Brain Response to Dietary Interventions

NCT02637271 | Completed

• 1 other identifier: 109416/A16-0067-001
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

In order to better understand how commonly used dietary interventions for obesity influence brain activity and in turn people's ability to adhere to their healthy nutrition plan, the investigators need to study how people's brains react to food cues while undergoing such interventions. Our study will add to our understanding of neural (brain) regulation of hedonic and homeostatic mechanisms (i.e. pleasure and hunger) in influencing adherence to calorie-reduced eating plans.

Conditions

Obesity

Keywords

Calorie restriction; Meal replacement; fMRI; Food-cue reactivity; Obesity

Outcome Measures

Primary Outcomes (1)

• Change in fMRI Food-cue Reactivity

  Baseline (pre-intervention) and 3 weeks (post-intervention)

Secondary Outcomes (4)

• Change in sub-scales of the Food Craving Inventory

  Baseline (pre-intervention) and 3 weeks (post-intervention)

• Change in sub-scales of the Three-factor Eating Questionnaire

  Baseline (pre-intervention) and 3 weeks (post-intervention)

• Change in Power of Food Scale

  Baseline (pre-intervention) and 3 weeks (post-intervention)

• Change in Yale Food Addiction Scale

  Baseline (pre-intervention) and 3 weeks (post-intervention)

Study Arms (2)

Total Meal Replacement

EXPERIMENTAL

Participants will be provided instruction in the appropriate use of the meal replacement product. The participants will be directed to refrain from all items of food for a period of 21 days except for the meal replacement products and vitamin supplements provided by the investigators (1120 kcal/day). Optifast™ 800 total meal replacement shakes will be provided to the participants for the 21 day intervention period.

Other: Low calorie total meal replacement

Typical Diet

ACTIVE COMPARATOR

Participants will be directed to use portion control to maintain a calorie level no greater than 1120 kcal per day. The participants will be directed to continue to consume food and beverage items that are representative of their typical diet (with the exception of reduced portions). Participants will be provided resources to assist them in determining caloric content of foods eaten.

Other: Low calorie typical diet

Interventions

Low calorie total meal replacement OTHER

Participants will be provided instruction in the appropriate use of the meal replacement product. The participants will be directed to refrain from all items of food for a period of 21 days except for the meal replacement products and vitamin supplements provided by the investigators (1120 kcal/day). Optifast™ 800 total meal replacement shakes will be provided to the participants for the 21 day intervention period.

Total Meal Replacement

Low calorie typical diet OTHER

Participants will be directed to use portion control to maintain a calorie level no greater than 1120 kcal per day. The participants will be directed to continue to consume food and beverage items that are representative of their typical diet (with the exception of reduced portions). Participants will be provided resources to assist them in determining caloric content of foods eaten.

Typical Diet

Eligibility Criteria

• Age: 19 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age: 19-60 years
• BMI of 30-39.9 kg/m2 (upper limit due to scanner comfort/feasibility)

You may not qualify if:

• Participants unable to provide informed consent.
• Participants with motor, visual or hearing impairment.
• Females with irregular menstrual cycles.
• Patients currently diagnosed with diabetes mellitus, experiencing uncontrolled hypertension, history of ischemic heart disease, cerebrovascular accidents, neurological disease or current severe psychiatric illness (e.g. psychosis, schizophrenia, severe untreated depression, current suicidal ideation, and current or past suicide attempts), history of psychiatric hospitalization.
• Women who are pregnant or who are attempting to conceive.
• Participants with contraindications for fMRI scanning.
• aneurism clips
• any implanted medical devices (pacemaker, neurostimulator)
• known pregnancy
• shrapnel in body or any injury to eye involving metal
• any ferrous metal in body
• Participants with a history of eating disorders such as bulimia nervosa, anorexia nervosa and severe binge eating disorder.
• Participants with a history of substance abuse or alcohol abuse.
• Participants who are currently on or have been on within the past 4 weeks any anti-depressant, anti-epileptic, or anxiolytic medicines.
• Patients experiencing persistent loss of appetite, nausea or vomiting within the last 4 weeks.

Sponsors & Collaborators

• Texas Tech University: lead
• Société des Produits Nestlé (SPN): collaborator

Study Sites (1)

Texas Tech University - Department of Nutritional Sciences

Lubbock, Texas, 79409, United States

Location

Related Publications (6)

• Dye L, Warner P, Bancroft J. Food craving during the menstrual cycle and its relationship to stress, happiness of relationship and depression; a preliminary enquiry. J Affect Disord. 1995 Jun 8;34(3):157-64. doi: 10.1016/0165-0327(95)00013-d.

  PMID: 7560543 BACKGROUND

• White MA, Whisenhunt BL, Williamson DA, Greenway FL, Netemeyer RG. Development and validation of the food-craving inventory. Obes Res. 2002 Feb;10(2):107-14. doi: 10.1038/oby.2002.17.

  PMID: 11836456 BACKGROUND

• Lowe MR, Butryn ML, Didie ER, Annunziato RA, Thomas JG, Crerand CE, Ochner CN, Coletta MC, Bellace D, Wallaert M, Halford J. The Power of Food Scale. A new measure of the psychological influence of the food environment. Appetite. 2009 Aug;53(1):114-8. doi: 10.1016/j.appet.2009.05.016. Epub 2009 Jun 12.

  PMID: 19500623 BACKGROUND

• Stunkard AJ, Messick S. The three-factor eating questionnaire to measure dietary restraint, disinhibition and hunger. J Psychosom Res. 1985;29(1):71-83. doi: 10.1016/0022-3999(85)90010-8.

  PMID: 3981480 BACKGROUND

• Gearhardt AN, Corbin WR, Brownell KD. Preliminary validation of the Yale Food Addiction Scale. Appetite. 2009 Apr;52(2):430-6. doi: 10.1016/j.appet.2008.12.003. Epub 2008 Dec 11.

  PMID: 19121351 BACKGROUND

• Kahathuduwa CN, Davis T, O'Boyle M, Binks M. Do scores on the Food Craving Inventory and Three-Factor Eating Questionnaire correlate with expected brain regions of interest in people with obesity? Physiol Behav. 2018 May 1;188:1-10. doi: 10.1016/j.physbeh.2018.01.018. Epub 2018 Feb 3.

  PMID: 29421336 DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Martin Binks, PhD

  Texas Tech University - Department of Nutritional Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2015
• First Posted: December 22, 2015
• Study Start: January 1, 2016
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: September 2, 2016

Record last verified: 2015-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)