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The Impact Of An Intermittent Energy Restricted Diet On Insulin Sensitivity In Men and Women With Central Obesity (Met-IER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02679989
Recruitment Status : Completed
First Posted : February 11, 2016
Last Update Posted : September 17, 2019
Sponsor:
Collaborator:
LighterLife (UK) Ltd
Information provided by (Responsible Party):
King's College London

Brief 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 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.

Condition or disease Intervention/treatment Phase
Obesity, Abdominal Behavioral: Intermittent Energy Restriction Behavioral: Continuous Energy Restriction Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Study Start Date : February 2016
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arm Intervention/treatment
Experimental: Intermittent Energy Restriction
Weight loss intervention: Intermittent Energy Restriction
Behavioral: Intermittent Energy Restriction
Dietary advice to follow 5:2 diet supported by physical activity advice and motivational group support sessions

Active Comparator: Continuous Energy Restriction
Weight loss intervention: Continuous Energy Restriction
Behavioral: Continuous Energy Restriction
Dietary advice to follow daily energy restricted diet supported by physical activity advice and motivational group support sessions




Primary Outcome Measures :
  1. Revised QUICKI (RQUICKI) [ Time Frame: Baseline ]
    Marker of insulin sensitivity

  2. RQUICKI [ Time Frame: day 29 ]
    Marker of insulin sensitivity

  3. RQUICKI [ Time Frame: day 31 ]
    Marker of insulin sensitivity


Secondary Outcome Measures :
  1. Plasma glucose concentration [ Time Frame: Baseline ]
    Fasting

  2. Plasma glucose concentration [ Time Frame: day 29 ]
    Fasting

  3. Plasma glucose concentration [ Time Frame: day 31 ]
    Fasting

  4. Plasma insulin concentration [ Time Frame: Baseline ]
    Fasting

  5. Plasma insulin concentration [ Time Frame: day 29 ]
    Fasting

  6. Plasma insulin concentration [ Time Frame: day 31 ]
    Fasting

  7. Plasma non-esterified fatty acid concentration [ Time Frame: Baseline ]
    Fasting

  8. Plasma non-esterified fatty acid concentration [ Time Frame: day 29 ]
    Fasting

  9. Plasma non-esterified fatty acid concentration [ Time Frame: day 31 ]
    Fasting

  10. Plasma total cholesterol concentration [ Time Frame: Baseline ]
    Fasting

  11. Plasma total cholesterol concentration [ Time Frame: day 29 ]
    Fasting

  12. Plasma total cholesterol concentration [ Time Frame: day 31 ]
    Fasting

  13. Plasma low density lipoprotein (LDL) cholesterol concentration [ Time Frame: Baseline ]
    Fasting

  14. Plasma LDL cholesterol concentration [ Time Frame: day 29 ]
    Fasting

  15. Plasma LDL cholesterol concentration [ Time Frame: day 31 ]
    Fasting

  16. Plasma high density lipoprotein (HDL) cholesterol concentration [ Time Frame: Baseline ]
    Fasting

  17. Plasma HDL cholesterol concentration [ Time Frame: day 29 ]
    Fasting

  18. Plasma HDL cholesterol concentration [ Time Frame: day 31 ]
    Fasting

  19. Plasma triglyceride concentration [ Time Frame: Baseline ]
    Fasting

  20. Plasma triglyceride concentration [ Time Frame: day 29 ]
    Fasting

  21. Plasma triglyceride concentration [ Time Frame: day 31 ]
    Fasting

  22. Plasma total cholesterol:HDL cholesterol ratio [ Time Frame: Baseline ]
    Fasting

  23. Plasma total cholesterol:HDL cholesterol ratio [ Time Frame: day 29 ]
    Fasting

  24. Plasma total cholesterol:HDL cholesterol ratio [ Time Frame: day 31 ]
    Fasting

  25. Homeostasis model assessment estimated insulin resistance (HOMA-IR) [ Time Frame: Baseline ]
    Fasting (calculated from insulin and glucose)

  26. Homeostasis model assessment estimated insulin resistance (HOMA-IR) [ Time Frame: day 29 ]
    Fasting (calculated from insulin and glucose)

  27. Homeostasis model assessment estimated insulin resistance (HOMA-IR) [ Time Frame: day 31 ]
    Fasting (calculated from insulin and glucose)

  28. Plasma adiponectin concentration [ Time Frame: Baseline ]
    Fasting

  29. Plasma adiponectin concentration [ Time Frame: day 29 ]
    Fasting

  30. Plasma adiponectin concentration [ Time Frame: day 31 ]
    Fasting

  31. Plasma leptin concentration [ Time Frame: Baseline ]
    Fasting

  32. Plasma leptin concentration [ Time Frame: day 29 ]
    Fasting

  33. Plasma leptin concentration [ Time Frame: day 31 ]
    Fasting

  34. Plasma interleukin-6 concentration [ Time Frame: Baseline ]
    Fasting

  35. Plasma interleukin-6 concentration [ Time Frame: day 29 ]
    Fasting

  36. Plasma interleukin-6 concentration [ Time Frame: day 31 ]
    Fasting

  37. Plasma beta-hydroxybutyrate concentration [ Time Frame: Baseline ]
    Fasting

  38. Plasma beta-hydroxybutyrate concentration [ Time Frame: day 29 ]
    Fasting

  39. Plasma beta-hydroxybutyrate concentration [ Time Frame: day 31 ]
    Fasting

  40. Plasma norepinephrine concentration [ Time Frame: Baseline ]
    Fasting

  41. Plasma norepinephrine concentration [ Time Frame: day 29 ]
    Fasting

  42. Plasma norepinephrine concentration [ Time Frame: day 31 ]
    Fasting

  43. Plasma soluble alpha-klotho concentration [ Time Frame: Baseline ]
    Fasting

  44. Plasma soluble alpha-klotho concentration [ Time Frame: day 29 ]
    Fasting

  45. Plasma soluble alpha-klotho concentration [ Time Frame: day 31 ]
    Fasting

  46. Body weight [ Time Frame: Baseline ]
  47. Body weight [ Time Frame: day 29 ]
  48. Body weight [ Time Frame: day 31 ]
  49. Body mass index (BMI) [ Time Frame: Baseline ]
  50. BMI [ Time Frame: day 29 ]
  51. BMI [ Time Frame: day 31 ]
  52. Waist circumference [ Time Frame: Baseline ]
  53. Waist circumference [ Time Frame: day 29 ]
  54. Waist circumference [ Time Frame: day 31 ]
  55. Hip circumference [ Time Frame: Baseline ]
  56. Hip circumference [ Time Frame: day 29 ]
  57. Hip circumference [ Time Frame: day 31 ]
  58. Percentage body fat [ Time Frame: Baseline ]
  59. Percentage body fat [ Time Frame: day 29 ]
  60. Percentage body fat [ Time Frame: day 31 ]
  61. Percentage lean body mass [ Time Frame: Baseline ]
  62. Percentage lean body mass [ Time Frame: day 29 ]
  63. Percentage lean body mass [ Time Frame: day 31 ]
  64. Heart rate variability (resting) [ Time Frame: Baseline ]
    supine

  65. Heart rate variability (resting) [ Time Frame: day 29 ]
    supine

  66. Heart rate variability (resting) [ Time Frame: day 31 ]
    supine

  67. Heart rate variability (ambulatory) [ Time Frame: 24 h recording at baseline ]
  68. Heart rate variability (ambulatory) [ Time Frame: 24 h recording on day 29 ]
  69. Heart rate variability (ambulatory) [ Time Frame: 24 h recording on day 31 ]
  70. Heart rate variability (sleep-time) [ Time Frame: Baseline ]
  71. Heart rate variability (sleep-time) [ Time Frame: day 29 ]
  72. Heart rate variability (sleep-time) [ Time Frame: day 31 ]
  73. Heart rate variability (during mental stress) [ Time Frame: Baseline ]
  74. Heart rate variability (during mental stress) [ Time Frame: day 29 ]
  75. Heart rate variability (during mental stress) [ Time Frame: day 31 ]
  76. Ambulatory blood pressure 24 h [ Time Frame: 24 h analysis at baseline ]
  77. Ambulatory blood pressure daytime [ Time Frame: Daytime analysis at baseline ]
  78. Ambulatory blood pressure night-time [ Time Frame: Night-time analysis at baseline ]
  79. Ambulatory blood pressure 24 h [ Time Frame: 24 h analysis on day 29 ]
  80. Ambulatory blood pressure daytime [ Time Frame: daytime analysis on day 29 ]
  81. Ambulatory blood pressure night-time [ Time Frame: night-time analysis on day 29 ]
  82. Ambulatory blood pressure 24 h [ Time Frame: 24 h analysis on day 31 ]
    24 h

  83. Ambulatory blood pressure daytime [ Time Frame: Daytime analysis on day 31 ]
    day time

  84. Ambulatory blood pressure night-time [ Time Frame: Night-time analysis on day 31 ]
    night-time

  85. Digital volume pulse - stiffness index (SI) [ Time Frame: Baseline ]
    Stiffness index

  86. Digital volume pulse - SI [ Time Frame: day 29 ]
    Stiffness index

  87. Digital volume pulse - SI [ Time Frame: day 31 ]
    Stiffness index

  88. Digital volume pulse - reflection index (RI) [ Time Frame: Baseline ]
    reflection index

  89. Digital volume pulse - RI [ Time Frame: day 29 ]
    reflection index

  90. Digital volume pulse - RI [ Time Frame: day 31 ]
    reflection index

  91. Mnemonic Similarity Test [ Time Frame: Baseline ]
  92. Mnemonic Similarity Test [ Time Frame: day 29 ]
  93. Mnemonic Similarity Test [ Time Frame: day 31 ]
  94. Power of food scale [ Time Frame: Baseline ]
    questionnaire

  95. Power of food scale [ Time Frame: day 29 ]
    questionnaire

  96. Power of food scale [ Time Frame: day 31 ]
    questionnaire

  97. COPE (not an acronym) [ Time Frame: Baseline ]
    questionnaire

  98. COPE [ Time Frame: day 29 ]
    questionnaire

  99. COPE [ Time Frame: day 31 ]
    questionnaire


Other Outcome Measures:
  1. Adverse events [ Time Frame: Baseline until endpoint: day 31 (+/-1 day) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   35 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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;
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02679989


Locations
Layout table for location information
United Kingdom
Diabetes & Nutritional Sciences Division, King's College London, Franklin-Wilkins Buiding, 150 Stamford St.
London, England, United Kingdom, SE1 9NH
Sponsors and Collaborators
King's College London
LighterLife (UK) Ltd
Investigators
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Principal Investigator: Wendy Hall, PhD King's College London
Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: King's College London
ClinicalTrials.gov Identifier: NCT02679989    
Other Study ID Numbers: Met-IER2016
First Posted: February 11, 2016    Key Record Dates
Last Update Posted: September 17, 2019
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by King's College London:
Insulin sensitivity
Weight loss
Intermittent fasting
Sympathetic nervous system
Additional relevant MeSH terms:
Layout table for MeSH terms
Obesity
Insulin Resistance
Obesity, Abdominal
Hypersensitivity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Immune System Diseases
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases