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Hunger, Satiety, and Metabolic Responses to High-fat Meals of Varying Fatty Acid Composition

Primary Purpose

Body Weight Changes

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MUFA-rich HF Meal
PUFA-rich HF Meal
SFA-rich HF Meal
Sponsored by
Texas Christian University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Body Weight Changes

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • BMI of >18.5-24.9kg/m2
  • Woman
  • 18-40yrs of age

Exclusion Criteria:

  • 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

Sites / Locations

  • Texas Christian UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

MUFA-rich HF Meal

PUFA-rich HF Meal

SFA-rich HF Meal

Arm Description

High-fat meal rich in monounsaturated fatty acids

High-fat meal rich in polyunsaturated fatty acids

High-fat meal rich in saturated fatty acids

Outcomes

Primary Outcome Measures

Peptide-YY

Secondary Outcome Measures

Visual Analog Scale

Full Information

First Posted
November 8, 2016
Last Updated
July 24, 2018
Sponsor
Texas Christian University
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1. Study Identification

Unique Protocol Identification Number
NCT02966444
Brief Title
Hunger, Satiety, and Metabolic Responses to High-fat Meals of Varying Fatty Acid Composition
Official Title
Hunger, Satiety, and Metabolic Responses to High-fat Meals of Varying Fatty Acid Composition
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 2016 (undefined)
Primary Completion Date
July 2018 (Anticipated)
Study Completion Date
July 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Texas Christian University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Body Weight Changes

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MUFA-rich HF Meal
Arm Type
Experimental
Arm Description
High-fat meal rich in monounsaturated fatty acids
Arm Title
PUFA-rich HF Meal
Arm Type
Experimental
Arm Description
High-fat meal rich in polyunsaturated fatty acids
Arm Title
SFA-rich HF Meal
Arm Type
Experimental
Arm Description
High-fat meal rich in saturated fatty acids
Intervention Type
Other
Intervention Name(s)
MUFA-rich HF Meal
Intervention Type
Other
Intervention Name(s)
PUFA-rich HF Meal
Intervention Type
Other
Intervention Name(s)
SFA-rich HF Meal
Primary Outcome Measure Information:
Title
Peptide-YY
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Visual Analog Scale
Time Frame
18 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: BMI of >18.5-24.9kg/m2 Woman 18-40yrs of age Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jada L Stevenson, PhD
Phone
817-257-6310
Email
jada.stevenson@tcu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jada L Stevenson, PhD
Organizational Affiliation
Texas Christian University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Texas Christian University
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76102
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jada L Stevenson, PhD
Phone
817-257-6310
Email
jada.stevenson@tcu.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Hunger, Satiety, and Metabolic Responses to High-fat Meals of Varying Fatty Acid Composition

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