Photobiomodulation & Ketogenic Diet for Treatment of Mid-periphery Retinal Disorders for Alzheimer's Disease Prevention

NCT03859245 | Unknown DMC

• 1 other identifier: Bristlecone-002
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The study will explore the impact of photobiomodulation (PBM), pulsating at frequencies of red (660nm) and near-infrared (810nm)(NIR), concurrent with a ketogenic dietary protocol (serum ketones @ .5 - 2.0 mmol/L) to mediate vascular features of diabetic retinopathy (DR), diabetic macular edema (DME), age-related macular degeneration (AMD), mid-peripheral drusens, visual acuity and retinal disorders. Red and near-infrared light via light-emitting diode (LED) treatment promotes retinal healing and improves visual acuity by augmenting cellular energy metabolism, enhancing mitochondrial function, increasing cytochrome C oxidase activity, stimulating antioxidant protective pathways and promoting cell survival. LED therapy directly benefits neurons in the retina, the lateral geniculate nucleus and the visual cortex; likewise, a ketogenic dietary protocol shows metabolic and neuro-modulatory benefits within the CNS, most notably as treatment for refractory epilepsy. Photobiomodulation has been approved as a non-significant risk (NSR) modality for the treatment of eye disorders.

Conditions

Diabetic Retinopathy (DR); Age-related Macular Degeneration (AMD); Mid-peripheral Drusen Formation; Diabetic Macular Edema (DME)

Keywords

Photobiomodulation; Diabetic Retinopathy (DR); Age-related Macular Degeneration (AMD); Mid-peripheral Drusen; Alzheimer's disease (AD); Ketogenic Diet (KD)

Outcome Measures

Primary Outcomes (4)

• Diabetic Retinopathy (DR) pathology

  Improvement in number and severity of hemorrhages and hard and soft exudates as measured by the Daytona Plus (Panoramic Ophthalmoscope P200T)

  36 weeks

• Diabetic Macular Edema (DME) pathology

  Lower incidence of macular edema as measured by Optos Daytona Plus (Panoramic Ophthalmoscope P200T) and Optovue XR Avanti 3 OCT (Ocular Coherence Tomography) Imaging Systems

  36 weeks

• Dry Age-related Macular Degeneration (AMD) pathology

  Reduction in size and number of drusen in early and intermediate stages of Dry AMD pathology as measured byOptos Daytona Plus (Panoramic Ophthalmoscope P200T) and Optovue XR Avanti 3 OCT (Ocular Coherence Tomography) Imaging Systems

  36 weeks

• Hard Drusen in the Mid-periphery pathology

  Reduction in size and/or density of drusen as measured by the Optos Daytona Plus (Panoramic Ophthalmoscope P200T)

  36 weeks

Secondary Outcomes (5)

• HgA1c

  36 weeks

• Fasting Insulin

  36 weeks

• Fasting Glucose

  36 weeks

• HOMA-IR

  36 weeks

• Triglycerides/HDL ratio

  36 weeks

Study Arms (2)

Experimental group

EXPERIMENTAL

Subjects in the experimental group will receive clinically prescribed meal plans designed to facilitate prolonged benign dietary ketosis (BDK) purposed at glucose regulation, improved insulin sensitivity and restored metabolic flexibility. Photobiomodulation therapy, via Joovv red light/infrared LED device, will be administered three times per week, 20 minutes per session.

Behavioral: Photobiomodulation; Behavioral: Ketogenic diet

Control group

ACTIVE COMPARATOR

Subjects in the control group will follow current dietary protocol (Standard American Diet- SAD). Photobiomodulation therapy,via Joovv red light/infrared LED device, will be administered three times per week, 20 minutes per session.

Behavioral: Photobiomodulation

Interventions

Photobiomodulation BEHAVIORAL

Photobiomodulation therapy, via Joovv red light/infrared LED device, three days/week, 20 minutes per session for experimental and control groups.

Control group; Experimental group

Ketogenic diet BEHAVIORAL

Experimental group will follow a clinically prescribed ketogenic diet.

Experimental group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or Female (age 18-80)
• Previously diagnosed with MetS and/or T2DM as measured by possessing at least 2 of the following physiological measures: type II diabetes, BMI \>30, HgA1c \> 5.7, waist/height ratio \>.6, fasting glucose \> 125
• Previously diagnosed with at least one of the following: mid-peripheral drusen formation, diabetic retinopathy (DR), age-related macular degeneration (AMD) or diabetic macular edema

You may not qualify if:

• Previously diagnosed with Alzheimer's disease (AD), dementia or Parkinson's disease

Sponsors & Collaborators

• Bristlecone Health, Inc.: lead
• University of Minnesota: collaborator

Study Sites (1)

Yankee Eye Clinic

Eagan, Minnesota, 55123, United States

RECRUITING

MeSH Terms

Conditions

Diabetic Retinopathy; Macular Degeneration; Alzheimer Disease

Interventions

Low-Level Light Therapy; Diet, Ketogenic

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Retinal Degeneration; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy; Diet, Carbohydrate-Restricted; Diet Therapy; Nutrition Therapy; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Central Study Contacts

Kelly Gibas, Doctorate

CONTACT

763-913-4600; kgibas@bristleconemedical.com

Julie Gomer, Doctorate

CONTACT

763-913-4600; jgomer@bristleconemedical.com

Study Design

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

Model Details: To assess differences between the control and experimental groups, a mixed model will be fit for each variable separately using both baseline (week 0) and post program (week 36) values for each subject. Models will include week, group, and their interaction as fixed effects, gender as a covariate, and subject as random effect. To assess significant differences, we will use the difference at week 36 adjusted for the baseline difference, report p-values, least squares mean, and 95% confidence intervals. Further analysis of treatment effects over time will be examined by comparing the within-group differences over time.

Study Record Dates

• First Submitted: February 24, 2019
• First Posted: March 1, 2019
• Study Start: February 23, 2019
• Primary Completion: September 30, 2020
• Study Completion: September 30, 2020
• Last Updated: March 4, 2019

Record last verified: 2019-02

Locations

US (1)