ObesityNCT02496936
Acute Effects of Fats on Satiety and Energy Needs
A study testing SFA, MUFA and PUFA-LA in people with 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 assess the acute effect of dietary fat on satiety and energy metabolism. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- SFA, MUFA and PUFA-LA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2015to 30 Oct 2019
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 9Show fewer
- willing to comply with study demands
- use of oral contraceptives
- low intake of long chain omega 3 fatty acids
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 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)
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
The purpose of this study is to assess the acute effect of dietary fat on satiety and energy metabolism.
Read the 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.
- Conditions
- Obesity
- Being tested
- SFA, MUFA, PUFA-LA, ALA, LCn3
- Keywords
- Energy Expenditure, Appetite, Satiety
- Medical subject headings
- 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
PUFA-LAOther
High polyunsaturated fatty acid (linoleic)/PUFA-LA oil source
ALAOther
High polyunsaturated fatty acid (alpha-linolenic)/ALA oil source
LCn3Other
High polyunsaturated fatty acid (omega-3)/LCn3 oil source
| Study group | Role | What they receive |
|---|---|---|
| Saturated Fat (SFA) | Experimental | 30 grams saturated fat in the form of heavy whipping cream will be provided to subject in a smoothie drink Receives: Other: SFA |
| Monounsaturated Fat (MUFA) | Experimental | 30 grams monounsaturated fat in the form of high oleic canola oil will be provided to subject in a smoothie drink Receives: Other: MUFA |
| Polyunsaturated Fat Linoleic (PUFA-LA) | Experimental | 30 grams polyunsaturated fat in the form of high linoleic sunflower oil will be provided to subject in a smoothie drink Receives: Other: PUFA-LA |
| Polyunsaturated Fat Alpha-Linolenic (ALA) | Experimental | 30 grams polyunsaturated fat in the form of flaxseed oil will be provided to subject in a smoothie drink Receives: Other: ALA |
| Polyunsaturated Fat Long Chain Omega-3 (LCn3) | Experimental | 30 grams polyunsaturated fat in the form of fish oil (Coromega Omega3 Squeeze) will be provided to subject in a smoothie drink 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 posted14 Jul 2015 (estimated)
- Study startDec 2015
- Primary completion30 Oct 2019
- Study completion30 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- USDA Grand Forks Human Nutrition Research Center
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Matthew Picklo, PhD, Principal investigator, USDA Grand Forks Human Nutrition Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02496936
- Sponsor's protocol ID
- GFHNRC508
- Status last verified
- Aug 2022
- First submitted
- 7 Jul 2015
- Last updated
- 4 Aug 2022
- 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 4 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Fats on Satiety and Energy Needs
- ClinicalTrials.gov ID
- NCT02496936
- Acronym / sponsor ID
- GFHNRC508
- Conditions
- Obesity
- Keywords
- Energy Expenditure, Appetite, Satiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- USDA Grand Forks Human Nutrition Research CenterUS federal agency
- Study start
- Dec 2015 (actual)
- Primary completion
- 30 Oct 2019 (actual)
- Study completion
- 30 Oct 2019 (actual)
- First posted
- 14 Jul 2015 (estimated)
- 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 assess the acute effect of dietary fat on satiety and energy metabolism.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Saturated Fat (SFA) | Experimental | Other: SFA30 grams saturated fat in the form of heavy whipping cream will be provided to subject in a smoothie drink |
| Monounsaturated Fat (MUFA) | Experimental | Other: MUFA30 grams monounsaturated fat in the form of high oleic canola oil will be provided to subject in a smoothie drink |
| Polyunsaturated Fat Linoleic (PUFA-LA) | Experimental | Other: PUFA-LA30 grams polyunsaturated fat in the form of high linoleic sunflower oil will be provided to subject in a smoothie drink |
| Polyunsaturated Fat Alpha-Linolenic (ALA) | Experimental | Other: ALA30 grams polyunsaturated fat in the form of flaxseed oil will be provided to subject in a smoothie drink |
| Polyunsaturated Fat Long Chain Omega-3 (LCn3) | Experimental | Other: LCn330 grams polyunsaturated fat in the form of fish oil (Coromega Omega3 Squeeze) will be provided to subject in a smoothie drink |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
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 disease
- 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) |
| PUFA-LAHigh polyunsaturated fatty acid (linoleic)/PUFA-LA oil source | Other | Polyunsaturated Fat Linoleic (PUFA-LA) |
| ALAHigh polyunsaturated fatty acid (alpha-linolenic)/ALA oil source | Other | Polyunsaturated Fat Alpha-Linolenic (ALA) |
| LCn3High polyunsaturated fatty acid (omega-3)/LCn3 oil source | Other | Polyunsaturated Fat Long Chain 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2022.
- Grand Forks Human Nutrition Research Center Current Nutrition StudiesLink provided by the sponsor.
- 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.
Matthew Picklo, 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-LA in people with 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 9 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: finished, as of the sponsor's last update on 4 Aug 2022. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 4 Aug 2022.