AzTrials
AzTrials

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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
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

Other trials in United Kingdom

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:

  1. 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.
  2. 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.
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 groups in NCT02679989
Study groupRoleWhat they receive
Intermittent Energy RestrictionExperimentalWeight loss intervention: Intermittent Energy Restriction
Receives: Behavioral: Intermittent Energy Restriction
Continuous Energy RestrictionActive comparatorWeight 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.

  1. Revised QUICKI (RQUICKI)

    Marker of insulin sensitivity

    Measured: Baseline

  2. RQUICKI

    Marker of insulin sensitivity

    Measured: day 29

  3. RQUICKI

    Marker of insulin sensitivity

    Measured: day 31

Secondary outcomes (99)

  1. Plasma glucose concentration

    Fasting

    Measured: Baseline

  2. Plasma glucose concentration

    Fasting

    Measured: day 29

  3. Plasma glucose concentration

    Fasting

    Measured: day 31

  4. Plasma insulin concentration

    Fasting

    Measured: Baseline

  5. Plasma insulin concentration

    Fasting

    Measured: day 29

  6. Plasma insulin concentration

    Fasting

    Measured: day 31

  7. Plasma non-esterified fatty acid concentration

    Fasting

    Measured: Baseline

  8. Plasma non-esterified fatty acid concentration

    Fasting

    Measured: day 29

  9. Plasma non-esterified fatty acid concentration

    Fasting

    Measured: day 31

  10. Plasma total cholesterol concentration

    Fasting

    Measured: Baseline

  11. Plasma total cholesterol concentration

    Fasting

    Measured: day 29

  12. Plasma total cholesterol concentration

    Fasting

    Measured: day 31

  13. Plasma low density lipoprotein (LDL) cholesterol concentration

    Fasting

    Measured: Baseline

  14. Plasma LDL cholesterol concentration

    Fasting

    Measured: day 29

  15. Plasma LDL cholesterol concentration

    Fasting

    Measured: day 31

  16. Plasma high density lipoprotein (HDL) cholesterol concentration

    Fasting

    Measured: Baseline

  17. Plasma HDL cholesterol concentration

    Fasting

    Measured: day 29

  18. Plasma HDL cholesterol concentration

    Fasting

    Measured: day 31

  19. Plasma triglyceride concentration

    Fasting

    Measured: Baseline

  20. Plasma triglyceride concentration

    Fasting

    Measured: day 29

  21. Plasma triglyceride concentration

    Fasting

    Measured: day 31

  22. Plasma total cholesterol:HDL cholesterol ratio

    Fasting

    Measured: Baseline

  23. Plasma total cholesterol:HDL cholesterol ratio

    Fasting

    Measured: day 29

  24. Plasma total cholesterol:HDL cholesterol ratio

    Fasting

    Measured: day 31

  25. Homeostasis model assessment estimated insulin resistance (HOMA-IR)

    Fasting (calculated from insulin and glucose)

    Measured: Baseline

  26. Homeostasis model assessment estimated insulin resistance (HOMA-IR)

    Fasting (calculated from insulin and glucose)

    Measured: day 29

  27. Homeostasis model assessment estimated insulin resistance (HOMA-IR)

    Fasting (calculated from insulin and glucose)

    Measured: day 31

  28. Plasma adiponectin concentration

    Fasting

    Measured: Baseline

  29. Plasma adiponectin concentration

    Fasting

    Measured: day 29

  30. Plasma adiponectin concentration

    Fasting

    Measured: day 31

  31. Plasma leptin concentration

    Fasting

    Measured: Baseline

  32. Plasma leptin concentration

    Fasting

    Measured: day 29

  33. Plasma leptin concentration

    Fasting

    Measured: day 31

  34. Plasma interleukin-6 concentration

    Fasting

    Measured: Baseline

  35. Plasma interleukin-6 concentration

    Fasting

    Measured: day 29

  36. Plasma interleukin-6 concentration

    Fasting

    Measured: day 31

  37. Plasma beta-hydroxybutyrate concentration

    Fasting

    Measured: Baseline

  38. Plasma beta-hydroxybutyrate concentration

    Fasting

    Measured: day 29

  39. Plasma beta-hydroxybutyrate concentration

    Fasting

    Measured: day 31

  40. Plasma norepinephrine concentration

    Fasting

    Measured: Baseline

  41. Plasma norepinephrine concentration

    Fasting

    Measured: day 29

  42. Plasma norepinephrine concentration

    Fasting

    Measured: day 31

  43. Plasma soluble alpha-klotho concentration

    Fasting

    Measured: Baseline

  44. Plasma soluble alpha-klotho concentration

    Fasting

    Measured: day 29

  45. Plasma soluble alpha-klotho concentration

    Fasting

    Measured: day 31

  46. Body weight

    Measured: Baseline

  47. Body weight

    Measured: day 29

  48. Body weight

    Measured: day 31

  49. Body mass index (BMI)

    Measured: Baseline

  50. BMI

    Measured: day 29

  51. BMI

    Measured: day 31

  52. Waist circumference

    Measured: Baseline

  53. Waist circumference

    Measured: day 29

  54. Waist circumference

    Measured: day 31

  55. Hip circumference

    Measured: Baseline

  56. Hip circumference

    Measured: day 29

  57. Hip circumference

    Measured: day 31

  58. Percentage body fat

    Measured: Baseline

  59. Percentage body fat

    Measured: day 29

  60. Percentage body fat

    Measured: day 31

  61. Percentage lean body mass

    Measured: Baseline

  62. Percentage lean body mass

    Measured: day 29

  63. Percentage lean body mass

    Measured: day 31

  64. Heart rate variability (resting)

    supine

    Measured: Baseline

  65. Heart rate variability (resting)

    supine

    Measured: day 29

  66. Heart rate variability (resting)

    supine

    Measured: day 31

  67. Heart rate variability (ambulatory)

    Measured: 24 h recording at baseline

  68. Heart rate variability (ambulatory)

    Measured: 24 h recording on day 29

  69. Heart rate variability (ambulatory)

    Measured: 24 h recording on day 31

  70. Heart rate variability (sleep-time)

    Measured: Baseline

  71. Heart rate variability (sleep-time)

    Measured: day 29

  72. Heart rate variability (sleep-time)

    Measured: day 31

  73. Heart rate variability (during mental stress)

    Measured: Baseline

  74. Heart rate variability (during mental stress)

    Measured: day 29

  75. Heart rate variability (during mental stress)

    Measured: day 31

  76. Ambulatory blood pressure 24 h

    Measured: 24 h analysis at baseline

  77. Ambulatory blood pressure daytime

    Measured: Daytime analysis at baseline

  78. Ambulatory blood pressure night-time

    Measured: Night-time analysis at baseline

  79. Ambulatory blood pressure 24 h

    Measured: 24 h analysis on day 29

  80. Ambulatory blood pressure daytime

    Measured: daytime analysis on day 29

  81. Ambulatory blood pressure night-time

    Measured: night-time analysis on day 29

  82. Ambulatory blood pressure 24 h

    24 h

    Measured: 24 h analysis on day 31

  83. Ambulatory blood pressure daytime

    day time

    Measured: Daytime analysis on day 31

  84. Ambulatory blood pressure night-time

    night-time

    Measured: Night-time analysis on day 31

  85. Digital volume pulse - stiffness index (SI)

    Stiffness index

    Measured: Baseline

  86. Digital volume pulse - SI

    Stiffness index

    Measured: day 29

  87. Digital volume pulse - SI

    Stiffness index

    Measured: day 31

  88. Digital volume pulse - reflection index (RI)

    reflection index

    Measured: Baseline

  89. Digital volume pulse - RI

    reflection index

    Measured: day 29

  90. Digital volume pulse - RI

    reflection index

    Measured: day 31

  91. Mnemonic Similarity Test

    Measured: Baseline

  92. Mnemonic Similarity Test

    Measured: day 29

  93. Mnemonic Similarity Test

    Measured: day 31

  94. Power of food scale

    questionnaire

    Measured: Baseline

  95. Power of food scale

    questionnaire

    Measured: day 29

  96. Power of food scale

    questionnaire

    Measured: day 31

  97. COPE (not an acronym)

    questionnaire

    Measured: Baseline

  98. COPE

    questionnaire

    Measured: day 29

  99. 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.

  1. First posted11 Feb 2016 (estimated)
  2. Study startFeb 2016
  3. Primary completionJul 2016
  4. Study completionJul 2016

Resources

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)
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 23591120

  • Harvie 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 20921964

  • Allaf 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 33512717

  • Kim 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 32121111

  • Pinto 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

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.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in