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The Impact Of An Intermittent Energy Restricted Diet On Insulin Sensitivity In Men and Women With Central Obesity

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02679989
Acronym
Met-IER
Enrollment
42
Registered
2016-02-11
Start date
2016-02-29
Completion date
2016-07-31
Last updated
2019-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Abdominal

Keywords

Insulin sensitivity, Weight loss, Intermittent fasting, Sympathetic nervous system

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.

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.

Interventions

Dietary advice to follow 5:2 diet supported by physical activity advice and motivational group support sessions

Dietary advice to follow daily energy restricted diet supported by physical activity advice and motivational group support sessions

Sponsors

LighterLife (UK) Ltd
CollaboratorUNKNOWN
King's College London
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
35 Years to 75 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
RQUICKIday 29Marker of insulin sensitivity
Revised QUICKI (RQUICKI)BaselineMarker of insulin sensitivity

Secondary

MeasureTime frameDescription
Plasma insulin concentrationBaselineFasting
Plasma non-esterified fatty acid concentrationBaselineFasting
Plasma total cholesterol concentrationBaselineFasting
Plasma low density lipoprotein (LDL) cholesterol concentrationBaselineFasting
Plasma LDL cholesterol concentrationday 29Fasting
Plasma high density lipoprotein (HDL) cholesterol concentrationBaselineFasting
Plasma HDL cholesterol concentrationday 29Fasting
Plasma triglyceride concentrationBaselineFasting
Plasma total cholesterol:HDL cholesterol ratioBaselineFasting
Homeostasis model assessment estimated insulin resistance (HOMA-IR)BaselineFasting (calculated from insulin and glucose)
Plasma adiponectin concentrationBaselineFasting
Plasma leptin concentrationBaselineFasting
Plasma interleukin-6 concentrationBaselineFasting
Plasma beta-hydroxybutyrate concentrationBaselineFasting
Plasma norepinephrine concentrationBaselineFasting
Plasma soluble alpha-klotho concentrationBaselineFasting
Body weightBaseline
Body mass index (BMI)Baseline
BMIday 29
Waist circumferenceBaseline
Hip circumferenceBaseline
Percentage body fatBaseline
Percentage lean body massBaseline
Heart rate variability (resting)Baselinesupine
Heart rate variability (ambulatory)24 h recording at baseline
Heart rate variability (sleep-time)Baseline
Heart rate variability (during mental stress)Baseline
Ambulatory blood pressure 24 h24 h analysis at baseline
Ambulatory blood pressure daytimeDaytime analysis at baseline
Ambulatory blood pressure night-timeNight-time analysis at baseline
Digital volume pulse - stiffness index (SI)BaselineStiffness index
Digital volume pulse - SIday 29Stiffness index
Digital volume pulse - reflection index (RI)Baselinereflection index
Digital volume pulse - RIday 29reflection index
Power of food scaleBaselinequestionnaire
COPE (not an acronym)Baselinequestionnaire
COPEday 29questionnaire
Mnemonic Similarity TestBaseline
Plasma glucose concentrationBaselineFasting

Other

MeasureTime frame
Adverse eventsBaseline until endpoint: day 31 (+/-1 day)

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026