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Chronic Effects of Fats on Satiety & Energy Needs

Primary Purpose

Overweight, Obesity

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SFA
MUFA
PUFA
LCn3
Sponsored by
USDA Grand Forks Human Nutrition Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Overweight focused on measuring Energy Expenditure, Appetite, Satiety

Eligibility Criteria

20 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • USDA Grand Forks Human Nutrition Research Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Other

Other

Other

Arm Label

Saturated Fat/SFA

Monounsaturated Fat/MUFA

Polyunsaturated Fat Linoleic/PUFA

Polyunsaturated Fat Omega-3/LCn3

Arm Description

30 grams saturated fat (SFA) in the form of heavy whipping cream will be provided to subject in a mixed meal shake

30 grams monounsaturated fat (MUFA) in the form of olive oil will be provided to subject in a mixed meal shake

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

30 grams high omega-3 polyunsaturated fat (LCn3) in the form of fish oil will be provided to subject in a mixed meal shake

Outcomes

Primary Outcome Measures

Acute effect of fat intake on energy expenditure as determined by metabolic rate

Secondary Outcome Measures

Full Information

First Posted
July 28, 2017
Last Updated
August 1, 2018
Sponsor
USDA Grand Forks Human Nutrition Research Center
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1. Study Identification

Unique Protocol Identification Number
NCT03236181
Brief Title
Chronic Effects of Fats on Satiety & Energy Needs
Official Title
Chronic Effects of Fats on Satiety and Energy Expenditure
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Terminated
Why Stopped
PI is retiring from Center. Research will not continue with a new PI.
Study Start Date
October 3, 2017 (Actual)
Primary Completion Date
May 24, 2018 (Actual)
Study Completion Date
May 24, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
USDA Grand Forks Human Nutrition Research Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity
Keywords
Energy Expenditure, Appetite, Satiety

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Saturated Fat/SFA
Arm Type
Other
Arm Description
30 grams saturated fat (SFA) in the form of heavy whipping cream will be provided to subject in a mixed meal shake
Arm Title
Monounsaturated Fat/MUFA
Arm Type
Other
Arm Description
30 grams monounsaturated fat (MUFA) in the form of olive oil will be provided to subject in a mixed meal shake
Arm Title
Polyunsaturated Fat Linoleic/PUFA
Arm Type
Other
Arm Description
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
Arm Title
Polyunsaturated Fat Omega-3/LCn3
Arm Type
Other
Arm Description
30 grams high omega-3 polyunsaturated fat (LCn3) in the form of fish oil will be provided to subject in a mixed meal shake
Intervention Type
Other
Intervention Name(s)
SFA
Intervention Description
High saturated fatty acid/SFA oil source
Intervention Type
Other
Intervention Name(s)
MUFA
Intervention Description
High monounsaturated fatty acid/MUFA oil source
Intervention Type
Other
Intervention Name(s)
PUFA
Intervention Description
High polyunsaturated fatty acid (linoleic)/PUFA oil source
Intervention Type
Other
Intervention Name(s)
LCn3
Intervention Description
High polyunsaturated fatty acid (omega-3)/LCn3 oil source
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan Raatz, PhD
Organizational Affiliation
USDA Grand Forks Human Nutrition Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
USDA Grand Forks Human Nutrition Research Center
City
Grand Forks
State/Province
North Dakota
ZIP/Postal Code
58203
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Chronic Effects of Fats on Satiety & Energy Needs

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