NCT03079635

Brief Summary

The purpose of this research is to determine if body composition influence the effect of breakfast composition on postprandial (post-meal) hunger, metabolic and energy expenditure response in normal weight, overweight, and obese young women.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
29

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Feb 2017

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

February 15, 2017

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

March 9, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 14, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2017

Completed
Last Updated

August 21, 2017

Status Verified

August 1, 2017

Enrollment Period

4 months

First QC Date

March 9, 2017

Last Update Submit

August 16, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Energy metabolism/expenditure

    Energy expenditure and thermic effect of feeding will be measured using a TrueMax 2400 metabolic cart

    Four hours

Secondary Outcomes (1)

  • Appetite

    Four hours

Study Arms (2)

Normal Weight

ACTIVE COMPARATOR

This group will be administered two breakfast beverages with a one- to two-week washout period between beverages. The beverages will be a control or an isocaloric, macronutrient matched breakfast beverage with omega-3 fatty acids.

Dietary Supplement: ControlDietary Supplement: Omega 3 fatty acids

Overweight and Obese

ACTIVE COMPARATOR

This group will be administered two breakfast beverages with a one- to two-week washout period between beverages. The beverages will be a control or an isocaloric, macronutrient matched breakfast beverage with omega-3 fatty acids.

Dietary Supplement: ControlDietary Supplement: Omega 3 fatty acids

Interventions

ControlDIETARY_SUPPLEMENT

Beverage provided and a four hour postprandial assessment of energy metabolism using a metabolic cart and appetite using a visual analog scale follows.

Normal WeightOverweight and Obese
Omega 3 fatty acidsDIETARY_SUPPLEMENT

Beverage provided and a four hour postprandial assessment of energy metabolism using a metabolic cart and appetite using a visual analog scale follows.

Normal WeightOverweight and Obese

Eligibility Criteria

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

You may qualify if:

  • BMI over 18.5
  • No medication

You may not qualify if:

  • Food allergies
  • Habitual breakfast skipping (\> 5 times per week)
  • Picky eater
  • Dietary restrictions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Arkansas

Fayetteville, Arkansas, 72704, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

Fatty Acids, Omega-3

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsFish OilsOils

Study Design

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

Study Record Dates

First Submitted

March 9, 2017

First Posted

March 14, 2017

Study Start

February 15, 2017

Primary Completion

June 1, 2017

Study Completion

June 30, 2017

Last Updated

August 21, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

Locations