NCT02966444

Brief Summary

This study evaluates the effects of dietary fatty acid composition from high fat meals on markers of hunger, satiety and metabolism.

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 Oct 2016

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 8, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 17, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

July 26, 2018

Status Verified

July 1, 2018

Enrollment Period

1.7 years

First QC Date

November 8, 2016

Last Update Submit

July 24, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Peptide-YY

    18 months

Secondary Outcomes (1)

  • Visual Analog Scale

    18 months

Study Arms (3)

MUFA-rich HF Meal

EXPERIMENTAL

High-fat meal rich in monounsaturated fatty acids

Other: MUFA-rich HF Meal

PUFA-rich HF Meal

EXPERIMENTAL

High-fat meal rich in polyunsaturated fatty acids

Other: PUFA-rich HF Meal

SFA-rich HF Meal

EXPERIMENTAL

High-fat meal rich in saturated fatty acids

Other: SFA-rich HF Meal

Interventions

MUFA-rich HF Meal
PUFA-rich HF Meal
SFA-rich HF Meal

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI of \>18.5-24.9kg/m2
  • Woman
  • yrs of age

You may not qualify if:

  • Evidence of weight loss or gain exceeding 5% of their body weight within the past 3 months.
  • Plans to lose weight or begin a weight loss program between initiation of study and final testing.
  • Plans to begin an exercise program or change current exercise routines between initiation of study and final testing.
  • Is on a medically prescribed diet
  • Does not consume breakfast regularly
  • Rate less than 80% of foods offered in the buffet at 50mm or more on the 100mm VAS as palatable
  • Medications that could influence appetite or sensory function
  • Reports of metabolic or endocrine disease, gastrointestinal disorders, or history of medical or surgical events that could affect fat digestion and hormone signaling.
  • Any chronic disease including type II diabetes, hypothyroidism, hyperthyroidism, cardiovascular disease, and cancer
  • Any supplements that a subject begins taking between initiation of study and final testing.
  • Anyone who is currently pregnant, lactating, or planning on becoming pregnant before the conclusion of this study.
  • Anyone who has allergies to any of the components of the liquid meals
  • Anyone who has donated blood in the last 20 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Texas Christian University

Fort Worth, Texas, 76102, United States

RECRUITING

MeSH Terms

Conditions

Body Weight Changes

Condition Hierarchy (Ancestors)

Body WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jada L Stevenson, PhD

    Texas Christian University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jada L Stevenson, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 8, 2016

First Posted

November 17, 2016

Study Start

October 1, 2016

Primary Completion

July 1, 2018

Study Completion

July 1, 2018

Last Updated

July 26, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations