search
Back to results

Does Time Restricted Feeding Improve Glycaemic Control in Overweight Men? (RESHAPE2)

Primary Purpose

Type2 Diabetes, Insulin Resistance

Status
Terminated
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
TRF
Sponsored by
University of Adelaide
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Type2 Diabetes

Eligibility Criteria

45 Years - 70 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

overweight (BMI >25.0 kg/m2) Waist circumference >102 cm

Exclusion Criteria:

  • Personal history of cardiovascular disease, diabetes, major psychiatric disorders, insomnia
  • use of prescribed or non-prescribed medications which may affect energy metabolism, gastrointestinal function, weight or appetite (e.g. domperidone and cisapride, anticholinergic drugs (e.g. atropine), androgenic medications (e.g. testosterone), metoclopramide, orlistat, diuretics)
  • use of prescribed glucose-lowering/antidiabetic medication (e.g. metformin, DPP4 inhibitors)
  • recent weight change in past 3 months, and/or does not habitually eat breakfast
  • 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
  • current intake of any illicit substance
  • current shift worker
  • has donated blood within past 3-months
  • unable to comprehend study protocol
  • does not own a smartphone

Sites / Locations

  • Adelaide Medical School

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TRF

Arm Description

Outcomes

Primary Outcome Measures

Change in glycaemia
Change in fasting and postprandial blood glucose following a standard meal test

Secondary Outcome Measures

Change in HbA1c
Change in body weight
changes in body weight (kg)
Change in waist and hip circumference
changes in waist and hip circumference (cm) and waist:hip ratio
Change in insulin
changes in fasting insulin and insulin response to a standard meal
Change in gut peptides
changes in fasting gut peptides and gut peptide responses to a standard meal
Change in cardiovascular risk
changes in blood pressure, blood lipids after 6 weeks of intervention
Change in appetite
changes in measures of appetite in response to a standard meal
Change in food intake
Change in quantity and nutritional composition of food intake

Full Information

First Posted
September 7, 2017
Last Updated
May 23, 2018
Sponsor
University of Adelaide
Collaborators
Salk Institute for Biological Studies
search

1. Study Identification

Unique Protocol Identification Number
NCT03278236
Brief Title
Does Time Restricted Feeding Improve Glycaemic Control in Overweight Men?
Acronym
RESHAPE2
Official Title
Does Time Restricted Feeding Improve Glycaemic Control in Overweight Men?
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Terminated
Why Stopped
Insufficient funding to complete pilot.
Study Start Date
September 21, 2017 (Actual)
Primary Completion Date
December 1, 2017 (Actual)
Study Completion Date
December 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Adelaide
Collaborators
Salk Institute for Biological Studies

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Obesity is a serious medical condition, the adverse consequences of which include increased risk of cardiovascular disease, diabetes mellitus, reduced fertility and cancer. The economic cost of obesity was placed at $58 billion dollars in Australia in 2008 [1]. Studies in mice and non-human primates have shown that moderate caloric restriction (CR) increases lifespan and reduces the incidence of cardiovascular disease, cancer, and type 2 diabetes [2]. Reduced risk of chronic diseases is also observed in humans following CR [3]. However, daily CR is difficult to maintain long term, since the body defends against weight loss by inducing "metabolic adaptation"[3] and altering the hormonal appetite response [4]. An emerging number of studies are examining the effects of limiting food intake to prescribed time periods per day, or every other day. Time restricted feeding (TRF) describes a dieting approach where food is available ad libitum, however only for a limited period of time (i.e. 3-12 hours). This pilot study will examine the effects of restricting daily food intake to within a 10 hour period on glycaemic control, body weight and biomarkers of metabolic health for 6-weeks. This study will build on the existing knowledge base in humans as to whether meal timing, rather than caloric restriction per se, is important to provide the stimulus required to improve metabolic health and reduce risk of chronic disease.
Detailed Description
The timing of meals distributed across the wake cycle may play a role in body weight regulation and metabolic health. In rodents, providing an 12 h feeding opportunity during the active phase abrogated the metabolic consequences of a high fat diet, including maintaining leaner body weight and normal glucose homeostasis [5]. In diet-induced obese rodents, switching to a TRF protocol normalised the metabolic milieu by reducing hyperinsulinemia, hepatic steatosis, and inflammation [6]. Interestingly, when lean animals were switched to a TRF high fat diet protocol, which allowed ad libitum access to the high fat diet for 2 consecutive days per week, simulating a "weekend", lean body weights and metabolic profiles were maintained [6]. These studies suggest that following a TRF protocol is of significant benefit to prevent weight gain, and or to normalise the metabolic milieu. Observational studies of individuals who undertook the Islamic ritual of fasting during the month of Ramadan [7, 8]. Under these conditions, not only is the timing of food intake restricted, but feeding times are switched to non-daylight hours. The outcomes from these observational studies are mixed, but many have observed reduced cardiovascular risk factors [7, 8]. However, beneficial changes in glycaemic profile are more controversial. One study, using continuous glucose monitors, reported there was a change in the pattern of the glycaemic profile, but no change in overall glycaemia [9]. Other studies have noted that fasting glucose levels are increased following Ramadan [7]. Epidemiological evidence shows that individuals who report consuming more of their daily energy intake at the evening meal were more overweight, than those who reported consumed more of their energy intake before lunch[10]. Similarly, eating lunch late in the day (after 15:00 hrs) was predictive of poorer weight loss during a 20-week dietary intervention study [11] and individuals randomized to consume more calories at breakfast had greater weight loss versus those randomized to eat more calories at dinner after 12 weeks [12]. Taken together these data suggest that consuming more calories in the morning may be beneficial for weight management. Only a limited number of controlled studies have interrogated the effects of TRF in humans [13-15]. The first was a randomised controlled cross-over intervention, where lean individuals were instructed either to consume all of their calories required for weight maintenance over a 4 hour period from 1700-2100h, or as 3 meals/d for 8 weeks. Consumption of the evening meal was supervised within the laboratory, to ensure subjects consumed the entire meal. Significant reductions in body weight and body fat mass, by 1.4 and 2.1 kg respectively, were noted when following the TRF protocol [13]. Despite this small amount of weight loss, fasting blood glucose levels were increased, and TRF resulted in poorer glucose tolerance in response to an oral glucose tolerance test (OGTT) [14]. Thus, consuming a single, large "dinner" meal was detrimental for metabolic health, although no differences in insulin response were noted [14]. Gill et al also examined the effects of 10-11h TRF in 8 men who were overweight and reported an habitual eating pattern that usually spanned at least 14 hours. A 3% body weight loss was observed after 2 months of TRF, and this was maintained for 12 months[16]. It is unclear whether responses may have differed if the food allowance was prescribed at breakfast or lunch times. Finally, healthy, lean male subjects were allowed to eat ad libitum for 13h per day (6am-7pm) for 2 weeks. Participants reported eating significantly less on the TRF versus the control condition, and lost -0.4kg compared with a gain of +0.6kg in the control condition [15]. Whilst this is a minor change in body weight, this pattern is not that atypical of modern eating patterns, and further restriction of eating times, and assessment of obese individuals under these conditions is warranted. The metabolic health impacts were not reported in either of these studies. Screening visit (S) - (Informed consent, screening questionnaire): Participants will be assessed by a screening questionnaire (provided for review) for risk of type 2 diabetes, and for their diet, medical and exercise history to determine their eligibility. Potentially eligible participants will be invited to attend SAHMRI and have the research protocol explained to them in detail. Informed consent to participate in the study, including a verbal indication that they understand the general study protocol and requirements is then obtained. Routine clinical checks are then performed (weight, height, waist circumference, blood pressure). If participants meet the eligibility criteria, they will be invited to take part in the study. Baseline assessment and food intake monitoring: In this study, we will use a smartphone-based monitoring and feedback tool (MyCircadianClock app) to monitor the daily pattern of ingestive behaviour, activity and sleep patterns for 1-week, at baseline as well as during weeks 1,3 and 5. This app was developed by our collaborators at Salk Institute, Professor Satchidananda Panda and Dr Emily Manoogian. Participants in our study will be asked to sign up to the MyCircadianClock smartphone app and using the app are asked to take a photograph of any food and drink that they consume, which time stamps when and what was eaten, for later analysis. This app is part of a study conducted by Professor Panda. The Panda lab will share the identifiable data collected through the app from participants of this study, once they have received verification of informed consent from the participant in our study to do so. This is outlined on page 4 of the SIS and consent asked on page 7 of the SIS/consent form. We have attached IRB approval of the MyCircadianClock study, which explains the app in detail. TRF: Participants will be instructed to consume their habitual diet within a self-selected 10 hour period every day. Outside of the selected eating period, participants are allowed to consume water (encouraged to drink 6-8 glasses per day) and calorie free foods (e.g. sugar-free drinks and chewing gum) as well as black coffee and/or tea. Participants will track their energy intake using the application described above. This will track compliance, and allow us to assess changes in intake. Metabolic Testing (W0, W6): Participants will be provided with a standardised meal that provides ~30% of their estimated total daily energy requirement (McCains Lasagne, fruit salad, muesli bar) to consume the evening prior to the study visit, by 1930h. They will arrive at 0730 at the Research Unit following a 12 hour overnight fast. Weight, waist and hip circumference and blood pressure will be measured and a 20G cannula inserted into an antecubital vein. A fasting blood sample (20 mL) is drawn for baseline measurements and to assess HbA1c. A second fasting blood sample (20ml) will be taken immediately prior to consuming a standardised 700kcal liquid meal (EnsurePlus ®; 57% CHO, 28 % fat, 15 % protein) (t=0). 6*10 mL blood samples are drawn at 15,30,60,90,120,180 minutes to measure glucose, free fatty acids, insulin, c-peptide and appetite hormones. A total volume of 100 mL blood will be collected at visit 0 and 6; with a total volume of 200 mL collected over 6 weeks. Appetite responses during the meal will be monitored using standardised visual analog scales.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type2 Diabetes, Insulin Resistance

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TRF
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
TRF
Intervention Description
Participants will be instructed to consume their habitual diet within a self-selected 10 hour period every day.
Primary Outcome Measure Information:
Title
Change in glycaemia
Description
Change in fasting and postprandial blood glucose following a standard meal test
Time Frame
3 hours
Secondary Outcome Measure Information:
Title
Change in HbA1c
Time Frame
6 weeks
Title
Change in body weight
Description
changes in body weight (kg)
Time Frame
6 weeks
Title
Change in waist and hip circumference
Description
changes in waist and hip circumference (cm) and waist:hip ratio
Time Frame
6 weeks
Title
Change in insulin
Description
changes in fasting insulin and insulin response to a standard meal
Time Frame
3 hours
Title
Change in gut peptides
Description
changes in fasting gut peptides and gut peptide responses to a standard meal
Time Frame
3 hours
Title
Change in cardiovascular risk
Description
changes in blood pressure, blood lipids after 6 weeks of intervention
Time Frame
6 weeks
Title
Change in appetite
Description
changes in measures of appetite in response to a standard meal
Time Frame
3 hours
Title
Change in food intake
Description
Change in quantity and nutritional composition of food intake
Time Frame
6 weeks

10. Eligibility

Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: overweight (BMI >25.0 kg/m2) Waist circumference >102 cm Exclusion Criteria: Personal history of cardiovascular disease, diabetes, major psychiatric disorders, insomnia use of prescribed or non-prescribed medications which may affect energy metabolism, gastrointestinal function, weight or appetite (e.g. domperidone and cisapride, anticholinergic drugs (e.g. atropine), androgenic medications (e.g. testosterone), metoclopramide, orlistat, diuretics) use of prescribed glucose-lowering/antidiabetic medication (e.g. metformin, DPP4 inhibitors) recent weight change in past 3 months, and/or does not habitually eat breakfast 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 current intake of any illicit substance current shift worker has donated blood within past 3-months unable to comprehend study protocol does not own a smartphone
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leonie Heilbronn, PhD
Organizational Affiliation
University of Adelaide
Official's Role
Principal Investigator
Facility Information:
Facility Name
Adelaide Medical School
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5005
Country
Australia

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Food intake data obtained from the MyCircadianApp will be shared between the researchers and the collaborators.

Learn more about this trial

Does Time Restricted Feeding Improve Glycaemic Control in Overweight Men?

We'll reach out to this number within 24 hrs