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

NCT02679989 | Completed

• 1 other identifier: Met-IER2016
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity, Abdominal

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Revised QUICKI (RQUICKI)

  Marker of insulin sensitivity

  Baseline

• RQUICKI

  Marker of insulin sensitivity

  day 29

• RQUICKI

  Marker of insulin sensitivity

  day 31

Secondary Outcomes (99)

• Plasma glucose concentration

  Baseline

• Plasma glucose concentration

  day 29

• Plasma glucose concentration

  day 31

• Plasma insulin concentration

  Baseline

• Plasma insulin concentration

  day 29

Other Outcomes (1)

• Adverse events

  Baseline until endpoint: day 31 (+/-1 day)

Study Arms (2)

Intermittent Energy Restriction

EXPERIMENTAL

Weight loss intervention: Intermittent Energy Restriction

Behavioral: Intermittent Energy Restriction

Continuous Energy Restriction

ACTIVE COMPARATOR

Weight loss intervention: Continuous Energy Restriction

Behavioral: Continuous Energy Restriction

Interventions

Intermittent Energy Restriction BEHAVIORAL

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

Intermittent Energy Restriction

Continuous Energy Restriction BEHAVIORAL

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

Continuous Energy Restriction

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• King's College London: lead
• LighterLife (UK) Ltd: collaborator

Study Sites (1)

Diabetes & Nutritional Sciences Division, King's College London, Franklin-Wilkins Buiding, 150 Stamford St.

London, England, SE1 9NH, United Kingdom

Location

Related Publications (5)

• 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.

  PMID: 23591120 BACKGROUND

• 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.

  PMID: 20921964 BACKGROUND

• 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.

  PMID: 33512717 DERIVED

• 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.

  PMID: 32121111 DERIVED

• 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.

  PMID: 31409509 DERIVED

Related Links

• Primary publication

MeSH Terms

Conditions

Obesity, Abdominal; Insulin Resistance; Weight Loss; Intermittent Fasting

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Body Weight Changes; Fasting; Feeding Behavior; Behavior

Study Officials

• Wendy Hall, PhD

  King's College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2016
• First Posted: February 11, 2016
• Study Start: February 1, 2016
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: September 17, 2019

Record last verified: 2016-07

Locations

GB (1)