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Daily vs Intermittent Restriction of Energy: Controlled Trial to Reduce Diabetes Risk (DIRECT)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03689608
Recruitment Status : Recruiting
First Posted : September 28, 2018
Last Update Posted : October 11, 2018
Sponsor:
Collaborator:
Salk Institute for Biological Studies
Information provided by (Responsible Party):
A/Prof Leonie Heilbronn, University of Adelaide

Brief Summary:

In this randomized trial study, the investigators will compare the glycaemic health benefits of intermittent fasting (IF) versus an energy matched daily restriction (DR) approach over 18-months, and relative to a non-active intervention control (SC) in individuals at risk of type 2 diabetes.

It is hypothesized that IF will result in greater greater improvements in glycaemia control, weight loss and improvements in body composition over 18-months.


Condition or disease Intervention/treatment Phase
PreDiabetes Other: Intermittent Fasting (IF) Other: Daily Restriction (DR) Other: standard care (SC) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 252 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Daily vs Intermittent Restriction of Energy: Randomised Controlled Trial to Reduce Diabetes Risk (DIRECT)
Actual Study Start Date : September 26, 2018
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2022

Arm Intervention/treatment
Experimental: Intermittent Fasting (IF)
3 days fasting per week
Other: Intermittent Fasting (IF)
Participants will fast 3 days per week. In fasting days, meal replacements at 30% of daily energy requirements will be provided for the first 6 months. Participants will have fortnightly nutrition assessment.

Experimental: Daily Restriction (DR)
daily energy restriction
Other: Daily Restriction (DR)
Participants are instructed to restrict energy intake by 30% of daily energy requirements. Meal replacements will be provided for the first 6 months. Participants will have fortnightly nutrition assessment.

standard care (SC)
usual care
Other: standard care (SC)
Participants will receive current practice guidelines in a static information format, will not take part in any counselling or receive meal replacements.




Primary Outcome Measures :
  1. Glycaemia [ Time Frame: 6 months ]
    Change in postprandial glucose

  2. HbA1c [ Time Frame: 6 months ]
    Change in HbA1c


Secondary Outcome Measures :
  1. Body weight [ Time Frame: 2 months, 6 months, 18 months ]
    changes in body weight in kilograms

  2. Body composition [ Time Frame: 6 months, 18 months ]
    changes in body fat mass in kilograms

  3. waist and hip circumference [ Time Frame: 2 months, 6 months, 18 months ]
    changes in waist and hip circumference

  4. blood lipids [ Time Frame: 2 months, 6 months, 18 months ]
    changes in blood lipid profile (total cholesterol, HDL-, LDL-cholesterol and triglycerides)

  5. adherence to intervention [ Time Frame: 2 months, 6 months, 18 months ]
    assessed by diet records

  6. HbA1c [ Time Frame: 2 months, 18 months ]
    Change in HbA1c

  7. blood pressure [ Time Frame: 2 months, 6 months, 18 months ]
    Changes in systolic blood pressure and diastolic blood pressure

  8. Postprandial glucose [ Time Frame: 18 months ]
    Change in postprandial glucose



Information from the National Library of Medicine

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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:

  • weight-stable (< 5 % fluctuation in their body weight for past 6-months at study entry)
  • score 12 or greater on the AUSDRISK calculator
  • HbA1c <48 mmol/L (measured at screening)

Exclusion Criteria:

  • Personal history/diagnosis (self-reported) of diabetes (type 1 or 2), major psychiatric disorders (schizophrenia, major depressive disorder, bipolar disorder, eating disorders), gastrointestinal disorders, haematological disorders (i.e. thalassemia, iron-deficiency anaemia) insomnia, or any other medical condition, deemed unstable by the study physician.
  • Participants currently taking the following medications will be excluded from participating: any medication used to lower blood glucose or antidiabetic medications (metformin, sulfonylureas, Glucagon-like peptide-1 GLP-1 analogues [i.e. exenatide], thiazolidinediones or DPP-IV inhibitors [i.e. 'gliptins']), medications affecting weight, appetite or gut motility (i.e. domperidone, cisapride, orlistat, phentermine, topiramate). Participants who are taking stable doses (i.e. > 12 months) of androgenic medications (i.e. testosterone) or SSRI's will not be excluded.
  • weight change in past 3 months (> 5% screening weight)
  • uncontrolled asthma, current fever, upper respiratory infections
  • individuals who regularly perform high intensity exercise (>2 week)
  • current intake of > 140g alcohol/week
  • current smokers of cigarettes/cigars/marijuana/e-cigarettes/vaporisers
  • current intake of any recreational drugs
  • regular blood donor
  • unable to comprehend study protocol due to English language or cognitive difficulties

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): NCT03689608


Contacts
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Contact: Amy Hutchison, PhD 8128 4862 amy.hutchison@adelaide.edu.au
Contact: Leonie Heilbronn, PhD 8128 4838 leonie.heilbronn@adelaide.edu.au

Locations
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Australia, South Australia
University of Adelaide Recruiting
Adelaide, South Australia, Australia
Contact: Leonie K Heilbronn, PhD    +61 8128 4838    leonie.heilbronn@adelaide.edu.au   
Principal Investigator: Leonie K Heilbronn, PhD         
Sponsors and Collaborators
University of Adelaide
Salk Institute for Biological Studies
Investigators
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Principal Investigator: Leonie Heilbronn, PhD The University of Adelaide
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: A/Prof Leonie Heilbronn, Associate Professor, University of Adelaide
ClinicalTrials.gov Identifier: NCT03689608    
Other Study ID Numbers: R20180319
First Posted: September 28, 2018    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by A/Prof Leonie Heilbronn, University of Adelaide:
intermittent fasting
calorie restriction
prediabetes
Additional relevant MeSH terms:
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Prediabetic State
Glucose Intolerance
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperglycemia