NCT02744001

Brief Summary

The purpose of this study is to determine how daily diet relates to eating choices.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Apr 2016

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

Study Start

First participant enrolled

April 1, 2016

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

April 15, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 19, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 16, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 16, 2018

Completed
Last Updated

February 2, 2022

Status Verified

January 1, 2022

Enrollment Period

1.8 years

First QC Date

April 15, 2016

Last Update Submit

January 18, 2022

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

  • Change in relative reinforcing value (RRV) of snacks as assessed by indicator

    RRV of snacks will be assessed by evaluating the number of responses (mouse button presses) a subject is willing to complete to gain access to a high added sugar snack or low added sugar alternative.

    Baseline and 1 week

Study Arms (1)

Low Added Sugar Diet

EXPERIMENTAL

Menu containing \<10% of total daily energy intake from added sugars.

Other: Low Added Sugar Diet

Interventions

Low Added Sugar DietOTHER

1-week intake of Low Added Sugar Diet 3 day rotating menu

Low Added Sugar Diet

Eligibility Criteria

Age18 Years - 39 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI within 18.5-24.9 kg/m2 or BMI within 30.0-50.0 kg/m2
  • Willing to consent to study conditions
  • Habitually consume at least 10% of daily energy intake from added sugars

You may not qualify if:

  • BMI 25.0-29.9 kg/m2
  • Currently taking drugs that change hunger
  • Have an eating disorder
  • Current tobacco user
  • Have diabetes or heart disease
  • Pregnant, lactating or planning pregnancy
  • Low liking of all available study test foods
  • Allergy/aversion to any of the foods provided during the diet intervention

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 Publications (1)

  • Flack KD, Ufholz K, Casperson S, Jahns L, Johnson L, Roemmich JN. Decreasing the Consumption of Foods with Sugar Increases Their Reinforcing Value: A Potential Barrier for Dietary Behavior Change. J Acad Nutr Diet. 2019 Jul;119(7):1099-1108. doi: 10.1016/j.jand.2018.12.016. Epub 2019 Apr 6.

    PMID: 30962120DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

  • James Roemmich, PhD

    USDA Grand Forks Human Nutrition Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 15, 2016

First Posted

April 19, 2016

Study Start

April 1, 2016

Primary Completion

January 16, 2018

Study Completion

January 16, 2018

Last Updated

February 2, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)