MedDataX Logo

Pilot Study on Mixed Nuts and Food Intake

NCT ID: NCT03247881

Last Updated: 2017-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-18

Study Completion Date

2017-11-06

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The condition of being overweight or obese has skyrocketed in recent decades, bringing with it many secondary health problems. Therefore, it is important to seek strategies to promote weight loss and to assist in weight maintenance after weight loss. Different diet compositions may have different effects on satiety and thus affect food choice. A pilot study will be conducted to determine if mixed nuts affect food selection and intake. Questionnaires will also be administered to determine if personality characteristics are also influencing food choice.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Volunteers

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Nut Free Diet

Participants will consume whatever they like, as much as they like, from a pre-determined buffet with 0 g/d of mixed nuts.

Group Type OTHER

Nut Free Diet

Intervention Type OTHER

Participants 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

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).

Group Type ACTIVE_COMPARATOR

Added Mixed Nuts Diet

Intervention Type OTHER

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).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Nut Free Diet

Participants will consume whatever they like, as much as they like, from a pre-determined buffet with 0 g/d of mixed nuts.

Intervention Type OTHER

Added Mixed Nuts Diet

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).

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Control Diet

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 21 to 60 Years Old
* 5 year cancer-free

Exclusion Criteria

* 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
* Self report of alcohol or substance abuse within the past 12 months and/or current acute treatment or participation in a rehabilitation program for those problems (long-term participation in Alcoholics Anonymous is not an exclusion)
Minimum Eligible Age

21 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

USDA Beltsville Human Nutrition Research Center

FED

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Janet Novotny

Research Physiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Janet Novotny

Role: PRINCIPAL_INVESTIGATOR

USDA-ARS, Beltsville Human Nutrition Research Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

USDA-ARS Beltsville Human Nutrition Research Center

Beltsville, Maryland, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HS57

Identifier Type: -

Identifier Source: org_study_id