OverweightNCT03236181
Chronic Effects of Fats on Satiety & Energy Needs
A study testing SFA, MUFA and PUFA in people with Overweight and Obesity, run by USDA Grand Forks Human Nutrition Research Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- SFA, MUFA and PUFA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Oct 2017to 24 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
USDA Grand Forks Human Nutrition Research Center
Grand Forks, North Dakota, 58203
About this study
Official title: 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.
Read the 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.
- Conditions
- Overweight, Obesity
- Being tested
- SFA, MUFA, PUFA, LCn3
- Keywords
- Energy Expenditure, Appetite, Satiety
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SFAOther
High saturated fatty acid/SFA oil source
MUFAOther
High monounsaturated fatty acid/MUFA oil source
PUFAOther
High polyunsaturated fatty acid (linoleic)/PUFA oil source
LCn3Other
High polyunsaturated fatty acid (omega-3)/LCn3 oil source
| Study group | Role | What they receive |
|---|---|---|
| Saturated Fat/SFA | Other | 30 grams saturated fat (SFA) in the form of heavy whipping cream will be provided to subject in a mixed meal shake Receives: Other: SFA |
| Monounsaturated Fat/MUFA | Other | 30 grams monounsaturated fat (MUFA) in the form of olive oil will be provided to subject in a mixed meal shake Receives: Other: MUFA |
| Polyunsaturated Fat Linoleic/PUFA | Other | 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 Receives: Other: PUFA |
| Polyunsaturated Fat Omega-3/LCn3 | Other | 30 grams high omega-3 polyunsaturated fat (LCn3) in the form of fish oil will be provided to subject in a mixed meal shake Receives: Other: LCn3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute effect of fat intake on energy expenditure as determined by metabolic rate
Measured: Incremental Area Under the Curve (iAUC) of metabolic rate from 0 to 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2017
- Study start3 Oct 2017
- Primary completion24 May 2018
- Study completion24 May 2018
Why it stopped: PI is retiring from Center. Research will not continue with a new PI.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- USDA Grand Forks Human Nutrition Research Center
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Susan Raatz, PhD, Principal investigator, USDA Grand Forks Human Nutrition Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03236181
- Sponsor's protocol ID
- GFHNRC509
- Status last verified
- Aug 2018
- First submitted
- 28 Jul 2017
- Last updated
- 3 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Effects of Fats on Satiety and Energy Expenditure
- ClinicalTrials.gov ID
- NCT03236181
- Acronym / sponsor ID
- GFHNRC509
- Conditions
- Overweight, Obesity
- Keywords
- Energy Expenditure, Appetite, Satiety
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI is retiring from Center. Research will not continue with a new PI.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- USDA Grand Forks Human Nutrition Research CenterUS federal agency
- Study start
- 3 Oct 2017 (actual)
- Primary completion
- 24 May 2018 (actual)
- Study completion
- 24 May 2018 (actual)
- First posted
- 1 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Saturated Fat/SFA | Other | Other: SFA30 grams saturated fat (SFA) in the form of heavy whipping cream will be provided to subject in a mixed meal shake |
| Monounsaturated Fat/MUFA | Other | Other: MUFA30 grams monounsaturated fat (MUFA) in the form of olive oil will be provided to subject in a mixed meal shake |
| Polyunsaturated Fat Linoleic/PUFA | Other | Other: PUFA30 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 | Other | Other: LCn330 grams high omega-3 polyunsaturated fat (LCn3) in the form of fish oil will be provided to subject in a mixed meal shake |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SFAHigh saturated fatty acid/SFA oil source | Other | Saturated Fat/SFA |
| MUFAHigh monounsaturated fatty acid/MUFA oil source | Other | Monounsaturated Fat/MUFA |
| PUFAHigh polyunsaturated fatty acid (linoleic)/PUFA oil source | Other | Polyunsaturated Fat Linoleic/PUFA |
| LCn3High polyunsaturated fatty acid (omega-3)/LCn3 oil source | Other | Polyunsaturated Fat Omega-3/LCn3 |
Primary outcome
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
Results and safety
The study was stopped early (reason given: PI is retiring from Center. Research will not continue with a new PI.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan Raatz, PhD principal investigator
USDA Grand Forks Human Nutrition Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SFA, MUFA and PUFA in people with Overweight and Obesity, run by USDA Grand Forks Human Nutrition Research Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: PI is retiring from Center. Research will not continue with a new PI.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2018.