NCT02681081

Brief Summary

The purpose of the study is to identify non-invasive strategies that will optimize the neurobiological environment and improve learning and memory in the treatment of chronic pain. The overall aims of the current proposal are to determine if food restriction and/or glucose administration in conjunction with a relaxation/guided imagery exercise will result in neurophysiological changes and functional improvements compared to the relaxation/guided imagery exercise alone.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable pain

Timeline
Completed

Started Feb 2016

Longer than P75 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

February 2, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 12, 2016

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 12, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 12, 2019

Completed
Last Updated

July 15, 2019

Status Verified

July 1, 2019

Enrollment Period

3.4 years

First QC Date

February 2, 2016

Last Update Submit

July 12, 2019

Conditions

PainOsteoarthritis

Keywords

Neuroplasticity

Outcome Measures

Primary Outcomes (1)

  • Change in Neurophysiological measures

    Electroencephalogram (EEG) amplitude measures.

    baseline and 3 weeks

Secondary Outcomes (4)

  • Change in Clinical Pain measure - Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

    baseline and 3 weeks

  • Change in Experimental Pain measure - Temporal summation of punctate mechanical stimuli

    baseline and 3 weeks

  • Change in Level of Distress measure - Perceived Stress Scale

    baseline and 3 weeks

  • Change in Affect Measure - Positive and Negative Affect Schedule (PANAS)

    baseline and 3 weeks

Other Outcomes (1)

  • Change in Recall and Recognition measures - Hopkins Verbal Learning Test (HVLT)

    baseline and 3 weeks

Study Arms (3)

Control

OTHER

For sessions 2 through 4, maintain normal eating patterns.

Other: Control

Glucose Administration

ACTIVE COMPARATOR

For sessions 2 through 4, participants will fast for two hours prior to each session and consume 25-30 g of glucose at the start of each session.

Other: Glucose Administration

Intermittent Fasting

ACTIVE COMPARATOR

For sessions 2 through 4, participants will fast for 16 hours prior to the session (no food or beverages other than non-caloric beverages or coffee after 6 or 7 pm the evening prior).

Other: Intermittent Fasting

Interventions

Glucose AdministrationOTHER

For sessions 2 through 4, participants will fast for two hours prior to each session and consume 25-30 g of glucose at the start of each session.

Glucose Administration
Intermittent FastingOTHER

For sessions 2 through 4, participants will fast for 16 hours prior to the session (no food or beverages other than non-caloric beverages or coffee after 6 or 7 pm the evening prior).

Intermittent Fasting
ControlOTHER

Normal food intake

Control

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults with chronic knee pain with or/at risk of knee osteoarthritis

You may not qualify if:

  • Concurrent medical condition that could confound outcome measures or limit the ability to participate completely in the protocol including: neurological conditions (Parkinson's disease, multiple sclerosis, and/or seizures)
  • History of a head injury or stroke
  • Diabetes or taking medications to control blood sugar
  • Mental health issues resulting in hospitalization or outpatient treatment in the past year, and/or psychotropic medication use
  • Current issue or history of treatment for alcohol or other substance abuse
  • Cognitive function \< or = 22 on the Mini-Mental Status Exam
  • Pregnancy
  • A baseline fasting blood sugar (plasma glucose \> 7mmol/L) or persisting blood pressure \>150/95.
  • Heart condition such as a prior heart attack, heart surgery (including a stent), frequent chest pain or heart failure
  • Inability to complete the EEG portion of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Aging

Gainesville, Florida, 32611, United States

Location

Related Publications (5)

  • Smith MA, Riby LM, Eekelen JA, Foster JK. Glucose enhancement of human memory: a comprehensive research review of the glucose memory facilitation effect. Neurosci Biobehav Rev. 2011 Jan;35(3):770-83. doi: 10.1016/j.neubiorev.2010.09.008. Epub 2010 Sep 29.

    PMID: 20883717BACKGROUND

  • Hensch TK, Bilimoria PM. Re-opening Windows: Manipulating Critical Periods for Brain Development. Cerebrum. 2012 Jul;2012:11. Epub 2012 Aug 29.

    PMID: 23447797BACKGROUND

  • Martin B, Mattson MP, Maudsley S. Caloric restriction and intermittent fasting: two potential diets for successful brain aging. Ageing Res Rev. 2006 Aug;5(3):332-53. doi: 10.1016/j.arr.2006.04.002. Epub 2006 Aug 8.

    PMID: 16899414BACKGROUND

  • Cramer SC, Sur M, Dobkin BH, O'Brien C, Sanger TD, Trojanowski JQ, Rumsey JM, Hicks R, Cameron J, Chen D, Chen WG, Cohen LG, deCharms C, Duffy CJ, Eden GF, Fetz EE, Filart R, Freund M, Grant SJ, Haber S, Kalivas PW, Kolb B, Kramer AF, Lynch M, Mayberg HS, McQuillen PS, Nitkin R, Pascual-Leone A, Reuter-Lorenz P, Schiff N, Sharma A, Shekim L, Stryker M, Sullivan EV, Vinogradov S. Harnessing neuroplasticity for clinical applications. Brain. 2011 Jun;134(Pt 6):1591-609. doi: 10.1093/brain/awr039. Epub 2011 Apr 10.

    PMID: 21482550BACKGROUND

  • Sibille KT, Bartsch F, Reddy D, Fillingim RB, Keil A. Increasing Neuroplasticity to Bolster Chronic Pain Treatment: A Role for Intermittent Fasting and Glucose Administration? J Pain. 2016 Mar;17(3):275-81. doi: 10.1016/j.jpain.2015.11.002. Epub 2016 Feb 2.

    PMID: 26848123BACKGROUND

MeSH Terms

Conditions

PainOsteoarthritis

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Kimberly T Sibille, PhD

    University of Florida

    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
SPONSOR

Study Record Dates

First Submitted

February 2, 2016

First Posted

February 12, 2016

Study Start

February 1, 2016

Primary Completion

July 12, 2019

Study Completion

July 12, 2019

Last Updated

July 15, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)