- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03236181
Chronic Effects of Fats on Satiety & Energy Needs
August 1, 2018 updated by: USDA Grand Forks Human Nutrition Research Center
Chronic Effects of Fats on Satiety and Energy Expenditure
The purpose of this study is to evaluate the effect of dietary fat on satiety (the experience of fullness between one meal and the next) and energy metabolism over an extended period of time (chronic effects).
How dietary fat sources affect satiety, appetite and energy use is unclear.
The investigators will use a controlled setting for the studies.
They want to know if the source of dietary fat alters satiety, satiety hormones, and energy expenditure responses after consuming different diets.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
This work will address the interaction of obesity and dietary fatty acids in regulating satiety and energy metabolism.
The primary objective is to determine the effects of chronic intake of dietary fatty acids of varied saturation and chain length on satiety, thermogenesis and energy utilization in healthy individuals.
The investigators hypothesize that unsaturated fatty acids will 1) increase satiety and 2) increase energy metabolism and that 3) the fatty acid binding protein polymorphisms are associated with reduced energy expenditure in response to dietary fat intake.
Study Type
Interventional
Enrollment (Actual)
1
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
20 years to 55 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- body mass index between 25.0-34.9 kg/m2
- free of major diagnosed, untreated medical conditions
- 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
- low intake of long chain omega-3 fatty acids (<0.10 g/d) or willing to reduce intake for 6 weeks prior to starting the study
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 diseases
- 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
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: Saturated Fat/SFA
30 grams saturated fat (SFA) in the form of heavy whipping cream will be provided to subject in a mixed meal shake
|
High saturated fatty acid/SFA oil source
|
OTHER: Monounsaturated Fat/MUFA
30 grams monounsaturated fat (MUFA) in the form of olive oil will be provided to subject in a mixed meal shake
|
High monounsaturated fatty acid/MUFA oil source
|
OTHER: Polyunsaturated Fat Linoleic/PUFA
30 grams high linoleic polyunsaturated fat (PUFA) in the form of high linoleic sunflower oil will be provided to subject in a mixed meal shake
|
High polyunsaturated fatty acid (linoleic)/PUFA oil source
|
OTHER: Polyunsaturated Fat Omega-3/LCn3
30 grams high omega-3 polyunsaturated fat (LCn3) in the form of fish oil will be provided to subject in a mixed meal shake
|
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: Susan Raatz, PhD, USDA Grand Forks Human Nutrition Research Center
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)
October 3, 2017
Primary Completion (ACTUAL)
May 24, 2018
Study Completion (ACTUAL)
May 24, 2018
Study Registration Dates
First Submitted
July 28, 2017
First Submitted That Met QC Criteria
July 28, 2017
First Posted (ACTUAL)
August 1, 2017
Study Record Updates
Last Update Posted (ACTUAL)
August 3, 2018
Last Update Submitted That Met QC Criteria
August 1, 2018
Last Verified
August 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GFHNRC509
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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