NCT02496936

Brief Summary

The purpose of this study is to assess the acute effect of dietary fat on satiety and energy metabolism.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Dec 2015

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 7, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 14, 2015

Completed
5 months until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2019

Completed
Last Updated

August 4, 2022

Status Verified

August 1, 2022

Enrollment Period

3.9 years

First QC Date

July 7, 2015

Last Update Submit

August 1, 2022

Conditions

Obesity

Keywords

Energy ExpenditureAppetiteSatiety

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 (5)

Saturated Fat (SFA)

EXPERIMENTAL

30 grams saturated fat in the form of heavy whipping cream will be provided to subject in a smoothie drink

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

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

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

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

Other: LCn3

Interventions

SFAOTHER

High saturated fatty acid/SFA oil source

Saturated Fat (SFA)
MUFAOTHER

High monounsaturated fatty acid/MUFA oil source

Monounsaturated Fat (MUFA)
PUFA-LAOTHER

High polyunsaturated fatty acid (linoleic)/PUFA-LA oil source

Polyunsaturated Fat Linoleic (PUFA-LA)
ALAOTHER

High polyunsaturated fatty acid (alpha-linolenic)/ALA oil source

Polyunsaturated Fat Alpha-Linolenic (ALA)
LCn3OTHER

High polyunsaturated fatty acid (omega-3)/LCn3 oil source

Polyunsaturated Fat Long Chain Omega-3 (LCn3)

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

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 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)

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

Location

Related Links

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Matthew Picklo, PhD

    USDA Grand Forks Human Nutrition Research Center

    PRINCIPAL INVESTIGATOR

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 7, 2015

First Posted

July 14, 2015

Study Start

December 1, 2015

Primary Completion

October 30, 2019

Study Completion

October 30, 2019

Last Updated

August 4, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)