 18 of age
  • Anyone who for health or performance reasons should not skip breakfast will be excluded. These will be assessed by self report

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Exercise Nutrition Research Laboratory, Western University

London, Ontario, N6A 3K7, Canada

RECRUITING

MeSH Terms

Conditions

Weight LossIntermittent Fasting

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsFastingFeeding BehaviorBehavior

Study Officials

  • Peter Lemon, PhD

    Western University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter Lemon, PhD

CONTACT

1 519 661 2111plemon@uwo.ca

Siobhan Smith, Bsc

CONTACT

ssmit422@uwo.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

December 10, 2015

First Posted

December 14, 2015

Study Start

January 1, 2016

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

January 20, 2016

Record last verified: 2016-01

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)