Obesity, AbdominalMet-IERNCT02679989
The Impact Of An Intermittent Energy Restricted Diet On Insulin Sensitivity In Men and Women With Central Obesity
A study testing Intermittent Energy Restriction and Continuous Energy Restriction in people with Obesity, Abdominal, run by King's College London at 1 site in United Kingdom.
Trial summary
An intermittent energy restricted (IER) diet may modify cardio-metabolic disease risk factors compared to an energy-matched continuous energy restricted (CER) diet. A randomised controlled parallel design trial will determine the impact of a short-term IER diet (2 consecutive days of very low calorie diet (VLCD), 5… Read more about this study
- Who is it for?
- Ages 35 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Abdominal
- What is being tested?
- Intermittent Energy Restriction and Continuous Energy Restriction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2016to Jul 2016
- 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 35 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged >35-75 years
- Waist circumference above cut-off for high risk of cardio-metabolic disease of >102 cm in men with a Europid, Black African and Caribbean, and other ethnic background and >88 cm in women with a Europid, Black African and Caribbean, and other ethnic background (WHO, 2008), and ≥90 cm in men and ≥80 cm in women with an Asian background (South Asian and East Asian) (Misra et al., 2009).
- REFERENCES Misra A, Chowbey P, Makkar BM, Vikram NK, Wasir JS, Chadha D, et al. (2009). Consensus statement for diagnosis of obesity, abdominal obesity and the metabolic syndrome for Asian Indians and recommendations for physical activity, medical and surgical management. The Journal of the Association of Physicians of India 57: 163170.
- WHO (2008). Waist circumference and waist-hip ratio: report of a WHO expert consultation. Geneva, 8-11 December 2008.
Who cannot join
- Kidney or cardiovascular disease, cancer, diabetes, gastrointestinal or chronic liver disease;
- previous bariatric surgery or other major surgery (e.g. organ transplantation);
- unable to provide written informed consent;
- have significant psychiatric disorder (e.g. schizophrenia, anxiety, panic disorder, attention deficit disorder, post-traumatic stress disorder, obsessive compulsive disorder) or uncontrolled depression;
- participated in a weight management drug trial in the previous 3 months;
- have binge eating behaviour;
Show all 11Show fewer
- have uncontrolled epilepsy;
- alcohol or substance abuse;
- currently pregnant, lactating, or planning pregnancy within the study period;
- are using medication clinically deemed to affect metabolic rate and weight (e.g. beta blockers, corticosteroids, diuretics, etc);
- lactose intolerant.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Diabetes & Nutritional Sciences Division, King's College London, Franklin-Wilkins Buiding, 150 Stamford St.
London, England, SE1 9NH
About this study
Official title: A Randomised Controlled Trial Assessing The Impact Of An Intermittent Energy Restricted Diet On Weight Loss, Insulin Sensitivity and Heart Rate Variability In Men and Women With Central Obesity
An intermittent energy restricted (IER) diet may modify cardio-metabolic disease risk factors compared to an energy-matched continuous energy restricted (CER) diet. A randomised controlled parallel design trial will determine the impact of a short-term IER diet (2 consecutive days of very low calorie diet (VLCD), 5 days moderate energy restriction each week for a 4 week period), compared to a CER diet, on insulin sensitivity in healthy (disease-free) subjects with central obesity.
Read the detailed description
Prediabetes rates in England have showed a marked increase, more than tripling between 2003 and 2011. It is characterised by an impaired fasting glucose or impaired glucose tolerance that increases the risk of progression to type 2 diabetes (T2D). It has been estimated that approximately 90% of T2D is attributed to excess weight. Central obesity is a primary driver of increased cardiometabolic risk due to its lipotoxicity effects, promoting a proinflammatory state that facilitates insulin resistance and beta cell dysfunction. A high waist circumference measurement, indicative of central obesity, is associated with increased risk of cardiovascular diseases and T2D, and is a stronger predictor of T2D than BMI. BMI has limitations as an indicator of adiposity since it doesn't distinguish lean from fat mass, and does not indicate body fat distribution. Conventionally, continuous energy restriction (CER) diets have been used for weight loss, which consist of a constant daily energy deficit relative to total energy expenditure. The impact on weight loss and health of an intermittent energy restriction (IER) approach has only rarely been investigated (although the "5:2 diet" has been popularised in lifestyle books aimed at the general public). An IER diet consists of a predefined period of time severely restricting energy intake, alternated with a period of greater energy intake. This approach was shown to confer metabolic benefits in overweight and obese women at risk of breast cancer with baseline BMI of 2445 (Harvie et al., 2013; Harvie et al., 2011).
Rationale: An IER diet using meal replacements (VLCD foodpacks used as total dietary replacements for 2 consecutive days each week, and a food-based energy-restricted diet for the other 5 days of the week) may modify cardio-metabolic disease risk factors compared to an energy-matched CER diet.
Research question: In centrally obese subjects, assessed by a high waist circumference measurement, does adherence to an IER diet have enhanced cardio-metabolic benefits compared to a CER diet? Hypothesis: Increases in insulin sensitivity following a 4 week dietary intervention with an IER weight loss programme will be greater compared to a standard CER programme.
Objectives:
- A randomised controlled parallel design trial will determine the impact of a short-term IER diet compared to a CER diet on primary outcome variables (insulin sensitivity) in healthy subjects with a high waist circumference.
- To assess the impact of an IER diet on secondary outcome variables, including body composition, heart rate variability (HRV, a measure of cardiac autonomic function, including parasympathetic and sympathetic activity), blood pressure, vascular function, other markers of insulin resistance, inflammation/adipokines, plasma lipid profile, plasma norepinephrine, ketosis, the gut microbiome and cognitive function in healthy subjects with a high waist circumference.
- Conditions
- Obesity, Abdominal
- Being tested
- Intermittent Energy Restriction, Continuous Energy Restriction
- Keywords
- Insulin sensitivity, Weight loss, Intermittent fasting, Sympathetic nervous system
- Medical subject headings
- Obesity, Abdominal, Insulin Resistance, Weight Loss, 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 5:2 diet supported by physical activity advice and motivational group support sessions
Continuous Energy RestrictionBehavioural
Dietary advice to follow daily energy restricted diet supported by physical activity advice and motivational group support sessions
| Study group | Role | What they receive |
|---|---|---|
| Intermittent Energy Restriction | Experimental | Weight loss intervention: Intermittent Energy Restriction Receives: Behavioral: Intermittent Energy Restriction |
| Continuous Energy Restriction | Active comparator | Weight loss intervention: Continuous Energy Restriction Receives: Behavioral: Continuous Energy Restriction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Revised QUICKI (RQUICKI)
Marker of insulin sensitivity
Measured: Baseline
RQUICKI
Marker of insulin sensitivity
Measured: day 29
RQUICKI
Marker of insulin sensitivity
Measured: day 31
Secondary outcomes (99)
Plasma glucose concentration
Fasting
Measured: Baseline
Plasma glucose concentration
Fasting
Measured: day 29
Plasma glucose concentration
Fasting
Measured: day 31
Plasma insulin concentration
Fasting
Measured: Baseline
Plasma insulin concentration
Fasting
Measured: day 29
Plasma insulin concentration
Fasting
Measured: day 31
Plasma non-esterified fatty acid concentration
Fasting
Measured: Baseline
Plasma non-esterified fatty acid concentration
Fasting
Measured: day 29
Plasma non-esterified fatty acid concentration
Fasting
Measured: day 31
Plasma total cholesterol concentration
Fasting
Measured: Baseline
Plasma total cholesterol concentration
Fasting
Measured: day 29
Plasma total cholesterol concentration
Fasting
Measured: day 31
Plasma low density lipoprotein (LDL) cholesterol concentration
Fasting
Measured: Baseline
Plasma LDL cholesterol concentration
Fasting
Measured: day 29
Plasma LDL cholesterol concentration
Fasting
Measured: day 31
Plasma high density lipoprotein (HDL) cholesterol concentration
Fasting
Measured: Baseline
Plasma HDL cholesterol concentration
Fasting
Measured: day 29
Plasma HDL cholesterol concentration
Fasting
Measured: day 31
Plasma triglyceride concentration
Fasting
Measured: Baseline
Plasma triglyceride concentration
Fasting
Measured: day 29
Plasma triglyceride concentration
Fasting
Measured: day 31
Plasma total cholesterol:HDL cholesterol ratio
Fasting
Measured: Baseline
Plasma total cholesterol:HDL cholesterol ratio
Fasting
Measured: day 29
Plasma total cholesterol:HDL cholesterol ratio
Fasting
Measured: day 31
Homeostasis model assessment estimated insulin resistance (HOMA-IR)
Fasting (calculated from insulin and glucose)
Measured: Baseline
Homeostasis model assessment estimated insulin resistance (HOMA-IR)
Fasting (calculated from insulin and glucose)
Measured: day 29
Homeostasis model assessment estimated insulin resistance (HOMA-IR)
Fasting (calculated from insulin and glucose)
Measured: day 31
Plasma adiponectin concentration
Fasting
Measured: Baseline
Plasma adiponectin concentration
Fasting
Measured: day 29
Plasma adiponectin concentration
Fasting
Measured: day 31
Plasma leptin concentration
Fasting
Measured: Baseline
Plasma leptin concentration
Fasting
Measured: day 29
Plasma leptin concentration
Fasting
Measured: day 31
Plasma interleukin-6 concentration
Fasting
Measured: Baseline
Plasma interleukin-6 concentration
Fasting
Measured: day 29
Plasma interleukin-6 concentration
Fasting
Measured: day 31
Plasma beta-hydroxybutyrate concentration
Fasting
Measured: Baseline
Plasma beta-hydroxybutyrate concentration
Fasting
Measured: day 29
Plasma beta-hydroxybutyrate concentration
Fasting
Measured: day 31
Plasma norepinephrine concentration
Fasting
Measured: Baseline
Plasma norepinephrine concentration
Fasting
Measured: day 29
Plasma norepinephrine concentration
Fasting
Measured: day 31
Plasma soluble alpha-klotho concentration
Fasting
Measured: Baseline
Plasma soluble alpha-klotho concentration
Fasting
Measured: day 29
Plasma soluble alpha-klotho concentration
Fasting
Measured: day 31
Body weight
Measured: Baseline
Body weight
Measured: day 29
Body weight
Measured: day 31
Body mass index (BMI)
Measured: Baseline
BMI
Measured: day 29
BMI
Measured: day 31
Waist circumference
Measured: Baseline
Waist circumference
Measured: day 29
Waist circumference
Measured: day 31
Hip circumference
Measured: Baseline
Hip circumference
Measured: day 29
Hip circumference
Measured: day 31
Percentage body fat
Measured: Baseline
Percentage body fat
Measured: day 29
Percentage body fat
Measured: day 31
Percentage lean body mass
Measured: Baseline
Percentage lean body mass
Measured: day 29
Percentage lean body mass
Measured: day 31
Heart rate variability (resting)
supine
Measured: Baseline
Heart rate variability (resting)
supine
Measured: day 29
Heart rate variability (resting)
supine
Measured: day 31
Heart rate variability (ambulatory)
Measured: 24 h recording at baseline
Heart rate variability (ambulatory)
Measured: 24 h recording on day 29
Heart rate variability (ambulatory)
Measured: 24 h recording on day 31
Heart rate variability (sleep-time)
Measured: Baseline
Heart rate variability (sleep-time)
Measured: day 29
Heart rate variability (sleep-time)
Measured: day 31
Heart rate variability (during mental stress)
Measured: Baseline
Heart rate variability (during mental stress)
Measured: day 29
Heart rate variability (during mental stress)
Measured: day 31
Ambulatory blood pressure 24 h
Measured: 24 h analysis at baseline
Ambulatory blood pressure daytime
Measured: Daytime analysis at baseline
Ambulatory blood pressure night-time
Measured: Night-time analysis at baseline
Ambulatory blood pressure 24 h
Measured: 24 h analysis on day 29
Ambulatory blood pressure daytime
Measured: daytime analysis on day 29
Ambulatory blood pressure night-time
Measured: night-time analysis on day 29
Ambulatory blood pressure 24 h
24 h
Measured: 24 h analysis on day 31
Ambulatory blood pressure daytime
day time
Measured: Daytime analysis on day 31
Ambulatory blood pressure night-time
night-time
Measured: Night-time analysis on day 31
Digital volume pulse - stiffness index (SI)
Stiffness index
Measured: Baseline
Digital volume pulse - SI
Stiffness index
Measured: day 29
Digital volume pulse - SI
Stiffness index
Measured: day 31
Digital volume pulse - reflection index (RI)
reflection index
Measured: Baseline
Digital volume pulse - RI
reflection index
Measured: day 29
Digital volume pulse - RI
reflection index
Measured: day 31
Mnemonic Similarity Test
Measured: Baseline
Mnemonic Similarity Test
Measured: day 29
Mnemonic Similarity Test
Measured: day 31
Power of food scale
questionnaire
Measured: Baseline
Power of food scale
questionnaire
Measured: day 29
Power of food scale
questionnaire
Measured: day 31
COPE (not an acronym)
questionnaire
Measured: Baseline
COPE
questionnaire
Measured: day 29
COPE
questionnaire
Measured: day 31
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Obesity, AbdominalStudies 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
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- LighterLife (UK) Ltd
- Responsible party
- Sponsor
- Investigators
- Wendy Hall, PhD, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02679989
- Sponsor's protocol ID
- Met-IER2016
- Acronym
- Met-IER
- Status last verified
- Jul 2016
- First submitted
- 22 Jan 2016
- Last updated
- 17 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Harvie M, Wright C, Pegington M, McMullan D, Mitchell E, Martin B, Cutler RG, Evans G, Whiteside S, Maudsley S, Camandola S, Wang R, Carlson OD, Egan JM, Mattson MP, Howell A. The effect of intermittent energy and carbohydrate restriction v. daily energy restriction on weight loss and metabolic disease risk markers in overweight women. Br J Nutr. 2013 Oct;110(8):1534-47. doi: 10.1017/S0007114513000792. Epub 2013 Apr 16.
PubMed 23591120Harvie MN, Pegington M, Mattson MP, Frystyk J, Dillon B, Evans G, Cuzick J, Jebb SA, Martin B, Cutler RG, Son TG, Maudsley S, Carlson OD, Egan JM, Flyvbjerg A, Howell A. The effects of intermittent or continuous energy restriction on weight loss and metabolic disease risk markers: a randomized trial in young overweight women. Int J Obes (Lond). 2011 May;35(5):714-27. doi: 10.1038/ijo.2010.171. Epub 2010 Oct 5.
PubMed 20921964Allaf M, Elghazaly H, Mohamed OG, Fareen MFK, Zaman S, Salmasi AM, Tsilidis K, Dehghan A. Intermittent fasting for the prevention of cardiovascular disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013496. doi: 10.1002/14651858.CD013496.pub2.
PubMed 33512717Kim C, Pinto AM, Bordoli C, Buckner LP, Kaplan PC, Del Arenal IM, Jeffcock EJ, Hall WL, Thuret S. Energy Restriction Enhances Adult Hippocampal Neurogenesis-Associated Memory after Four Weeks in an Adult Human Population with Central Obesity; a Randomized Controlled Trial. Nutrients. 2020 Feb 28;12(3):638. doi: 10.3390/nu12030638.
PubMed 32121111Pinto AM, Bordoli C, Buckner LP, Kim C, Kaplan PC, Del Arenal IM, Jeffcock EJ, Hall WL. Intermittent energy restriction is comparable to continuous energy restriction for cardiometabolic health in adults with central obesity: A randomized controlled trial; the Met-IER study. Clin Nutr. 2020 Jun;39(6):1753-1763. doi: 10.1016/j.clnu.2019.07.014. Epub 2019 Jul 30.
PubMed 31409509
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial Assessing The Impact Of An Intermittent Energy Restricted Diet On Weight Loss, Insulin Sensitivity and Heart Rate Variability In Men and Women With Central Obesity
- ClinicalTrials.gov ID
- NCT02679989
- Acronym / sponsor ID
- Met-IER / Met-IER2016
- Conditions
- Obesity, Abdominal
- Keywords
- Insulin sensitivity, Weight loss, Intermittent fasting, Sympathetic nervous system
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- LighterLife (UK) Ltd
- Study start
- Feb 2016
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 11 Feb 2016 (estimated)
- 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.
An intermittent energy restricted (IER) diet may modify cardio-metabolic disease risk factors compared to an energy-matched continuous energy restricted (CER) diet. A randomised controlled parallel design trial will determine the impact of a short-term IER diet (2 consecutive days of very low calorie diet (VLCD), 5 days moderate energy restriction each week for a 4 week period), compared to a CER diet, on insulin sensitivity in healthy (disease-free) subjects with central obesity.
Detailed description
Prediabetes rates in England have showed a marked increase, more than tripling between 2003 and 2011. It is characterised by an impaired fasting glucose or impaired glucose tolerance that increases the risk of progression to type 2 diabetes (T2D). It has been estimated that approximately 90% of T2D is attributed to excess weight. Central obesity is a primary driver of increased cardiometabolic risk due to its lipotoxicity effects, promoting a proinflammatory state that facilitates insulin resistance and beta cell dysfunction. A high waist circumference measurement, indicative of central obesity, is associated with increased risk of cardiovascular diseases and T2D, and is a stronger predictor of T2D than BMI. BMI has limitations as an indicator of adiposity since it doesn't distinguish lean from fat mass, and does not indicate body fat distribution. Conventionally, continuous energy restriction (CER) diets have been used for weight loss, which consist of a constant daily energy deficit relative to total energy expenditure. The impact on weight loss and health of an intermittent energy restriction (IER) approach has only rarely been investigated (although the "5:2 diet" has been popularised in lifestyle books aimed at the general public). An IER diet consists of a predefined period of time severely restricting energy intake, alternated with a period of greater energy intake. This approach was shown to confer metabolic benefits in overweight and obese women at risk of breast cancer with baseline BMI of 2445 (Harvie et al., 2013; Harvie et al., 2011).
Rationale: An IER diet using meal replacements (VLCD foodpacks used as total dietary replacements for 2 consecutive days each week, and a food-based energy-restricted diet for the other 5 days of the week) may modify cardio-metabolic disease risk factors compared to an energy-matched CER diet.
Research question: In centrally obese subjects, assessed by a high waist circumference measurement, does adherence to an IER diet have enhanced cardio-metabolic benefits compared to a CER diet? Hypothesis: Increases in insulin sensitivity following a 4 week dietary intervention with an IER weight loss programme will be greater compared to a standard CER programme.
Objectives:
- A randomised controlled parallel design trial will determine the impact of a short-term IER diet compared to a CER diet on primary outcome variables (insulin sensitivity) in healthy subjects with a high waist circumference.
- To assess the impact of an IER diet on secondary outcome variables, including body composition, heart rate variability (HRV, a measure of cardiac autonomic function, including parasympathetic and sympathetic activity), blood pressure, vascular function, other markers of insulin resistance, inflammation/adipokines, plasma lipid profile, plasma norepinephrine, ketosis, the gut microbiome and cognitive function in healthy subjects with a high waist circumference.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intermittent Energy Restriction | Experimental | Behavioral: Intermittent Energy RestrictionWeight loss intervention: Intermittent Energy Restriction |
| Continuous Energy Restriction | Active comparator | Behavioral: Continuous Energy RestrictionWeight loss intervention: Continuous Energy Restriction |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged >35-75 years
- Waist circumference above cut-off for high risk of cardio-metabolic disease of >102 cm in men with a Europid, Black African and Caribbean, and other ethnic background and >88 cm in women with a Europid, Black African and Caribbean, and other ethnic background (WHO, 2008), and ≥90 cm in men and ≥80 cm in women with an Asian background (South Asian and East Asian) (Misra et al., 2009).
- REFERENCES Misra A, Chowbey P, Makkar BM, Vikram NK, Wasir JS, Chadha D, et al. (2009). Consensus statement for diagnosis of obesity, abdominal obesity and the metabolic syndrome for Asian Indians and recommendations for physical activity, medical and surgical management. The Journal of the Association of Physicians of India 57: 163170.
- WHO (2008). Waist circumference and waist-hip ratio: report of a WHO expert consultation. Geneva, 8-11 December 2008.
Key exclusion criteria (11 listed)
- Kidney or cardiovascular disease, cancer, diabetes, gastrointestinal or chronic liver disease;
- previous bariatric surgery or other major surgery (e.g. organ transplantation);
- unable to provide written informed consent;
- have significant psychiatric disorder (e.g. schizophrenia, anxiety, panic disorder, attention deficit disorder, post-traumatic stress disorder, obsessive compulsive disorder) or uncontrolled depression;
- participated in a weight management drug trial in the previous 3 months;
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 5:2 diet supported by physical activity advice and motivational group support sessions | Behavioural | Intermittent Energy Restriction |
| Continuous Energy RestrictionDietary advice to follow daily energy restricted diet supported by physical activity advice and motivational group support sessions | Behavioural | Continuous Energy Restriction |
Primary outcome
Revised QUICKI (RQUICKI)
Time frame: Baseline
Marker of insulin sensitivity
RQUICKI
Time frame: day 29
Marker of insulin sensitivity
RQUICKI
Time frame: day 31
Marker of insulin sensitivity
99 secondary outcomes
Plasma glucose concentration
Time frame: Baseline
Plasma glucose concentration
Time frame: day 29
Plasma glucose concentration
Time frame: day 31
Plasma insulin concentration
Time frame: Baseline
Plasma insulin concentration
Time frame: day 29
Plasma insulin concentration
Time frame: day 31
Plasma non-esterified fatty acid concentration
Time frame: Baseline
Plasma non-esterified fatty acid concentration
Time frame: day 29
Plasma non-esterified fatty acid concentration
Time frame: day 31
Plasma total cholesterol concentration
Time frame: Baseline
Plasma total cholesterol concentration
Time frame: day 29
Plasma total cholesterol concentration
Time frame: day 31
Plasma low density lipoprotein (LDL) cholesterol concentration
Time frame: Baseline
Plasma LDL cholesterol concentration
Time frame: day 29
Plasma LDL cholesterol concentration
Time frame: day 31
Plasma high density lipoprotein (HDL) cholesterol concentration
Time frame: Baseline
Plasma HDL cholesterol concentration
Time frame: day 29
Plasma HDL cholesterol concentration
Time frame: day 31
Plasma triglyceride concentration
Time frame: Baseline
Plasma triglyceride concentration
Time frame: day 29
Plasma triglyceride concentration
Time frame: day 31
Plasma total cholesterol:HDL cholesterol ratio
Time frame: Baseline
Plasma total cholesterol:HDL cholesterol ratio
Time frame: day 29
Plasma total cholesterol:HDL cholesterol ratio
Time frame: day 31
Homeostasis model assessment estimated insulin resistance (HOMA-IR)
Time frame: Baseline
Homeostasis model assessment estimated insulin resistance (HOMA-IR)
Time frame: day 29
Homeostasis model assessment estimated insulin resistance (HOMA-IR)
Time frame: day 31
Plasma adiponectin concentration
Time frame: Baseline
Plasma adiponectin concentration
Time frame: day 29
Plasma adiponectin concentration
Time frame: day 31
Plasma leptin concentration
Time frame: Baseline
Plasma leptin concentration
Time frame: day 29
Plasma leptin concentration
Time frame: day 31
Plasma interleukin-6 concentration
Time frame: Baseline
Plasma interleukin-6 concentration
Time frame: day 29
Plasma interleukin-6 concentration
Time frame: day 31
Plasma beta-hydroxybutyrate concentration
Time frame: Baseline
Plasma beta-hydroxybutyrate concentration
Time frame: day 29
Plasma beta-hydroxybutyrate concentration
Time frame: day 31
Plasma norepinephrine concentration
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 17 Sep 2019.
- Background: PubMed 23591120Harvie M, Wright C, Pegington M, McMullan D, Mitchell E, Martin B, Cutler RG, Evans G, Whiteside S, Maudsley S, Camandola S, Wang R, Carlson OD, Egan JM, Mattson MP, Howell A. The effect of intermittent energy and carbohydrate restriction v. daily energy restriction on weight loss and metabolic disease risk markers in overweight women. Br J Nutr. 2013 Oct;110(8):1534-47. doi: 10.1017/S0007114513000792. Epub 2013 Apr 16.
- Background: PubMed 20921964Harvie MN, Pegington M, Mattson MP, Frystyk J, Dillon B, Evans G, Cuzick J, Jebb SA, Martin B, Cutler RG, Son TG, Maudsley S, Carlson OD, Egan JM, Flyvbjerg A, Howell A. The effects of intermittent or continuous energy restriction on weight loss and metabolic disease risk markers: a randomized trial in young overweight women. Int J Obes (Lond). 2011 May;35(5):714-27. doi: 10.1038/ijo.2010.171. Epub 2010 Oct 5.
- Derived from this study: PubMed 33512717Allaf M, Elghazaly H, Mohamed OG, Fareen MFK, Zaman S, Salmasi AM, Tsilidis K, Dehghan A. Intermittent fasting for the prevention of cardiovascular disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013496. doi: 10.1002/14651858.CD013496.pub2.
- Derived from this study: PubMed 32121111Kim C, Pinto AM, Bordoli C, Buckner LP, Kaplan PC, Del Arenal IM, Jeffcock EJ, Hall WL, Thuret S. Energy Restriction Enhances Adult Hippocampal Neurogenesis-Associated Memory after Four Weeks in an Adult Human Population with Central Obesity; a Randomized Controlled Trial. Nutrients. 2020 Feb 28;12(3):638. doi: 10.3390/nu12030638.
- Derived from this study: PubMed 31409509Pinto AM, Bordoli C, Buckner LP, Kim C, Kaplan PC, Del Arenal IM, Jeffcock EJ, Hall WL. Intermittent energy restriction is comparable to continuous energy restriction for cardiometabolic health in adults with central obesity: A randomized controlled trial; the Met-IER study. Clin Nutr. 2020 Jun;39(6):1753-1763. doi: 10.1016/j.clnu.2019.07.014. Epub 2019 Jul 30.
- Primary publicationLink provided by the sponsor.
- 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.
Wendy 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 and Continuous Energy Restriction in people with Obesity, Abdominal, 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 4 inclusion and 11 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 17 Sep 2019. 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?
Revised QUICKI (RQUICKI) (time frame: Baseline). The study lists 3 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 NCT02679989, which also lists 5 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 17 Sep 2019.