NCT04105712

The Biobehavioral Impact of Diet Quality on Affect and Craving

Completed NA Last updated 1 November 2021

What this trial tests

NA trial testing Dietary Change (low in highly processed foods) in Food Addiction in 68 participants. Completed in 21 October 2021.

Timeline

18 June 2019

Primary endpoint
21 October 2021

21 October 2021

Quick facts

Lead sponsor	University of Michigan
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	basic science
Enrollment	68
Start date	18 June 2019
Primary completion	21 October 2021
Estimated completion	21 October 2021
Sites	1 location across United States

Drugs / interventions tested

• Dietary Change (low in highly processed foods)

Conditions studied

• Food Addiction — all drugs for Food Addiction →
• Withdrawal — all drugs for Withdrawal →

Sponsor

University of Michigan

Who can join

Adults 25 to 40, any sex, with Food Addiction or Withdrawal. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The current study experimentally investigates whether reducing highly processed (HP) foods (defined in this study as foods high in added sugars) leads to, psychological and / or behavioral indicators of withdrawal. The following hypotheses are tested:

1. To test the hypothesis that reducing highly processed food intake will result in higher daily reports of physical (e.g. headaches), cognitive (e.g. difficulty concentrating), and affective (e.g., irritability) withdrawal symptoms).
2. To test the hypothesis that reducing highly processed food intake will result in increased negative affect (e.g., irritability, depression) as indicated by and psychological (self - reported distress ratings; daily emotion / mood reports) measures.
3. To test the hypothesis that reducing highly processed food intake will result in increased food craving as indicated by psychological (self - report craving ratings; daily craving report) measures.

All activities are completed remotely. Participants complete 4 phone appointments with a trained member of the research team. Daily questionnaires and ecological momentary assessments are completed at home between phone appointments. The initial call signs electronic consent and gets baseline measurements (questionnaires). After the initial call, participants start an active assessment period (pre / post dietary change assessments). Pre-dietary change includes at home questionnaires and ecological momentary assessments while eating a typical diet. It also includes the second phone appointment. Post-dietary change includes at home questionnaires and ecological momentary assessments while consuming 3 days of food portions lower in highly processed foods. Participants will complete a food journal on the remaining 2 days of post - dietary change assessment to report what food they ate. Post - dietary change also includes the third phone appointment. The second and third phone appointments each include computer tasks and questionnaires. The final phone appointment is a debriefing interview. Participants planning to continue eating a healthier diet may also be invited to complete a follow-up period, which involves answering a short questionnaire at home every other day for two weeks. 7 individuals had in-person data collected prior to the pandemic requiring a shift to virtual data collection.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.