Food AddictionNCT04105712
The Biobehavioral Impact of Diet Quality on Affect and Craving
A study testing Dietary Change (low in highly processed foods) in people with Food Addiction and Withdrawal, run by University of Michigan at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 25 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Food Addiction, Withdrawal
- What is being tested?
- Dietary Change (low in highly processed foods)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jun 2019to 21 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 25 to 40
- Access to internet, private computer and smart phone
- Overweight (self-report BMI above 25.0)
- Moderately or Highly motivated to eat a healthier diet
- Mild, moderate or severe levels of addictive like eating (2 or higher on the Yale Food Addiction Scale)
- Fluent in english
- Willing to follow dietary guidelines provided by study team and eat only provide food for 3 days. Willing to delay dietary change until instructed to do so
Who cannot join
- Use of nicotine in the past month, cannabis in the past month, or illicit drugs in the past 6 months
- Weight fluctuation of 20+ pounds in the last 3 months
- Attempted weight loss using a formal weight loss program (e.g. weight watchers) in the last month
- Prior weight loss surgery (e.g. bariatric surgery)
- Medications or medical conditions that may impact study results such as medications that impact appetite, heart rate, or reward functioning (e.g. taking synthroid or has diabetes)
- Current major psychiatric diagnoses (e.g., bipolar, schizophrenia, substance use disorder, eating disorder)
Show all 9Show fewer
- A diagnosis of a restrictive eating disorder in the past 5 years (anorexia nervosa, bulimia nervosa, purging disorder)
- Significant dietary restrictions (e.g. allergies, veganism)
- currently pregnant, breastfeeding, trying to get pregnant, or within 6 months of giving birth
Trial locations and contacts
1 site in 1 country.
About this study
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:
- 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).
- 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.
- 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.
- Conditions
- Food Addiction, Withdrawal
- Being tested
- Dietary Change (low in highly processed foods)
- Keywords
- withdrawal, highly processed food, food addiction
- Medical subject headings
- Food Addiction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary Change (low in highly processed foods)Behavioural
For post-dietary change, food is provided for 3 days (participants provide own food and do food journals the other 2 days to confirm adherence). University of Michigan's Nutrition Obesity Research Center (NORC)'s Metabolic Kitchen prepares the food. Low HP food diet is based on prior methods where participants are placed on an isocaloric diet composed of 5% or less of calories from added sugar and 10% or less of overall calories from total sugar. No foods that meet the criteria for a HP food (defined by Kant and colleagues) that corresponds to: sweeteners (sugar, candy, etc); carbonated and non-carbonated beverages (fruit drinks, sweetened / diet beverages, etc.); baked / dairy desserts (cookies, ice cream, etc.); salted snacks (potato chips, etc.) and fast foods (pizza, cheeseburgers, etc.) are included in diet portions. The overall macro nutrient composition of the diet will be approximately 20-25% of kcal from protein, 30-35% of kcal from fat, and 40-50% of kcal from carbohydrates.
| Study group | Role | What they receive |
|---|---|---|
| Pre and Post Dietary Change (within subjects) | Experimental | Participants do an initial call for baseline data. Then the active assessment period (pre / post dietary change) begins. Pre - dietary change procedure is 5 days of standard high HP diet while completing daily electronic assessments of withdrawal, ecological momentary assessments, and a phone appointment. Post - dietary change is 5 days of lower HP diet (food provided for 3 of 5 days) while completing daily electronic assessments of withdrawal, ecological momentary assessments, and a phone appointment. Daily assessments of affect, craving, and withdrawal are all virtual. On day 4-5 of post assessment, participants complete a food journal to report foods they ate to ensure compliance to low HP food diet. The pre / post-dietary change phone appointments include 1) psychosocial stress task, 2) cue reactivity task, 3) questionnaires 4) self-reported weight. Participants may also complete a follow up period of questionnaires every other day and self-report weight at the end of follow up. Receives: Behavioral: Dietary Change (low in highly processed foods) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase in affective withdrawal symptoms during post-dietary change assessment using the Highly Processed Food Withdrawal Scale (PRoWS).
The PRoWS is a validated self-report measure of indicators of withdrawal. Affective withdrawal symptoms are measured by asking participants to complete the Highly Processed Food Withdrawal Scale (PRoWS), which is a validated self-report measure of withdrawal. PRoWS questions ask about current feelings / emotions. Response options are "strongly disagree" "disagree" "feel neutral" "agree" and "strongly agree". Participants are asked to complete these measures every day of the pre and post dietary change. Change in self - report responses on the PRoWS at pre dietary change compared to post dietary change will be used for analyses.
Measured: Through study completion, an average of 1 month
Increase in negative affect during post-dietary change assessment using ecological momentary assessments (EMA).
Negative Affect is measured by asking participants to self-report affect (e.g., irritability, depression) on their smart phones throughout the day during pre and post dietary change. Participants are asked to give ratings of their current feelings / emotions and to provide contextual information (location, environment, etc.). Response options are a 5 points scale with extreme ends of scale marked as "strongly disagree" and "strongly agree". Changes in ratings from pre dietary change to post dietary change within subjects will be used for analyses
Measured: Through study completion, an average of 1 month
Increase in negative affect during post-dietary change assessment using Profile of Mood Scale (POMS).
Profile of Moods Scale - Abbreviated (POMS) is a well validated, self - report scale of affect. The POMS is used to measure daily global affect. The POMS asks about current feelings / emotions. Response options are "not at all" "a little" "moderate" "quite a bit" and "extremely." Participants are asked to complete these measures daily during pre and post dietary change. Change in self-report responses on the POMS at pre dietary change compared to post dietary change will be used for analyses.
Measured: Through study completion, an average of 1 month
Increase in stress reactivity during post-dietary change using the Positive and Negative Affect Scale (PANAS) as an indicator of negative affect during a stress - exposure task.
Participants will complete a stress task during pre and post dietary change. Food cue reactivity symptoms are measured by asking participants to complete the Positive and Negative Affect Scale (PANAS) which asked about current feeling / emotions. Response options are "very slightly / not at all" "a little" "moderately" "quite a bit" or "extremely." Participants are asked to complete these measures before and after completing a stress exposure task during the pre and post dietary change. The magnitude of change in self - report responses in negative affect in response to the stress task on the PANAS at pre dietary change compared to post dietary change will be used for analyses.
Measured: Through study completion, an average of 1 month
Increased propensity to experience food craving using ecological momentary assessment (EMA).
Food cravings are measured by asking participants to self-report food cravings and to provide contextual information (location, environment, etc.) on their smart phones throughout the day. Response options are a 5 points scale with extreme ends of scale marked as "strongly disagree" and "strongly agree". The magnitude of change in cravings ratings from pre dietary change to post dietary change within subjects will be used for analyses.
Measured: Through study completion, an average of 1 month
Increased propensity to experience food craving using the Food Craving Questionnaire (FCQ - S).
Food cravings are measured by asking participants to complete the Food Craving Questionnaire (FCQ-S) which is a validated measure of current food cravings. Response options are "Strongly Disagree" "Disagree" "Neutral" "Agree" or "Strongly Agree." Participants are asked to complete these measures daily during the pre and post dietary change. Change in self - report responses on the daily report FCQ-S at pre dietary change compared to post dietary change will be used for analyses.
Measured: Through study completion, an average of 1 month
Increased propensity to experience food craving in response to a cue reactivity task using the Food Craving Questionnaire (FCQ - S).
Participants will be shown commercial advertisement videos for highly processed foods during the pre and post dietary change. Food cravings are measured by asking participants to complete the Food Craving Questionnaire (FCQ-S) which is a validated measure of current food cravings. Response options are "Strongly Disagree" "Disagree" "Neutral" "Agree" or "Strongly Agree." The magnitude of change is self - report craving on this measure during pre-dietary change compared to post dietary change will be used for analyses.
Measured: Through study completion, an average of 1 month
Secondary outcomes (4)
Increased hunger in response to cue - reactivity task using subjective hunger measure.
Participants will be shown commercial advertisement videos for highly processed foods during the pre and post dietary change. Participant's subjective craving will be measured on a scale of 0 to 100. Change is self - report responses on this hunger self - report measures during pre-dietary change compared to post dietary change will be used for analyses.
Measured: Through study completion, an average of 1 month
Increased craving in response to cue reactivity task using subjective craving measure.
Participants will be shown commercial advertisement videos for highly processed foods during the pre and post dietary change. Participant's subjective hunger will be measured on a scale of 0 to 100. Change is self - report responses on these self - report measures during pre-dietary change compared to post dietary change will be used for analyses.
Measured: Through study completion, an average of 1 month
Increased hunger in response to stress exposure task using subjective measure of hunger.
Participants will complete a stress task during pre and post dietary change. Participants will listen to a personalized stress script foods during the pre and post dietary change. Participant's subjective hunger will be measured on a scale of 0 to 100. Change is self - report hunger on this self - report measures during pre-dietary change compared to post dietary change will be used for analyses.
Measured: Through study completion, an average of 1 month
Increased craving in response to stress exposure task using subjective measure of craving.
Participants will complete a stress task during pre and post dietary change. Participants will listen to a personalized stress script foods during the pre and post dietary change. Participant's subjective craving will be measured on a scale of 0 to 100. Change is self - report responses on these self - report measures during pre-dietary change compared to post dietary change will be used for analyses.
Measured: Through study completion, an average of 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2019
- Study start18 Jun 2019
- Primary completion21 Oct 2021
- Study completion21 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food AddictionStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Multi-method, within subjects, prospective, experimental design
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ashley Gearhardt, University of Michigan
- Investigators
- Ashley Gearhardt, Ph.D, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04105712
- Sponsor's protocol ID
- HUM00156725
- Status last verified
- Oct 2021
- First submitted
- 23 Sep 2019
- Last updated
- 1 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported will be de-identified and shared.
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Biobehavioral Impact of Diet Quality on Affect and Craving
- ClinicalTrials.gov ID
- NCT04105712
- Acronym / sponsor ID
- HUM00156725
- Conditions
- Food Addiction, Withdrawal
- Keywords
- withdrawal, highly processed food, food addiction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 18 Jun 2019 (actual)
- Primary completion
- 21 Oct 2021 (actual)
- Study completion
- 21 Oct 2021 (actual)
- First posted
- 26 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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).
- 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.
- 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Multi-method, within subjects, prospective, experimental design
| Arm | Type | Receives |
|---|---|---|
| Pre and Post Dietary Change (within subjects) | Experimental | Behavioral: Dietary Change (low in highly processed foods)Participants do an initial call for baseline data. Then the active assessment period (pre / post dietary change) begins. Pre - dietary change procedure is 5 days of standard high HP diet while completing daily electronic assessments of withdrawal, ecological momentary assessments, and a phone appointment. Post - dietary change is 5 days of lower HP diet (food provided for 3 of 5 days) while completing daily electronic assessments of withdrawal, ecological momentary assessments, and a phone appointment. Daily assessments of affect, craving, and withdrawal are all virtual. On day 4-5 of post assessment, participants complete a food journal to report foods they ate to ensure compliance to low HP food diet. The pre / post-dietary change phone appointments include 1) psychosocial stress task, 2) cue reactivity task, 3) questionnaires 4) self-reported weight. Participants may also complete a follow up period of questionnaires every other day and self-report weight at the end of follow up. |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age 25 to 40
- Access to internet, private computer and smart phone
- Overweight (self-report BMI above 25.0)
- Moderately or Highly motivated to eat a healthier diet
- Mild, moderate or severe levels of addictive like eating (2 or higher on the Yale Food Addiction Scale)
Key exclusion criteria (9 listed)
- Use of nicotine in the past month, cannabis in the past month, or illicit drugs in the past 6 months
- Weight fluctuation of 20+ pounds in the last 3 months
- Attempted weight loss using a formal weight loss program (e.g. weight watchers) in the last month
- Prior weight loss surgery (e.g. bariatric surgery)
- Medications or medical conditions that may impact study results such as medications that impact appetite, heart rate, or reward functioning (e.g. taking synthroid or has diabetes)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary Change (low in highly processed foods)For post-dietary change, food is provided for 3 days (participants provide own food and do food journals the other 2 days to confirm adherence). University of Michigan's Nutrition Obesity Research Center (NORC)'s Metabolic Kitchen prepares the food. Low HP food diet is based on prior methods where participants are placed on an isocaloric diet composed of 5% or less of calories from added sugar and 10% or less of overall calories from total sugar. No foods that meet the criteria for a HP food (defined by Kant and colleagues) that corresponds to: sweeteners (sugar, candy, etc); carbonated and non-carbonated beverages (fruit drinks, sweetened / diet beverages, etc.); baked / dairy desserts (cookies, ice cream, etc.); salted snacks (potato chips, etc.) and fast foods (pizza, cheeseburgers, etc.) are included in diet portions. The overall macro nutrient composition of the diet will be approximately 20-25% of kcal from protein, 30-35% of kcal from fat, and 40-50% of kcal from carbohydrates. | Behavioural | Pre and Post Dietary Change (within subjects) |
Primary outcome
Increase in affective withdrawal symptoms during post-dietary change assessment using the Highly Processed Food Withdrawal Scale (PRoWS).
Time frame: Through study completion, an average of 1 month
The PRoWS is a validated self-report measure of indicators of withdrawal. Affective withdrawal symptoms are measured by asking participants to complete the Highly Processed Food Withdrawal Scale (PRoWS), which is a validated self-report measure of withdrawal. PRoWS questions ask about current feelings / emotions. Response options are "strongly disagree" "disagree" "feel neutral" "agree" and "strongly agree". Participants are asked to complete these measures every day of the pre and post dietary change. Change in self - report responses on the PRoWS at pre dietary change compared to post dietary change will be used for analyses.
Increase in negative affect during post-dietary change assessment using ecological momentary assessments (EMA).
Time frame: Through study completion, an average of 1 month
Negative Affect is measured by asking participants to self-report affect (e.g., irritability, depression) on their smart phones throughout the day during pre and post dietary change. Participants are asked to give ratings of their current feelings / emotions and to provide contextual information (location, environment, etc.). Response options are a 5 points scale with extreme ends of scale marked as "strongly disagree" and "strongly agree". Changes in ratings from pre dietary change to post dietary change within subjects will be used for analyses
Increase in negative affect during post-dietary change assessment using Profile of Mood Scale (POMS).
Time frame: Through study completion, an average of 1 month
Profile of Moods Scale - Abbreviated (POMS) is a well validated, self - report scale of affect. The POMS is used to measure daily global affect. The POMS asks about current feelings / emotions. Response options are "not at all" "a little" "moderate" "quite a bit" and "extremely." Participants are asked to complete these measures daily during pre and post dietary change. Change in self-report responses on the POMS at pre dietary change compared to post dietary change will be used for analyses.
Increase in stress reactivity during post-dietary change using the Positive and Negative Affect Scale (PANAS) as an indicator of negative affect during a stress - exposure task.
Time frame: Through study completion, an average of 1 month
Participants will complete a stress task during pre and post dietary change. Food cue reactivity symptoms are measured by asking participants to complete the Positive and Negative Affect Scale (PANAS) which asked about current feeling / emotions. Response options are "very slightly / not at all" "a little" "moderately" "quite a bit" or "extremely." Participants are asked to complete these measures before and after completing a stress exposure task during the pre and post dietary change. The magnitude of change in self - report responses in negative affect in response to the stress task on the PANAS at pre dietary change compared to post dietary change will be used for analyses.
Increased propensity to experience food craving using ecological momentary assessment (EMA).
Time frame: Through study completion, an average of 1 month
Food cravings are measured by asking participants to self-report food cravings and to provide contextual information (location, environment, etc.) on their smart phones throughout the day. Response options are a 5 points scale with extreme ends of scale marked as "strongly disagree" and "strongly agree". The magnitude of change in cravings ratings from pre dietary change to post dietary change within subjects will be used for analyses.
Increased propensity to experience food craving using the Food Craving Questionnaire (FCQ - S).
Time frame: Through study completion, an average of 1 month
Food cravings are measured by asking participants to complete the Food Craving Questionnaire (FCQ-S) which is a validated measure of current food cravings. Response options are "Strongly Disagree" "Disagree" "Neutral" "Agree" or "Strongly Agree." Participants are asked to complete these measures daily during the pre and post dietary change. Change in self - report responses on the daily report FCQ-S at pre dietary change compared to post dietary change will be used for analyses.
Increased propensity to experience food craving in response to a cue reactivity task using the Food Craving Questionnaire (FCQ - S).
Time frame: Through study completion, an average of 1 month
Participants will be shown commercial advertisement videos for highly processed foods during the pre and post dietary change. Food cravings are measured by asking participants to complete the Food Craving Questionnaire (FCQ-S) which is a validated measure of current food cravings. Response options are "Strongly Disagree" "Disagree" "Neutral" "Agree" or "Strongly Agree." The magnitude of change is self - report craving on this measure during pre-dietary change compared to post dietary change will be used for analyses.
4 secondary outcomes
Increased hunger in response to cue - reactivity task using subjective hunger measure.
Time frame: Through study completion, an average of 1 month
Increased craving in response to cue reactivity task using subjective craving measure.
Time frame: Through study completion, an average of 1 month
Increased hunger in response to stress exposure task using subjective measure of hunger.
Time frame: Through study completion, an average of 1 month
Increased craving in response to stress exposure task using subjective measure of craving.
Time frame: Through study completion, an average of 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2021.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported will be de-identified and shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ashley Gearhardt, Ph.D principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary Change (low in highly processed foods) in people with Food Addiction and Withdrawal, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increase in affective withdrawal symptoms during post-dietary change assessment using the Highly Processed Food Withdrawal Scale (PRoWS). (time frame: Through study completion, an average of 1 month). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2021.