Rationale and protocol for a randomized controlled trial comparing daily calorie restriction versus intermittent fasting to improve glycaemia in individuals at increased risk of developing type 2 diabetes

Xiao Tong Teong; Kai Liu; Amy T Hutchison; Bo Liu; Christine Feinle-Bisset; Gary A Wittert; Kylie Lange; Andrew D Vincent; Leonie K Heilbronn

doi:10.1016/j.orcp.2020.01.005

Rationale and protocol for a randomized controlled trial comparing daily calorie restriction versus intermittent fasting to improve glycaemia in individuals at increased risk of developing type 2 diabetes

Obes Res Clin Pract. 2020 Mar-Apr;14(2):176-183. doi: 10.1016/j.orcp.2020.01.005. Epub 2020 Feb 11.

Authors

Xiao Tong Teong¹, Kai Liu¹, Amy T Hutchison¹, Bo Liu¹, Christine Feinle-Bisset², Gary A Wittert¹, Kylie Lange², Andrew D Vincent², Leonie K Heilbronn³

Affiliations

¹ Adelaide Medical School, The University of Adelaide, Adelaide, South Australia, Australia; Lifelong Health Theme, South Australia Health and Medical Research Institute (SAHMRI), Adelaide, South Australia, Australia.
² Adelaide Medical School, The University of Adelaide, Adelaide, South Australia, Australia.
³ Adelaide Medical School, The University of Adelaide, Adelaide, South Australia, Australia; Lifelong Health Theme, South Australia Health and Medical Research Institute (SAHMRI), Adelaide, South Australia, Australia. Electronic address: leonie.heilbronn@adelaide.edu.au.

PMID: 32057716
DOI: 10.1016/j.orcp.2020.01.005

Abstract

Background: Intermittent fasting (IF) is proposed as a viable alternative to moderate calorie restriction (CR) for weight loss and metabolic health, but few long term randomized trials have been conducted. This protocol paper describes the rationale and detailed protocol for DIRECT study (Daily versus Intermittent Restriction of Energy: Controlled Trial to Reduce Diabetes Risk), comparing long term effectiveness of IF versus CR on metabolic health in individuals who are at increased risk of developing type 2 diabetes.

Methods: Anticipated 260 non-diabetic men and women aged 35-75 years, BMI 25-50 kg/m² with score ≥12 on the Australian Diabetes Risk (AUSDRISK) calculator will be recruited into this open-label, multi-arm, parallel group sequential randomized controlled trial. Participants will be randomized to one of three groups for 18 months: IF (30% of energy needs on fast days), CR (70% of energy needs daily), or standard care (SC) group. All participants will visit the clinic fortnightly for weight assessments during active intervention phase (6 months), followed by a 12-month follow-up phase. IF and CR groups will receive further diet counselling by dietitian. Two primary outcomes are the changes in glycated haemoglobin (HbA1c) and postprandial glucose area under the curve (AUC) at week 24 post-randomization. Secondary outcomes include changes in weight, body composition via dual-energy X-ray absorptiometry, gastro-intestinal hormones, cardiovascular risk factors, and dietary record by a smartphone-based application.

Discussion: This study will provide substantial evidence as to whether IF is an effective nutrition intervention for glycaemic control in a population at risk of developing type 2 diabetes.

Trial registration: ClinicalTrials.gov NCT03689608.

Keywords: Calorie restriction; Diabetes; Glycaemic control; Intermittent fasting; Obesity.

Publication types

Clinical Trial Protocol
Research Support, Non-U.S. Gov't

MeSH terms

Absorptiometry, Photon
Adult
Aged
Area Under Curve
Australia
Blood Glucose / metabolism
Body Composition
Body Weight
Caloric Restriction / methods*
Diabetes Mellitus, Type 2 / etiology
Diabetes Mellitus, Type 2 / prevention & control*
Fasting*
Female
Glycated Hemoglobin / metabolism
Glycemic Control / methods*
Humans
Male
Middle Aged
Postprandial Period / physiology
Randomized Controlled Trials as Topic
Treatment Outcome

Substances

Blood Glucose
Glycated Hemoglobin A

Associated data

ClinicalTrials.gov/NCT03689608