Study Stopped
PI is retiring from Center. Research will not continue with a new PI.
Chronic Effects of Fats on Satiety & Energy Needs
1 other identifier
interventional
1
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2017
Shorter than P25 for not_applicable
1 active site
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
First Submitted
Initial submission to the registry
July 28, 2017
CompletedFirst Posted
Study publicly available on registry
August 1, 2017
CompletedStudy Start
First participant enrolled
October 3, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 24, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 24, 2018
CompletedAugust 3, 2018
August 1, 2018
8 months
July 28, 2017
August 1, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Acute effect of fat intake on energy expenditure as determined by metabolic rate
Incremental Area Under the Curve (iAUC) of metabolic rate from 0 to 4 hours
Study Arms (4)
Saturated Fat/SFA
OTHER30 grams saturated fat (SFA) in the form of heavy whipping cream will be provided to subject in a mixed meal shake
Monounsaturated Fat/MUFA
OTHER30 grams monounsaturated fat (MUFA) in the form of olive oil will be provided to subject in a mixed meal shake
Polyunsaturated Fat Linoleic/PUFA
OTHER30 grams high linoleic polyunsaturated fat (PUFA) in the form of high linoleic sunflower oil will be provided to subject in a mixed meal shake
Polyunsaturated Fat Omega-3/LCn3
OTHER30 grams high omega-3 polyunsaturated fat (LCn3) in the form of fish oil will be provided to subject in a mixed meal shake
Interventions
High polyunsaturated fatty acid (linoleic)/PUFA oil source
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
USDA Grand Forks Human Nutrition Research Center
Grand Forks, North Dakota, 58203, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Susan Raatz, PhD
USDA Grand Forks Human Nutrition Research Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 28, 2017
First Posted
August 1, 2017
Study Start
October 3, 2017
Primary Completion
May 24, 2018
Study Completion
May 24, 2018
Last Updated
August 3, 2018
Record last verified: 2018-08
Data Sharing
- IPD Sharing
- Will not share