AgingChANgENCT03457870
Intermittent Energy Restriction and Chewing on Neural Stem Cell Ageing and Adult Hippocampal Neurogenesis Associated Cognition
A study testing Intermittent Energy Restriction, Chewing and Chewing + Intermittent Energy Restriction in people with Aging and Cognitive Decline, run by King's College London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Aging, Cognitive Decline
- What is being tested?
- Intermittent Energy Restriction, Chewing and Chewing + Intermittent Energy Restriction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 18 Apr 2018to 23 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female subjects.
- 60+ years of age at the time of consent.
- BMI 25-35.
Who cannot join
- 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.
Show all 22Show fewer
- 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.
- Has undergone bariatric surgery.
- Known or suspected of alcohol abuse defined as >14 drinks per week (1 drink = 1 pint of beer, 1 large glass of wine or 50ml spirit).
- Gastrointestinal or liver disease.
- Subject has a sleep disorder or an occupation where sleep during the overnight hours is irregular.
- Subjects taking the following prescription medications: Donepezil (Aricept), Galantamine (Reminyl), Rivastigmine (Exelon), Tacrine (Cognex), Bethanechol (Urecholine), Memantine (Namenda) Selegiline (Eldepryl) or any other medication for cognitive impairment.
- Subject has a known sensitivity to the study product.
- Individual has a condition the chief investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, might confound the interpretation of study results or put the subject at undue risk.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Diabetes & Nutritional Sciences Division, King's College London, Franklin-Wilkins Building, 150 Stamford St
London, England, SE1 9NH
About this study
Official title: Investigating the Impact of Intermittent Energy Restriction and Chewing on Neural Stem Cell Ageing and Adult Hippocampal Neurogenesis: The ChANgE Study
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.
Read the detailed description
Nutrition and human health are strongly related. Altering overabundance through fasting/calorie-restricted diets has profound effects on homeostasis, tissue regeneration, and cancer. Tissue stem cells respond to the physiological changes that occur during fasting through dynamic shifts in their metabolism. Restricting energy intake in mice or introducing mutations in nutrient-sensing pathways can extend lifespans by as much as 50%. Post-mortems reveal that tumours, heart problems, neurodegeneration and metabolic disease are generally reduced/delayed in long-lived mice. Therefore, extending lifespan by energy restriction (ER) also seems to increase 'healthspan', the time lived without chronic age-related conditions. These insights have hardly made a dent in human medicine. Molecular and cellular insights should be established in humans to validate interventions such as ER to delay ageing and associated conditions e.g. cognitive decline (Murphy et al., 2014).
Stem cells from the central nervous system also respond to ER. Recently, the Thuret lab have found that ER, in the absence of malnutrition, promotes hippocampal stem cells to proliferate and differentiate into new-born neurons. Because these new postnatal hippocampal neurons have been shown to play a role in cognition, ER also promoted enhanced cognition in rodents (Zainuddin et al., 2012; de Lucia et al., 2017; Thuret et al., 2012). This phenomenon of neurogenesis, the process by which new neurons are generated from neural stem cells, is also occurring in humans (Spalding et al., 2013). It is a tightly regulated process occurring in the mammalian hippocampus which is an environmentally responsive brain structure known to regulate learning, memory and mood. Proposed functions of adult hippocampal neurogenesis (AHN). include enhancing recognition memory, the ability to recognise previously encountered stimuli, and pattern separation, the ability to differentially encode small changes in similar inputs (Clelland et alk., 2009; Sahay et al., 2011). It has been posited that calorie restriction may increase neurogenesis as a "cellular relic" of intermittent feeding patterns during evolution as a response to alternating periods of famine and abundant food (Murphy \& Thuret, 2015). Human trials have found significant improvements in verbal recognition memory after 30% reduction in calorie intake (Witte et al., 2009). Also, intermittent fasting in humans has been associated with significant increases in brain activation volume in areas involved in brain function control and plasticity(Belaïch et al., 2016). Food texture and mastication have also been implicated in AHN and cognitive ability (Smith et al., 2016). Decreased mastication due to the removal of molars and edentulism in both humans and animals have a negative impact on AHN and associated cognition. Human populations, in particular, have shown a close association between masticatory function, cognitive status and age-related neurodegeneration in the elderly (Miura et al., 2003). The exact mechanism by which mastication affects cognition is unknown.
Research question: In older, overweight participants does IER and/or extended periods of mastication enhance performance inhippocampus-dependent memory tasks and increase anti-ageing marker Klotho?
Objectives:
- A randomised controlled parallel-design trial will determine the impact of an IER diet (2 consecutive days of a very low calorie diet, 5 days of normal healthy eating for 3 months) and/or extended periods of mastication (10 minutes 3 times a day for 3 months) compared to a control group (continued habitual eating behaviour, dietary patterns) on primary outcome variables (MST and Klotho) in older, healthy participants with overweight or class I obesity.
- To assess the impact of an IER diet and extended periods of mastication on secondary outcomes variables including body composition, mood and sleep.
- To explore whether extended periods of mastication can be utilised as a weight loss/fasting aid.
- Conditions
- Aging, Cognitive Decline
- Being tested
- Intermittent Energy Restriction, Chewing, Chewing + Intermittent Energy Restriction
- Keywords
- Intermittent fasting, Adult hippocampal neurogenesis, Mastication, Pattern separation, Recognition memory, Klotho
- Medical subject headings
- Cognitive Dysfunction, Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent Energy RestrictionBehavioural
Dietary advice to follow a 5:2 diet.
ChewingBehavioural
Asked to chew 1 piece of gum for 10 minutes 3 times a day.
Chewing + Intermittent Energy RestrictionBehavioural
Dietary advice to follow a 5:2 diet. Asked to chew 1 piece of gum for 10 minutes 3 times a day.
| Study group | Role | What they receive |
|---|---|---|
| Intermittent Energy Restriction | Experimental | Dietary intervention: Intermittent energy restriction Receives: Behavioral: Intermittent Energy Restriction |
| Chewing | Experimental | Mastication intervention: chewing Receives: Behavioral: Chewing |
| Chewing + Intermittent Energy Restriction | Experimental | Dietary and mastication intervention: Intermittent energy restriction and chewing Receives: Behavioral: Chewing + Intermittent Energy Restriction |
| Control | No intervention | No intervention: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Klotho concentration
Anti-ageing longevity protein
Measured: Baseline
Serum Klotho concentration
Anti-ageing longevity protein
Measured: Day 42
Serum Klotho concentration
Anti-ageing longevity protein
Measured: Day 84
Mnemonic Similarity Task
Neurogenesis-associated cognition
Measured: Baseline
Mnemonic Similarity Task
Neurogenesis-associated cognition
Measured: Day 42
Secondary outcomes (66)
Body weight
Measured: Baseline
Body weight
Measured: Day 42
Body weight
Measured: Day 84
Body fat percentage
Measured: Baseline
Body fat percentage
Measured: Day 42
Body fat percentage
Measured: Day 84
Body Mass Index
Measured: Baseline
Body Mass Index
Measured: Day 42
Body Mass Index
Measured: Day 84
Waist circumference
Measured: Baseline
Waist circumference
Measured: Day 42
Waist circumference
Measured: Day 84
Hip circumference
Measured: Baseline
Hip circumference
Measured: Day 42
Hip circumference
Measured: Day 84
Patient Health Questionnaire
Questionnaire
Measured: Baseline
Patient Health Questionnaire
Questionnaire
Measured: Day 42
Patient Health Questionnaire
Questionnaire
Measured: Day 84
Zung Self-Rating Anxiety Scale
Questionnaire - Scale can be scored from 20 (normal) to 80 (extreme anxiety levels). The total score is reported.
Measured: Baseline
Zung Self-Rating Anxiety Scale
Questionnaire
Measured: Day 42
Zung Self-Rating Anxiety Scale
Questionnaire
Measured: Day 84
Pittsburgh Sleep Quality Index
Questionnaire
Measured: Baseline
Pittsburgh Sleep Quality Index
Questionnaire
Measured: Day 42
Pittsburgh Sleep Quality Index
Questionnaire
Measured: Day 84
Plasma glucose concentration
Fasting
Measured: Baseline
Plasma glucose concentration
Fasting
Measured: Day 42
Plasma glucose concentration
Fasting
Measured: Day 84
Cholesterol
Fasting
Measured: Baseline
Cholesterol
Fasting
Measured: Day 42
Cholesterol
Fasting
Measured: Day 84
Triglycerides
Fasting
Measured: Baseline
Triglycerides
Fasting
Measured: Day 42
Triglycerides
Fasting
Measured: Day 84
High Density Lipoprotein
Fasting
Measured: Baseline
High Density Lipoprotein
Fasting
Measured: Day 42
High Density Lipoprotein
Fasting
Measured: Day 84
Low Density Lipoprotein
Fasting
Measured: Baseline
Low Density Lipoprotein
Fasting
Measured: Day 42
Low Density Lipoprotein
Fasting
Measured: Day 84
Total/HDL Cholesterol Ratio
Fasting
Measured: Baseline
Total/HDL Cholesterol Ratio
Fasting
Measured: Day 42
Total/HDL Cholesterol Ratio
Fasting
Measured: Day 84
Plasma adiponectin concentration
Fasting
Measured: Baseline
Plasma adiponectin concentration
Fasting
Measured: Day 42
Plasma adiponectin concentration
Fasting
Measured: Day 84
Plasma leptin concentration
Fasting
Measured: Baseline
Plasma leptin concentration
Fasting
Measured: Day 42
Plasma leptin concentration
Fasting
Measured: Day 84
Plasma beta-hydroxybutrate concentration
Fasting
Measured: Baseline
Plasma beta-hydroxybutrate concentration
Fasting
Measured: Day 42
Plasma beta-hydroxybutrate concentration
Fasting
Measured: Day 84
Plasma total cholesterol concentration
Fasting
Measured: Baseline
Plasma total cholesterol concentration
Fasting
Measured: Day 42
Plasma total cholesterol concentration
Fasting
Measured: Day 84
Plasma low density lipoprotein (LDL) cholesterol concentration
Fasting
Measured: Baseline
Plasma LDL cholesterol concentration
Fasting
Measured: Day 42
Plasma LDL cholesterol concentration
Fasting
Measured: Day 84
Plasma high density lipoprotein (HDL) cholesterol concentration
Fasting
Measured: Baseline
Plasma HDL cholesterol concentration
Fasting
Measured: Day 42
Plasma HDL cholesterol concentration
Fasting
Measured: Day 84
Plasma triglyceride concentration
Fasting
Measured: Baseline
Plasma triglyceride concentration
Fasting
Measured: Day 42
Plasma triglyceride concentration
Fasting
Measured: Day 84
Plasma total cholesterol:HDL cholesterol ratio
Fasting
Measured: Baseline
Plasma total cholesterol:HDL cholesterol ratio
Fasting
Measured: Day 42
Plasma total cholesterol:HDL cholesterol ratio
Fasting
Measured: Day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2018
- Study start18 Apr 2018
- Primary completion23 Mar 2020
- Study completion23 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Council, Mars, Inc.
- Responsible party
- Sponsor
- Investigators
- Sandrine Thuret, PhD, Principal investigator, King's College LondonWendy L Hall, PhD, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03457870
- Sponsor's protocol ID
- Change 2018
- Acronym
- ChANgE
- Status last verified
- Feb 2021
- First submitted
- 23 Feb 2018
- Last updated
- 18 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 24900924Witte 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.
PubMed 19171901Akazawa 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.
PubMed 23254518Smith, 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
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Impact of Intermittent Energy Restriction and Chewing on Neural Stem Cell Ageing and Adult Hippocampal Neurogenesis: The ChANgE Study
- ClinicalTrials.gov ID
- NCT03457870
- Acronym / sponsor ID
- ChANgE / Change 2018
- Conditions
- Aging, Cognitive Decline
- Keywords
- Intermittent fasting, Adult hippocampal neurogenesis, Mastication, Pattern separation, Recognition memory, Klotho
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- Medical Research Council, Mars, Inc.
- Study start
- 18 Apr 2018 (actual)
- Primary completion
- 23 Mar 2020 (actual)
- Study completion
- 23 Mar 2020 (actual)
- First posted
- 8 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Nutrition and human health are strongly related. Altering overabundance through fasting/calorie-restricted diets has profound effects on homeostasis, tissue regeneration, and cancer. Tissue stem cells respond to the physiological changes that occur during fasting through dynamic shifts in their metabolism. Restricting energy intake in mice or introducing mutations in nutrient-sensing pathways can extend lifespans by as much as 50%. Post-mortems reveal that tumours, heart problems, neurodegeneration and metabolic disease are generally reduced/delayed in long-lived mice. Therefore, extending lifespan by energy restriction (ER) also seems to increase 'healthspan', the time lived without chronic age-related conditions. These insights have hardly made a dent in human medicine. Molecular and cellular insights should be established in humans to validate interventions such as ER to delay ageing and associated conditions e.g. cognitive decline (Murphy et al., 2014).
Stem cells from the central nervous system also respond to ER. Recently, the Thuret lab have found that ER, in the absence of malnutrition, promotes hippocampal stem cells to proliferate and differentiate into new-born neurons. Because these new postnatal hippocampal neurons have been shown to play a role in cognition, ER also promoted enhanced cognition in rodents (Zainuddin et al., 2012; de Lucia et al., 2017; Thuret et al., 2012). This phenomenon of neurogenesis, the process by which new neurons are generated from neural stem cells, is also occurring in humans (Spalding et al., 2013). It is a tightly regulated process occurring in the mammalian hippocampus which is an environmentally responsive brain structure known to regulate learning, memory and mood. Proposed functions of adult hippocampal neurogenesis (AHN). include enhancing recognition memory, the ability to recognise previously encountered stimuli, and pattern separation, the ability to differentially encode small changes in similar inputs (Clelland et alk., 2009; Sahay et al., 2011). It has been posited that calorie restriction may increase neurogenesis as a "cellular relic" of intermittent feeding patterns during evolution as a response to alternating periods of famine and abundant food (Murphy \& Thuret, 2015). Human trials have found significant improvements in verbal recognition memory after 30% reduction in calorie intake (Witte et al., 2009). Also, intermittent fasting in humans has been associated with significant increases in brain activation volume in areas involved in brain function control and plasticity(Belaïch et al., 2016). Food texture and mastication have also been implicated in AHN and cognitive ability (Smith et al., 2016). Decreased mastication due to the removal of molars and edentulism in both humans and animals have a negative impact on AHN and associated cognition. Human populations, in particular, have shown a close association between masticatory function, cognitive status and age-related neurodegeneration in the elderly (Miura et al., 2003). The exact mechanism by which mastication affects cognition is unknown.
Research question: In older, overweight participants does IER and/or extended periods of mastication enhance performance inhippocampus-dependent memory tasks and increase anti-ageing marker Klotho?
Objectives:
- A randomised controlled parallel-design trial will determine the impact of an IER diet (2 consecutive days of a very low calorie diet, 5 days of normal healthy eating for 3 months) and/or extended periods of mastication (10 minutes 3 times a day for 3 months) compared to a control group (continued habitual eating behaviour, dietary patterns) on primary outcome variables (MST and Klotho) in older, healthy participants with overweight or class I obesity.
- To assess the impact of an IER diet and extended periods of mastication on secondary outcomes variables including body composition, mood and sleep.
- To explore whether extended periods of mastication can be utilised as a weight loss/fasting aid.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Intermittent Energy Restriction | Experimental | Behavioral: Intermittent Energy RestrictionDietary intervention: Intermittent energy restriction |
| Chewing | Experimental | Behavioral: ChewingMastication intervention: chewing |
| Chewing + Intermittent Energy Restriction | Experimental | Behavioral: Chewing + Intermittent Energy RestrictionDietary and mastication intervention: Intermittent energy restriction and chewing |
| Control | No intervention | –No intervention: Control |
Who may qualify
- Ages
- 60 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male and female subjects.
- 60+ years of age at the time of consent.
- BMI 25-35.
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intermittent Energy RestrictionDietary advice to follow a 5:2 diet. | Behavioural | Intermittent Energy Restriction |
| ChewingAsked to chew 1 piece of gum for 10 minutes 3 times a day. | Behavioural | Chewing |
| Chewing + Intermittent Energy RestrictionDietary advice to follow a 5:2 diet. Asked to chew 1 piece of gum for 10 minutes 3 times a day. | Behavioural | Chewing + Intermittent Energy Restriction |
Primary outcome
Serum Klotho concentration
Time frame: Baseline
Anti-ageing longevity protein
Serum Klotho concentration
Time frame: Day 42
Anti-ageing longevity protein
Serum Klotho concentration
Time frame: Day 84
Anti-ageing longevity protein
Mnemonic Similarity Task
Time frame: Baseline
Neurogenesis-associated cognition
Mnemonic Similarity Task
Time frame: Day 42
Neurogenesis-associated cognition
66 secondary outcomes
Body weight
Time frame: Baseline
Body weight
Time frame: Day 42
Body weight
Time frame: Day 84
Body fat percentage
Time frame: Baseline
Body fat percentage
Time frame: Day 42
Body fat percentage
Time frame: Day 84
Body Mass Index
Time frame: Baseline
Body Mass Index
Time frame: Day 42
Body Mass Index
Time frame: Day 84
Waist circumference
Time frame: Baseline
Waist circumference
Time frame: Day 42
Waist circumference
Time frame: Day 84
Hip circumference
Time frame: Baseline
Hip circumference
Time frame: Day 42
Hip circumference
Time frame: Day 84
Patient Health Questionnaire
Time frame: Baseline
Patient Health Questionnaire
Time frame: Day 42
Patient Health Questionnaire
Time frame: Day 84
Zung Self-Rating Anxiety Scale
Time frame: Baseline
Zung Self-Rating Anxiety Scale
Time frame: Day 42
Zung Self-Rating Anxiety Scale
Time frame: Day 84
Pittsburgh Sleep Quality Index
Time frame: Baseline
Pittsburgh Sleep Quality Index
Time frame: Day 42
Pittsburgh Sleep Quality Index
Time frame: Day 84
Plasma glucose concentration
Time frame: Baseline
Plasma glucose concentration
Time frame: Day 42
Plasma glucose concentration
Time frame: Day 84
Cholesterol
Time frame: Baseline
Cholesterol
Time frame: Day 42
Cholesterol
Time frame: Day 84
Triglycerides
Time frame: Baseline
Triglycerides
Time frame: Day 42
Triglycerides
Time frame: Day 84
High Density Lipoprotein
Time frame: Baseline
High Density Lipoprotein
Time frame: Day 42
High Density Lipoprotein
Time frame: Day 84
Low Density Lipoprotein
Time frame: Baseline
Low Density Lipoprotein
Time frame: Day 42
Low Density Lipoprotein
Time frame: Day 84
Total/HDL Cholesterol Ratio
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2021.
- Background: PubMed 24900924Murphy 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.
- Background: PubMed 19171901Witte 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.
- Background: PubMed 23254518Akazawa 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.
- BackgroundSmith, 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
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandrine Thuret, PhD principal investigator
King's College London
Wendy L Hall, PhD principal investigator
King's College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent Energy Restriction, Chewing and Chewing + Intermittent Energy Restriction in people with Aging and Cognitive Decline, run by King's College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum Klotho concentration (time frame: Baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03457870, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2021.