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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.OR

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.

Authors+Show Affiliations

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.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.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.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.Adelaide Medical School, The University of Adelaide, Adelaide, South Australia, Australia.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.Adelaide Medical School, The University of Adelaide, Adelaide, South Australia, Australia.Adelaide Medical School, The University of Adelaide, Adelaide, South Australia, Australia.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.

Pub Type(s)

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

Language

eng

PubMed ID

32057716

Citation

Teong, Xiao Tong, et al. "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." Obesity Research & Clinical Practice, vol. 14, no. 2, 2020, pp. 176-183.
Teong XT, Liu K, Hutchison AT, et al. 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;14(2):176-183.
Teong, X. T., Liu, K., Hutchison, A. T., Liu, B., Feinle-Bisset, C., Wittert, G. A., Lange, K., Vincent, A. D., & Heilbronn, L. K. (2020). 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. Obesity Research & Clinical Practice, 14(2), 176-183. https://doi.org/10.1016/j.orcp.2020.01.005
Teong XT, et al. 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. PubMed PMID: 32057716.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Teong,Xiao Tong, AU - Liu,Kai, AU - Hutchison,Amy T, AU - Liu,Bo, AU - Feinle-Bisset,Christine, AU - Wittert,Gary A, AU - Lange,Kylie, AU - Vincent,Andrew D, AU - Heilbronn,Leonie K, Y1 - 2020/02/11/ PY - 2019/11/11/received PY - 2019/12/12/revised PY - 2020/01/10/accepted PY - 2020/2/15/pubmed PY - 2021/3/27/medline PY - 2020/2/15/entrez KW - Calorie restriction KW - Diabetes KW - Glycaemic control KW - Intermittent fasting KW - Obesity SP - 176 EP - 183 JF - Obesity research & clinical practice JO - Obes Res Clin Pract VL - 14 IS - 2 N2 - 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. SN - 1871-403X UR - https://www.unboundmedicine.com/medline/citation/32057716/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_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1871-403X(19)30677-5 DB - PRIME DP - Unbound Medicine ER -