Pilot Study on Mixed Nuts and Food Intake
1 other identifier
interventional
12
1 country
1
Brief Summary
The objectives of this study are 1) to determine if consumption of mixed nuts influences food intake and choice, and 2) to determine how personality traits affect food choice, including mood, stress, tendency to seek approval, tendency toward food cravings, and approach to food intake control.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable healthy-volunteers
Started Sep 2017
Shorter than P25 for not_applicable healthy-volunteers
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
August 9, 2017
CompletedFirst Posted
Study publicly available on registry
August 14, 2017
CompletedStudy Start
First participant enrolled
September 18, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 6, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 6, 2017
CompletedNovember 14, 2017
November 1, 2017
2 months
August 9, 2017
November 9, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Body Mass will be measured
To track the change in body mass, subjects will be weighed on a scale.
Day 0, prior to beginning the diet, day 8, day 29, and day 60
Secondary Outcomes (2)
Questionnaires will be administered
Once during the study, no specific time.
Mood questionnaire will be administered
Day 0, Day 8, and Day 29.
Study Arms (2)
Nut Free Diet
OTHERParticipants will consume whatever they like, as much as they like, from a pre-determined buffet with 0 g/d of mixed nuts.
Added Mixed Nuts Diet
ACTIVE COMPARATORParticipants will consume whatever they like, as much as they like, from a pre-determined buffet which will include 2 servings (2 ounces) of mixed nuts per day (1 serving just prior to breakfast and 1 serving as an afternoon snack).
Interventions
Participants will consume whatever they like, as much as they like, from a pre-determined buffet with 0 g/d of mixed nuts.
Participants will consume whatever they like, as much as they like, from a pre-determined buffet which will include 2 servings (2 ounces) of mixed nuts per day (1 serving just prior to breakfast and 1 serving as an afternoon snack).
Eligibility Criteria
You may qualify if:
- to 60 Years Old
- year cancer-free
You may not qualify if:
- pregnant, lactating, or intending to become pregnant during the study
- known allergy to study foods, including nuts
- use of tobacco products
- history of bariatric surgery or nutrient malabsorption disease or diseases requiring special diet
- Crohn's disease or diverticulitis
- suspected or known strictures, fistulas, or physiological/mechanical GI obstruction
- Type 2 diabetes requiring the use of diabetes pills, insulin, or non-insulin shots
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
USDA-ARS Beltsville Human Nutrition Research Center
Beltsville, Maryland, 20705, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Janet Novotny
USDA-ARS, Beltsville Human Nutrition Research Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- FED
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Physiologist
Study Record Dates
First Submitted
August 9, 2017
First Posted
August 14, 2017
Study Start
September 18, 2017
Primary Completion
November 6, 2017
Study Completion
November 6, 2017
Last Updated
November 14, 2017
Record last verified: 2017-11
Data Sharing
- IPD Sharing
- Will not share