Effect of a Modified Ketogenic-Mediterranean Diet on Alzheimer's Disease

NCT02984540 | Completed DMC

• 1 other identifier: IRB00029992
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the BEAM study is to compare the effects of a low-carbohydrate diet and a lowfat diet for adults with mild memory loss and adults with pre-diabetes. The data collected will help determine changes in cognitive function, brain structure and function, and levels of certain proteins and hormones in body fluids.

Conditions

Mild Cognitive Impairment; Insulin Resistance

Outcome Measures

Primary Outcomes (1)

• Change in spinal fluid levels of biomarkers associated with Alzheimer's disease

  Baseline CSF measures will be compared to measures obtained six weeks after the initiation of the ketogenic diet and six weeks after initiation of the American Heart Association Diet

Secondary Outcomes (3)

• Change in memory composite score

  Baseline cognitive measures will be compared to measures obtained six weeks after the initiation of the ketogenic diet and six weeks after initiation of the American Heart Association Diet

• Change in insulin sensitivity

  Baseline metabolic measures will be compared to measures obtained six weeks after the initiation of the ketogenic diet and six weeks after initiation of the American Heart Association Diet

• change in 11C acetoacetate PET uptake

  Baseline acetoacetate uptake will be compared to measures obtained six weeks after the initiation of the ketogenic diet and six weeks after initiation of the American Heart Association Diet

Study Arms (2)

LOW-CARBOHYDRATE DIET

EXPERIMENTAL

The low-carbohydrate diet will consist of a meal plan of less than 20 grams of carbohydrates per day to be consumed over 6 weeks. Foods that provide high levels of healthy fats (preferably low in saturated fats) will be generously included in the diet plan. Various lean meats, fish, and nutrient rich foods that meet the requirement of less than 20 grams total carbohydrates per day will be included in the meal plans. Carbohydrates will be expected to make up less than 10% of total caloric intake. Participants in the low-carbohydrate diet group will receive a supply of extra virgin olive oil at study visits to incorporate into their individualized meal plans.

Other: Low-Carbohydrate Diet

LOW-FAT DIET

EXPERIMENTAL

The low-fat diet will consist of a low-fat, higher-carbohydrate meal plan to be consumed over 6 weeks. Participants will be encouraged to limit their amount of fat intake to less than 40 grams per day, while eating plentiful fruits, vegetables, and carbohydrates containing adequate fiber. Various lean meats and other sources of protein will be included in the diet plan. Carbohydrates will be expected to make up 50-60% of total caloric intake.

Other: Low-Fat Diet

Interventions

Low-Carbohydrate Diet OTHER

Participants assigned to the Modified Ketogenic-Mediterranean Diet will keep their carbohydrate consumption below 20 grams per day throughout the 6-week intervention.

LOW-CARBOHYDRATE DIET

Low-Fat Diet OTHER

Participants assigned to the Low-Fat Diet will be encouraged to limit their amount of fat intake to \<40 grams/day, while eating plentiful fruits, vegetables, and carbohydrates containing adequate fiber.

LOW-FAT DIET

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or post-menopausal female;
• Age 50 to 85 years inclusive;
• Cognitive diagnosis ranged from cognitively normal for "'Healthy' and 'At-Risk'" to mild/moderate cognitive impairment for "MCI/eAD;"
• Stable medical condition (generally 3 months prior to screening visit) at the discretion of study physician;
• Stable on medications (generally 4 weeks prior to screening visit) at the discretion of study physician;
• Able to complete baseline assessments;
• HbA1c and fasting glucose within the normal (Healthy or MCI/eAD) or pre-diabetic (At-Risk or MCI/eAD) range depending on group.

You may not qualify if:

• Diagnosis of neurodegenerative illness (except for MCI or early AD in the MCI/eAD group);
• History of a clinically significant stroke;
• Current evidence or history in past year of focal brain lesion, head injury with loss of consciousness or DSM-IV criteria for any major psychiatric disorder including psychosis, major depression, bipolar disorder, alcohol or substance abuse;
• Sensory impairment (i.e.: visual or auditory) that would preclude the participant from participating in the protocol;
• Diabetes that requires current use of diabetes medications;
• Current use of cholesterol/lipid lowering medications;
• Clinically significant elevations in liver function tests;
• Active neoplastic disease (stable prostate cancer and non-melanoma skin cancer is permissible);
• History of epilepsy or seizure within past year;
• Contraindications for MRI (claustrophobia, craniofacial metal implants, pacemakers);
• Significant medical illness or organ failure, such as uncontrolled hypertension or cardiovascular disease, chronic obstructive pulmonary disease, liver disease, or kidney disease;
• Use of the following medications: anticonvulsants, drugs with potential interfering CNS effects (other than cholinesterase inhibitors or memantine), medications with significant anticholinergic activity, anti-parkinsonian medications or regular use of narcotic analgesics;
• If female, menstruation in the past 12 months or hysterectomy and current hormone replacement therapy medication;
• Major digestive disorders, absorption issues, or surgeries that may be exacerbated by diet changes;
• Untreated hypothyroidism or B12 deficiency;

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest Baptist Health

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (1)

• Brinkley TE, Leng I, Register TC, Neth BJ, Zetterberg H, Blennow K, Craft S. Changes in Adiposity and Cerebrospinal Fluid Biomarkers Following a Modified Mediterranean Ketogenic Diet in Older Adults at Risk for Alzheimer's Disease. Front Neurosci. 2022 Jun 2;16:906539. doi: 10.3389/fnins.2022.906539. eCollection 2022.

  PMID: 35720727 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction; Insulin Resistance

Interventions

Diet, Carbohydrate-Restricted; Diet, Fat-Restricted

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Suzanne Craft, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2016
• First Posted: December 7, 2016
• Study Start: February 1, 2015
• Primary Completion: April 3, 2017
• Study Completion: April 3, 2017
• Last Updated: July 28, 2025

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)