Diet, Imaging and Energy Balance Trial (DIET)

NCT00787280 | Completed

• 1 other identifier: Pro00002610
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate whether changes in macronutrient consumption (i.e., switching to a diet low in carbohydrates) can change brain responses to cues depicting foods representing that macronutrient. In addition to answering specific questions regarding the effects of an LCKD, the study will provide general information about relations between brain responses to food cues and a broad arrive of factors including typical diet, food preferences, weight control history and genes.

Conditions

Obesity

Keywords

obese; overweight; fMRI; Diet

Outcome Measures

Primary Outcomes (1)

• Compared to individuals in the LFD group, individuals placed on an LCKD will exhibit decreased brain responses to high-carbohydrate food cues.

  1 month

Secondary Outcomes (1)

• In addition to these questions, we will also examine relations between food consumption acquired from the diaries, genetic factors and brain function.

  1 month

Study Arms (2)

Low Carbohydrate Ketogenic Diet (LCKD)

EXPERIMENTAL

participants will follow a low carbohydrate ketogenic diet for six weeks

Behavioral: Low Carbohydrate Ketogenic Diet (LCKD)

Low Fat Diet (LFD)

EXPERIMENTAL

particpants will follow a low fat diet for six weeks

Behavioral: Low Fat Diet (LFD)

Interventions

Low Carbohydrate Ketogenic Diet (LCKD) BEHAVIORAL

participants will follow a low carbohydrate ketogenic diet for six weeks

Low Carbohydrate Ketogenic Diet (LCKD)

Low Fat Diet (LFD) BEHAVIORAL

particpants will follow a low fat diet for six weeks

Low Fat Diet (LFD)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participants must be 18-50 years old, right handed and have a BMI \> 27 kg/m². They must be willing to follow either of the two diets.

You may not qualify if:

• weigh over 300lbs.
• have uncontrolled hypertension (systolic \>160mm Hg, diastolic \>100mm Hg)
• have hypotension (systolic \<90 mm Hg, diastolic \<60 mm Hg)
• have coronary heart disease, or cardiac rhythm disorder
• cerebrovascular disease or peripheral vascular disease that requires intensive hyperlipidemic therapy
• other significant co-morbid illnesses such as liver disease (AST or ALT \> 100), kidney disease (serum creatinine \> 1.5), cancer, severe emphysema, severe hypertriglyceridemia (TG\>500)
• have diabetes (insulin or diet controlled)
• have a current psychiatric disease
• have current alcohol abuse (greater than 12 drinks per week)
• have current drug abuse (or treatment within the last year)
• use of psychiatric medications (including antidepressants, anti-anxiety agents, anti-psychotics, "muscle relaxants" or any other drug that influences mood, cognition, or neurotransmitter systems, i.e. dopamine, norepinephrine, acetylcholine, serotonin, GABA, and glutamate)
• have had or have an eating disorder including anorexia nervosa, bulimia nervosa, eating disorder not otherwise specified, binge eating disorder, or any other form of disordered eating
• have had any bariatric/weight loss surgery
• be taking any diet pills (prescription or over the counter)
• have been on any diet in the last 3 months

Sponsors & Collaborators

• Duke University: lead
• Robert C. Atkins Foundation: collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Obesity; Overweight

Interventions

Diet, Fat-Restricted

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Francis J McClernon, Ph.D

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 6, 2008
• First Posted: November 7, 2008
• Study Start: August 1, 2008
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: February 20, 2013

Record last verified: 2013-02

Locations

US (1)