Effects of Macronutrient Diet on Brain Activity

NCT02300857 | Completed

• 1 other identifier: 2014P001880
• Study Type: interventional
• Target: 72
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will evaluate the effect of macronutrient diets on brain activity in homeostatic and mesolimbic reward regions.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Blood flow to the nucleus accumbens and connected striatal regions

  Regional cerebral blood flow (rCBF) measured using arterial spin labeling (ASL) at rest, in neuroanatomically-defined a priori regions (nucleus accumbens, caudate, putamen).

  14-20 weeks after initiation of test diet

Secondary Outcomes (2)

• Blood flow to the hypothalamus

  14-20 weeks after initiation of test diet

• Functional connectivity between the hypothalamus and nucleus accumbens

  14-20 weeks after initiation of test diet

Study Arms (3)

Low carbohydrate diet

ACTIVE COMPARATOR

Behavioral: Low carbohydrate diet

Moderate carbohydrate diet

ACTIVE COMPARATOR

Behavioral: Moderate carbohydrate diet

High carbohydrate diet

ACTIVE COMPARATOR

Behavioral: High carbohydrate diet

Interventions

Low carbohydrate diet BEHAVIORAL

Feeding study. Composition (by proportion of calories): 20% carbohydrate, 60% fat, 20% protein

Low carbohydrate diet

Moderate carbohydrate diet BEHAVIORAL

Feeding study. Composition (by proportion of calories): 40% carbohydrate, 40% fat, 20% protein

Moderate carbohydrate diet

High carbohydrate diet BEHAVIORAL

Feeding study. Composition (by proportion of calories): 60% carbohydrate, 20% fat, 20% protein

High carbohydrate diet

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Aged 18 to 55 years
• BMI ≥ 23 kg/m2
• BMI \< 45 kg/m2 and weight ≤ 300 lbs (136 kg)
• Medical clearance from a primary care provider
• Student or employee at Framingham State University throughout enrollment in the study
• Community-based participants from the greater Framingham and Assabet Valley communities
• Willing and able to eat and drink only the foods and beverages on the study menus
• Willing to eat in the dining hall
• Willing to abstain from consuming alcohol during participation
• Body circumference of \<64 in
• Willingness to undergo 2, 30-minute MRI scans

You may not qualify if:

• Change in body weight exceeding ±10% during prior year
• Recent adherence to a special diet
• Recent adherence to a vigorous physical activity regimen (e.g., participation in a varsity sport)
• Chronic use of any medication or dietary supplement that could affect study outcomes
• Current smoking (1 cigarette in the last week)
• Heavy baseline alcohol consumption or history of binge drinking
• Physician diagnosis of a major medical/psychiatric illness or eating disorder
• Abnormal blood glucose, TSH, CBC, BUN, Creatinine
• ALT greater than 150% of the normal upper limit
• Plans for a vacation during the study that would preclude adherence to prescribed diet
• Previous bariatric surgery
• Other contraindications to MRI scanning (severe claustrophobia/extensive orthopedic hardware/pacemaker, cerebral aneurysm clip)

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Boston Children's Hospital: collaborator
• Nutrition Science Initiative: collaborator
• New Balance Foundation: collaborator
• Boston Medical Center: collaborator
• Framingham State University: collaborator

Related Publications (2)

• Lennerz BS, Alsop DC, Holsen LM, Stern E, Rojas R, Ebbeling CB, Goldstein JM, Ludwig DS. Effects of dietary glycemic index on brain regions related to reward and craving in men. Am J Clin Nutr. 2013 Sep;98(3):641-7. doi: 10.3945/ajcn.113.064113. Epub 2013 Jun 26.

  PMID: 23803881 BACKGROUND

• Holsen LM, Hoge WS, Lennerz BS, Cerit H, Hye T, Moondra P, Goldstein JM, Ebbeling CB, Ludwig DS. Diets Varying in Carbohydrate Content Differentially Alter Brain Activity in Homeostatic and Reward Regions in Adults. J Nutr. 2021 Aug 7;151(8):2465-2476. doi: 10.1093/jn/nxab090.

  PMID: 33852013 DERIVED

Related Links

• Link to the Framingham State Food Study (parent study)

MeSH Terms

Conditions

Obesity

Interventions

Diet, Carbohydrate-Restricted; Diet, High-Protein Low-Carbohydrate

Condition Hierarchy (Ancestors)

Overweight; 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; Diet, High-Protein

Study Officials

• Laura M. Holsen, Ph.D.

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychiatry

Study Record Dates

• First Submitted: November 20, 2014
• First Posted: November 25, 2014
• Study Start: November 1, 2014
• Primary Completion: April 30, 2017
• Study Completion: April 30, 2017
• Last Updated: June 6, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share