NCT03457870

Brief Summary

Extended bouts of periodic mastication and intermittent energy restriction (IER) may improve cognitive performance in the context of adult hippocampal neurogenesis in an ageing population. A randomised controlled parallel design trial will determine the impact of a 3 month IER diet (2 consecutive days of very low calorie diet and 5 days of normal eating) and a mastication intervention (1 piece of gum chewed for 10 minutes 3 times a day) in comparison to a control on neurogenesis-associated cognitive measures and circulating levels of the anti-ageing protein Klotho.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
123

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2018

Typical duration for not_applicable

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

First Submitted

Initial submission to the registry

February 23, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 8, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

April 18, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 23, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 23, 2020

Completed
Last Updated

February 18, 2021

Status Verified

February 1, 2021

Enrollment Period

1.9 years

First QC Date

February 23, 2018

Last Update Submit

February 17, 2021

Conditions

AgingCognitive Decline

Keywords

Intermittent fastingAdult hippocampal neurogenesisMasticationPattern separationRecognition memoryKlotho

Outcome Measures

Primary Outcomes (5)

  • Serum Klotho concentration

    Anti-ageing longevity protein

    Baseline

  • Serum Klotho concentration

    Anti-ageing longevity protein

    Day 42

  • Serum Klotho concentration

    Anti-ageing longevity protein

    Day 84

  • Mnemonic Similarity Task

    Neurogenesis-associated cognition

    Baseline

  • Mnemonic Similarity Task

    Neurogenesis-associated cognition

    Day 42

Secondary Outcomes (66)

  • Body weight

    Baseline

  • Body weight

    Day 42

  • Body weight

    Day 84

  • Body fat percentage

    Baseline

  • Body fat percentage

    Day 42

  • +61 more secondary outcomes

Other Outcomes (1)

  • Adverse events

    Baseline until endpoint: Day 84

Study Arms (4)

Intermittent Energy Restriction

EXPERIMENTAL

Dietary intervention: Intermittent energy restriction

Behavioral: Intermittent Energy Restriction

Chewing

EXPERIMENTAL

Mastication intervention: chewing

Behavioral: Chewing

Chewing + Intermittent Energy Restriction

EXPERIMENTAL

Dietary and mastication intervention: Intermittent energy restriction and chewing

Behavioral: Chewing + Intermittent Energy Restriction

Control

NO INTERVENTION

No intervention: Control

Interventions

Intermittent Energy RestrictionBEHAVIORAL

Dietary advice to follow a 5:2 diet.

Intermittent Energy Restriction
ChewingBEHAVIORAL

Asked to chew 1 piece of gum for 10 minutes 3 times a day.

Chewing
Chewing + Intermittent Energy RestrictionBEHAVIORAL

Dietary advice to follow a 5:2 diet. Asked to chew 1 piece of gum for 10 minutes 3 times a day.

Chewing + Intermittent Energy Restriction

Eligibility Criteria

Age60 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female subjects.
  • + years of age at the time of consent.
  • BMI 25-35.

You may not qualify if:

  • Subject is unable to understand the participant information sheet.
  • Subject is unable to understand and/or completely perform the cognitive testing.
  • Chews more than 3 sticks of gum per month, including nicotine replacement gum.
  • Unable to provide written informed consent.
  • Impaired vision that is not corrected.
  • Does not agree to maintain their habitual exercise routine.
  • Is not in general good health on the basis of medical history.
  • Unwilling to chew gum for 3 times a day for 12 weeks.
  • Unwilling to maintain an intermittent fasting diet regime.
  • Unwilling to have blood taken.
  • History of or are currently diagnosed with a significant psychiatric disorder (e.g. schizophrenia, anxiety, PTSD).
  • Subject has any neurological disorder that could produce cognitive deterioration (e.g. Alzheimer's disease, Parkinson's disease, stroke).
  • History of traumatic brain injury, stroke or any other medical conditions causing cognitive impairment.
  • Has uncontrolled epilepsy or is prone to fainting.
  • Participated in a weight management drug trial in previous 3 months.
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Diabetes & Nutritional Sciences Division, King's College London, Franklin-Wilkins Building, 150 Stamford St

London, England, SE1 9NH, United Kingdom

Location

Related Publications (4)

  • Murphy T, Dias GP, Thuret S. Effects of diet on brain plasticity in animal and human studies: mind the gap. Neural Plast. 2014;2014:563160. doi: 10.1155/2014/563160. Epub 2014 May 12.

    PMID: 24900924BACKGROUND

  • Witte AV, Fobker M, Gellner R, Knecht S, Floel A. Caloric restriction improves memory in elderly humans. Proc Natl Acad Sci U S A. 2009 Jan 27;106(4):1255-60. doi: 10.1073/pnas.0808587106. Epub 2009 Jan 26.

    PMID: 19171901BACKGROUND

  • Akazawa Y, Kitamura T, Fujihara Y, Yoshimura Y, Mitome M, Hasegawa T. Forced mastication increases survival of adult neural stem cells in the hippocampal dentate gyrus. Int J Mol Med. 2013 Feb;31(2):307-14. doi: 10.3892/ijmm.2012.1217. Epub 2012 Dec 18.

    PMID: 23254518BACKGROUND

  • Smith, N., Miquel-Kergoat, S. & Thuret, S., 2016. The impact of mastication on cognition: Evidence for intervention and the role of adult hippocampal neurogenesis. Nutrition and Aging, 3(2-4), pp.115-123

    BACKGROUND

MeSH Terms

Conditions

Cognitive DysfunctionIntermittent Fasting

Interventions

Mastication

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersFastingFeeding BehaviorBehavior

Intervention Hierarchy (Ancestors)

EatingNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaDigestive System Physiological PhenomenaDigestive System and Oral Physiological Phenomena

Study Officials

  • Sandrine Thuret, PhD

    King's College London

    PRINCIPAL INVESTIGATOR

  • Wendy L Hall, PhD

    King's College London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2018

First Posted

March 8, 2018

Study Start

April 18, 2018

Primary Completion

March 23, 2020

Study Completion

March 23, 2020

Last Updated

February 18, 2021

Record last verified: 2021-02

Locations

GB(1)