- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02496936
Acute Effects of Fats on Satiety and Energy Needs
August 1, 2022 updated by: USDA Grand Forks Human Nutrition Research Center
The purpose of this study is to assess the acute effect of dietary fat on satiety and energy metabolism.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The influences of specific dietary fat sources on satiety, appetite and energy utilization remains unclear; evidence is lacking on whether responses vary according to acute intake.
The researchers will use a controlled setting to determine whether the source of dietary fat is related to perceived satiety, satiety hormone responses, and energy expenditure by conducting experiments to evaluate short term (acute) effects.
Study Type
Interventional
Enrollment (Actual)
23
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
North Dakota
-
Grand Forks, North Dakota, United States, 58203
- USDA Grand Forks Human Nutrition Research Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- body mass index between 18.0-34.9 kg/m2
- free of major diagnosed, untreated medical conditions
- controlled hypertension
- non-smoking or use of other tobacco products, including e-cigarettes
- not taking steroid-based medications
- not planning to or currently attempting to gain or lose weight
- willing to comply with study demands
- use of oral contraceptives
- low intake of long chain omega 3 fatty acids
Exclusion Criteria:
- diagnosed eating disorders
- diabetes (blood sugar ≥ 126 mg/dl)
- hypertension (systolic ≥ 160 mmHg or diastolic > 100 mmHg)
- diagnosed cardiovascular, pulmonary, skeletal and metabolic disease
- currently pregnant or planning to become pregnant, or lactating
- taking medications known to affect appetite, blood lipids, body composition, body weight, or food intake (appetite control drugs, steroids, antidepressants)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Saturated Fat (SFA)
30 grams saturated fat in the form of heavy whipping cream will be provided to subject in a smoothie drink
|
High saturated fatty acid/SFA oil source
|
Experimental: Monounsaturated Fat (MUFA)
30 grams monounsaturated fat in the form of high oleic canola oil will be provided to subject in a smoothie drink
|
High monounsaturated fatty acid/MUFA oil source
|
Experimental: Polyunsaturated Fat Linoleic (PUFA-LA)
30 grams polyunsaturated fat in the form of high linoleic sunflower oil will be provided to subject in a smoothie drink
|
High polyunsaturated fatty acid (linoleic)/PUFA-LA oil source
|
Experimental: Polyunsaturated Fat Alpha-Linolenic (ALA)
30 grams polyunsaturated fat in the form of flaxseed oil will be provided to subject in a smoothie drink
|
High polyunsaturated fatty acid (alpha-linolenic)/ALA oil source
|
Experimental: Polyunsaturated Fat Long Chain Omega-3 (LCn3)
30 grams polyunsaturated fat in the form of fish oil (Coromega Omega3 Squeeze) will be provided to subject in a smoothie drink
|
High polyunsaturated fatty acid (omega-3)/LCn3 oil source
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Acute effect of fat intake on energy expenditure as determined by metabolic rate
Time Frame: Incremental Area Under the Curve (iAUC) of metabolic rate from 0 to 4 hours
|
Incremental Area Under the Curve (iAUC) of metabolic rate from 0 to 4 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Matthew Picklo, PhD, USDA Grand Forks Human Nutrition Research Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2015
Primary Completion (Actual)
October 30, 2019
Study Completion (Actual)
October 30, 2019
Study Registration Dates
First Submitted
July 7, 2015
First Submitted That Met QC Criteria
July 10, 2015
First Posted (Estimate)
July 14, 2015
Study Record Updates
Last Update Posted (Actual)
August 4, 2022
Last Update Submitted That Met QC Criteria
August 1, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- GFHNRC508
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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