Overweight and ObesityRESETNCT03854656
Effect of Time-restricted Eating on Behaviour and Metabolism in Overweight Individuals at High Risk of Type 2 Diabetes
A study testing Time-restricted eating in people with Overweight and Obesity and PreDiabetes, run by Kristine Færch at 1 site in Denmark.
Trial summary
The aim of the present study is to investigate effects of 12 weeks time-restricted eating on behaviour and metabolism in individuals with overweight or obesity at high risk of type 2 diabetes. Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity, PreDiabetes
- What is being tested?
- Time-restricted eating
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteDenmark
- Study dates
- 25 Feb 2019to 2 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI ≥30 kg/m2 or BMI ≥25 kg/m2 in combination with pre-diabetes (HbA1c ≥39-<48 mmol/mol)
- Habitual eating/drinking window ≥12 hours (including foods/snacks and energy containing beverages e.g. soft drinks (except of water)) and an eating/drinking window of ≥14 hours minimum one day per week
Who cannot join
- Daily smoking
- For women: pregnancy, planned pregnancy (within the study period) or lactating
- Frequent travels over time zones (max one return trip/travel over times zones (˃one hour time difference) during the 13 weeks intervention).
- Shift work or partner engaged in shift work (if it affects the person's sleep and eating pattern)
- Unable to understand the informed consent and the study procedures
- Self-reported history of an eating disorder during the past three years
Show all 22Show fewer
- Self-reported weight change (>5 kg) within three months prior to inclusion
- Diabetes
- HbA1c ≥48 mmol/mol
- Uncontrolled medical issues including but not limited to cardiovascular pulmonary, rheumatologic, hematologic, oncologic, infectious, gastrointestinal or psychiatric disease; diabetes or other endocrine disease; immunosuppression
- Current treatment with medication or medical devices which significantly affect glucose metabolism, appetite, or energy balance
- Current treatment with antidepressants
- Bariatric surgery
- Implanted or portable electro-mechanical medical device such as a cardiac pacemaker, defibrillator or infusion pump
- Celiac disease, Crohn's disease, ulcerative colitis or proctitis
- Alcohol/drug abuse or in treatment with disulfiram at time of inclusion
- Concomitant participation in other intervention studies
- Not able to eat ≥85% of the test meal because of e.g. allergy
- Specific exclusion criteria for participants receiving SmartPillTM (n=60)
- Gastrointestinal symptoms or diseases such as regular (weekly) abdominal pain, dysphagia, gastric bezoars, strictures, fistulas, bowel obstructions or diverticulitis
- Current treatment with medication or medical devices which significantly affect gastrointestinal motility or transit time (prokinetics, antidiarrheals, laxatives, or opioids)
- Gastrointestinal surgery within 3 months before inclusion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Time-restricted Eating on Behaviour and Metabolism in Overweight Individuals at High Risk of Type 2 Diabetes - the RESET Study
The aim of the present study is to investigate effects of 12 weeks time-restricted eating on behaviour and metabolism in individuals with overweight or obesity at high risk of type 2 diabetes.
Read the detailed description
Overweight and obese individuals with pre-diabetes or with a family history of diabetes or cardiovascular disease (CVD) are at high risk for developing type 2 diabetes (T2D) and CVD. Current prevention and treatment of obesity and T2D include energy restricted diets and increased levels of physical activity; however, adequate adherence to such strategies is difficult, and maintenance is challenging for most individuals, which stresses the need for feasible and sustainable interventions.
Circadian rhythms of behaviour and metabolism are closely related to the daily light/dark cycle and sleep-wake patterns and timing of food intake and fasting periods may affect the circadian rhythms of metabolic organs. In an evolutionary perspective, the pattern of food consumption has been characterised by periods of caloric intake when food was available and subsequent periods of fasting 9. This cyclic pattern leads to cycles of absorption and storage of energy and utilisation of the energy for e.g. tissue repair, stress resistance and vitality where expression of metabolic regulators coordinates with cellular processes, leading to efficient metabolism 10. Factors including the 24-hour availability of energy-dense foods, busy time schedules, different eating and sleep patterns during weekdays and weekends (i.e. 'social jetlag') challenge the feeding-fasting paradigm. Recent data suggest that an erratic diurnal eating pattern characterised by food intake largely spread throughout hours awake (≥15 h) and a concomitant short fasting period is highly prevalent in humans and animal suggest that circadian misalignment of food intake is associated with adverse metabolic effects. A number of animal studies and a few small studies in humans have reported promising effects of time-restricted eating (TRE), without concomitant dietary restrictions, on body weight and other cardiometabolic risk factors. There is a lack of randomized controlled trials investigating effect of TRE in individuals at high risk of type 2 diabetes and cardiovascular diseases.
The aim of the present study is to investigate effects of 12 weeks TRE on behaviour and metabolism in individuals with overweight or obesity at high risk of type 2 diabetes. Maintenance will be assessed at a follow-up visit 13 weeks after completion of the trial (26 weeks). Testing will be conducted at baseline and after 6, 12, and 26 weeks. Participants are instructed to follow randomization during one week assessment periods after testing at 6 and 12 weeks. Therefore, the total duration of the intervention is 13 weeks.
- Conditions
- Overweight and Obesity, PreDiabetes
- Being tested
- Time-restricted eating
- Keywords
- Overweight, Obesity, Time-restricted eating, Prediabetes
- Medical subject headings
- Overweight, Obesity, Prediabetic State, Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time-restricted eatingOther
Participants will be instructed to eat within a self-selected 10-hour timeframe between 6AM and 8PM every day. All food/beverages except water must be consumed within the time-interval. Staff will help participants select a time-interval that fits into their daily life and optimally fulfil the following guiding principles:
- The first food item/beverage of the day should optimally be ingested at least 2 hours after usual wake-up time
- The last food item/beverage of the day should optimally be ingested at least 3 hours before usual bed time
Diet is ad libitum and with no further dietary restrictions. Participants will receive advice about a healthy lifestyle according to the national dietary recommendations from the Danish Health Authority.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Control group for 13 weeks (n=50). Participants will receive advice about a healthy lifestyle according to the national dietary recommendations from the Danish Health Authority. |
| Time-restricted eating | Experimental | Time-restricted eating for 13 weeks (n=50). In addition to the intervention, participants will receive advice about a healthy lifestyle according to the national dietary recommendations from the Danish Health Authority. Receives: Other: Time-restricted eating |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body weight (kg)
Measured in fasted state on a digital scale
Measured: Change from baseline to the end of the intervention (after 12 weeks)
Secondary outcomes (72)
Body weight (kg)
Measured on a digital scale
Measured: Changes from baseline. Fasted state at all four visits (Baseline and after 6, 12, and 26 weeks)
Body mass index (kg/m^2)
Calculated from body weight (kg) and height (m)
Measured: Changes from baseline. Fasted state at all four visits (Baseline and after 6, 12, and 26 weeks)
Fat mass (kg)
Measured by Dual-energy X-ray Absorptiometry
Measured: Changes from baseline. Fasted state at all four visits (Baseline and after 6, 12, and 26 weeks)
Fat free mass (kg)
Measured by Dual-energy X-ray Absorptiometry
Measured: Changes from baseline. Fasted state at all four visits (Baseline and after 6, 12, and 26 weeks)
Fat percentage (%)
Measured by Dual-energy X-ray Absorptiometry
Measured: Changes from baseline. Fasted state at all four visits (Baseline and after 6, 12, and 26 weeks)
Waist circumference (cm)
Measured using tape measure
Measured: Changes from baseline. Fasted state at all four visits (Baseline and after 6, 12, and 26 weeks)
Hip circumference (cm)
Measured using tape measure
Measured: Changes from baseline. Fasted state at all four visits (Baseline and after 6, 12, and 26 weeks)
HbA1c (mmol/mol and %)
Assessed from blood samples at all visits
Measured: Changes from baseline. All four visits (Baseline and after 6, 12, and 26 weeks)
Systolic blood pressure (mmHg)
Measured under resting and fasting conditions
Measured: Changes from baseline. Measured at all four visits (Baseline and after 6, 12, and 26 weeks)
Diastolic blood pressure (mmHg)
Measured under resting and fasting conditions
Measured: Changes from baseline. Measured at all four visits (Baseline and after 6, 12, and 26 weeks)
Heart rate (bpm)
Measured under resting and fasting conditions during measurements of blood pressure and in the supine position by a handheld ECG measuring device (Vagus™)
Measured: Changes from baseline. Measured at all four visits (Baseline and after 6, 12, and 26 weeks)
Resting energy expenditure (kcal/day)
Measured by indirect calorimetry under resting and fasting conditions
Measured: Changes from baseline. Measured at visits at baseline and after 12 weeks
Substrate oxidation (respiratory exchange ratio)
Measured by indirect calorimetry under resting and fasting conditions
Measured: Changes from baseline. Measured at visits at baseline and after 12 weeks
Metabolites
Fasting and postprandial (after a standard mixed breakfast meal) concentrations of metabolites including but not limited to: glucose, lipids, cholesterol, free-fatty acids, and amino acids
Measured: Changes from baseline. Measured in the blood in the fasted state at all four visits (Baseline and after 6, 12, and 26 weeks) and during a mixed meal test (4 hours) at baseline and end of the intervention (after 12 weeks)
Hormones
Fasting and postprandial (after a standard mixed breakfast meal) concentrations of hormones related to regulation of appetite, glucose and lipid metabolism (including but not limited to: insulin, glucagon, ghrelin, glucagon-like peptide-1 (GLP-1), glucose-dependent insulinotropic polypeptide (GIP) and peptide YY (PYY), leptin, fibroblast growth factor 19 (FGF-19), fibroblast growth factor 21 (FGF-21), growth differentiation factor 15 (GDF-15)).
Measured: Changes from baseline. Measured in the blood in the fasted state at all four visits (Baseline and after 6, 12, and 26 weeks) and during a mixed meal test (4 hours) at baseline and end of the intervention (after 12 weeks)
Circulating proteins that associate with low-grade inflammation and lipid metabolism
Fasting levels of circulating proteins that associate with low-grade inflammation and lipid metabolism. Such proteins are captured by mass-spectrometry driven analyses of the plasma proteome i.e. proteins circulating in the blood
Measured: Changes from baseline. Fasted state at all four visits (Baseline and after 6, 12, and 26 weeks)
Respiratory and glycolytic capacities of isolated peripheral blood mononuclear cells (PBMCs)
Measured using the Seahorse method, which measures mitochondrial respiration
Measured: Changes from baseline. Fasted state at all four visits (Baseline and after 6, 12, and 26 weeks) and during a mixed meal test at baseline and end of the intervention (after 12 weeks)
Heart rate response to standing up from the supine position
Measured by a handheld ECG measuring device (Vagus™).
Measured: Changes from baseline. Measured at visits at baseline and end of the intervention (after 12 weeks)
Heart rate response to inhalation and exhalation
Measured by a handheld ECG measuring device (Vagus™).
Measured: Changes from baseline. Measured at visits at baseline and end of the intervention (after 12 weeks)
Heart rate response to forced exhalation during rest (valsalva maneuver)
Measured by a handheld ECG measuring device (Vagus™).
Measured: Changes from baseline. Measured at visits at baseline and end of the intervention (after 12 weeks)
Gastric emptying time (hours and minutes)
Measured using the SmartPill™ technique. The SmartPill™ is ingested together with a standard mixed breakfast meal
Measured: Changes from baseline. Time after consumption of the standard mixed meal at baseline and end of the intervention (after 12 weeks).
Small bowel transit time (hours and minutes)
Measured using the SmartPill™ technique. The SmartPill™ is ingested together with a standard mixed breakfast meal
Measured: Changes from baseline. Time after consumption of the standard mixed meal at baseline and end of the intervention (after 12 weeks).
Large bowel transit time (hours and minutes)
Measured using the SmartPill™ technique. The SmartPill™ is ingested together with a standard mixed breakfast meal
Measured: Changes from baseline. Time after consumption of the standard mixed meal at baseline and end of the intervention (after 12 weeks).
Total gastrointestinal transit time (hours and minutes)
Measured using the SmartPill™ technique. The SmartPill™ is ingested together with a standard mixed breakfast meal
Measured: Changes from baseline. Time after consumption of the standard mixed meal at baseline and end of the intervention (after 12 weeks).
Motility index
Calculated based on amplitudes and number of contractions measured using the SmartPill™ technique. The SmartPill™ is ingested together with a standard mixed breakfast meal
Measured: Changes from baseline. Time after consumption of the standard mixed meal at baseline and end of the intervention (after 12 weeks).
Attention measured using eye tracking
Eye tracking metrics including gaze duration bias, gaze direction bias, fixations, saccades, pupil size/dilation, distance to screen, ocular vergence and blinks to measure attention in response to looking at food pictures during the computerized Leeds Food Preference Questionnaire
Measured: Changes from baseline. Fasted state at all four visits (Baseline and after 6, 12, and 26 weeks) and during a mixed meal test at baseline and end of the intervention (after 12 weeks)
Emotions measured using facial expression analyses
Facial expression analyses using computer-vision algorithms (AFFDEX) to measure emotions in response to looking at food pictures during the computerized Leeds Food Preference Questionnaire
Measured: Changes from baseline. Fasted state at all four visits (baseline and after 6, 12, and 26 weeks) and during a mixed meal test at baseline and end of the intervention (after 12 weeks)
Arousal measured using galvanic skin response
Changes in conductivity of the skin (galvanic skin response) in response to looking at food pictures during the computerized Leeds Food Preference Questionnaire
Measured: Changes from baseline. Fasted state at all four visits (Baseline and after 6, 12, and 26 weeks) and during a mixed meal test at baseline and end of the intervention (after 12 weeks)
Food choice
Food choice of food items from four combined food categories (high-fat savoury, high-fat sweet, low-fat savoury and low-fat sweet foods) examined from the computerized Leeds Food Preference Questionnaire. Food choice is determined based on frequency of selection made within each food category. The scores range from 0-48 i.e. 0 = foods within a specific food category have not been selected at all to 48 = foods within a specific food category have been selected 48 times
Measured: Changes from baseline. Fasted state at all four visits (Baseline and after 6, 12, and 26 weeks) and during a mixed meal test at baseline and end of the intervention (after 12 weeks)
Implicit wanting
Implicit wanting of food items from four combined food categories (high-fat savoury, high-fat sweet, low-fat savoury and low-fat sweet foods) examined from the computerized Leeds Food Preference Questionnaire. Implicit wanting is assessed based on food choice and response time for selected and non-selected food items as well as mean response time.
Measured: Changes from baseline. Fasted state at all four visits (Baseline and after 6, 12, and 26 weeks) and during a mixed meal test at baseline and end of the intervention (after 12 weeks)
Explicit liking
Explicit liking of 16 food items from four combined food categories (high-fat savoury, high-fat sweet, low-fat savoury and low-fat sweet foods) examined from the computerized Leeds Food Preference Questionnaire. Explicit liking is rated using visual analogue scales and the range is 0-100. Each end represents the extremes e.g. Question: "how pleasant would it be to taste this food right now?" Answer: "not at all" (rated 0 on the 0-100 scale) to "extremely" (rated 100 on the 0-100 scale)
Measured: Changes from baseline. Fasted state at all four visits (Baseline and after 6, 12, and 26 weeks) and during a mixed meal test at baseline and end of the intervention (after 12 weeks)
Explicit wanting
Explicit wanting of 16 food items from four combined food categories (high-fat savoury, high-fat sweet, low-fat savoury and low-fat sweet foods) examined from the computerized Leeds Food Preference Questionnaire. Explicit wanting is rated using visual analogue scales and the range is 0-100. Each end represents the extremes e.g. Question: "how much do you want some of this food now?" Answer: "not at all" (rated 0 on the 0-100 scale) to "extremely" (rated 100 on the 0-100 scale).
Measured: Changes from baseline. Fasted state at all four visits (Baseline and after 6, 12, and 26 weeks) and during a mixed meal test at baseline and end of the intervention (after 12 weeks)
Insulin sensitivity (indices)
Including but not limited to the Matsuda index
Measured: At all four visits (Baseline and after 6, 12, and 26 weeks)
Insulin resistance (indices)
Including but not limited to Homeostaic Model Assessment for Insulin Resistance (HOMA-IR)
Measured: At all four visits (Baseline and after 6, 12, and 26 weeks)
Subjective appetite
Rated using visual analogue scales and includes sensations of: Hunger, fullness, satiety, prospective food consumption, wellbeing, nausea, thirst, desire to eat meat, salty, and sweet. The scale range is 0-100 and each end represent the extremes e.g. hunger rating: "I am not hungry at all" to "I have nerver been this hungry before".
Measured: Changes from baseline. Fasted state at all four visits (Baseline and after 6, 12, and 26 weeks) and during a mixed meal test at baseline and end of the intervention (after 12 weeks)
Mean amplitude of glycaemic excursions (MAGE)
Measured using continous glucose monitoring
Measured: Changes from baseline. Measured 7 days after the test days at baseline and after 6 and 12 weeks
Continuous overall net glycaemic action (CONGA)
Measured using continous glucose monitoring
Measured: Changes from baseline. Measured 7 days after the test days at baseline and after 6 and 12 weeks
Daily time spent above different glucose concentrations (e.g. >6.1 mmol/L, >7.0 mmol/L, >7.8 mmol/L, and >11.1 mmol/L)
Measured using continous glucose monitoring.
Measured: Changes from baseline. Measured 7 days after the test days at baseline and after 6 and 12 weeks
Mean glucose concentrations
Measured using continous glucose monitoring.
Measured: Changes from baseline. Measured 7 days after the test days at baseline and after 6 and 12 weeks
Standard deviation of glucose concentrations
Measured using continous glucose monitoring.
Measured: Changes from baseline. Measured 7 days after the test days at baseline and after 6 and 12 weeks
Variation coefficients of glucose concentrations
Measured using continous glucose monitoring.
Measured: Changes from baseline. Measured 7 days after the test days at baseline and after 6 and 12 weeks
Physical activity (time spent at different intensities)
Sedentary time, light, moderate and vigorous intensity physical activity. Assessed from 24 h/day accelerometry
Measured: Changes from baseline. Measured 7 days after the test days at baseline and after 6 and 12 weeks
Physical activity (counts/min)
Assessed from 24 h/day accelerometry
Measured: Changes from baseline. Measured 7 days after the test days at baseline and after 6 and 12 weeks
Physical activity energy expenditure (kcal/day)
Assessed from 24 h/day accelerometry
Measured: Changes from baseline. Measured 7 days after the test days at baseline and after 6 and 12 weeks
Physical activity (MET hours)
Assessed from 24 h/day accelerometry
Measured: Changes from baseline. Measured 7 days after the test days at baseline and after 6 and 12 weeks
Timing of physical activity (hh:mm)
Assessed from activity logs and 24 h/day accelerometry
Measured: Changes from baseline. Measured 7 days after the test days at baseline and after 6 and 12 weeks
Energy intake (kcal/day)
Assessed from diet records
Measured: Changes from baseline. Registered 3 days after the test days at baseline and after 6 and 12 weeks
Macronutrient intake (energy percentage)
Assessed from diet records
Measured: Changes from baseline. Registered 3 days after the test days at baseline and after 6 and 12 weeks
Timing of dietary intake (hh:mm)
Assessed from diet records
Measured: Changes from baseline. Registered 3 days after the test days at baseline and after 6 and 12 weeks
Sleep timing (hh:mm)
Including bedtime, sleep onset, wake-up, time out of bed, sleep midpoint. Assessed from sleep logs and 24 h/day accelerometry
Measured: Changes from baseline. Registered and measured for 7 days after the test days at baseline and after 6 and 12 weeks
Sleep duration (min)
Assessed from sleep logs and 24 h/day accelerometry
Measured: Changes from baseline. Registered and measured for 7 days after the test days at baseline and after 6 and 12 weeks
Sleep variability (min)
Variability in bedtime, wake-up, sleep duration and sleep midpoint. Assessed from sleep logs and 24 h/day accelerometry
Measured: Changes from baseline. Registered and measured for 7 days after the test days at baseline and after 6 and 12 weeks
Sleep onset latency (min)
Assessed from sleep logs and 24 h/day accelerometry
Measured: Changes from baseline. Registered and measured for 7 days after the test days at baseline and after 6 and 12 weeks
Sleep efficiency (%)
Assessed from 24 h/day accelerometry
Measured: Changes from baseline. Measured for 7 days after the test days at baseline and after 6 and 12 weeks
Wakefulness (min)
Assessed from 24 h/day accelerometry
Measured: Changes from baseline. Measured for 7 days after the test days at baseline and after 6 and 12 weeks
Self-reported gastrointestinal symptoms (part 1)
Assessed from the questionnaires the Gastrointestinal Symptom Rating Scale (GSRS). Rated on 7-point likert scales. Range: 1 = absence of symptoms to 7 = very severe symptoms.
Measured: Changes from baseline. Assessed at all four visits (Baseline and after 6, 12, and 26 weeks)
Self-reported gastrointestinal symptoms (part 2)
Assessed from the Gastrointestinal Symptom Score (PAGI-SYM). Rated on 6-point likert scales. Range: 1 = absence of symptoms to 6 = very severe symptoms.
Measured: Changes from baseline. Assessed at all four visits (Baseline and after 6, 12, and 26 weeks)
Self-reported gastrointestinal symptoms (part 3)
Number of symptoms. Assessed from logs.
Measured: Changes from baseline. Registered 7 days after the test days at baseline and after 12 weeks
Self-reported autonomic symptoms
Assessed from the questionnaire COMPASS31
Measured: Changes from baseline. Assessed at all four visits (Baseline and after 6, 12, and 26 weeks)
Self-reported control over eating
Assessed from the questionnaire Control over Eating Questionnaire
Measured: Changes from baseline. Assessed at all four visits (Baseline and after 6, 12, and 26 weeks)
Self-reported sleepiness
Assessed from the questionnaire the Epworth Sleepiness Scale
Measured: Changes from baseline. Assessed at all four visits (Baseline and after 6, 12, and 26 weeks)
Self-reported sleep quality
Assessed from the questionnaire Pittsburgh Sleep Quality Index
Measured: Changes from baseline. Assessed at all four visits (Baseline and after 6, 12, and 26 weeks)
Self-reported chronotype
Assessed from the Munich Chronotype Questionnaire
Measured: Changes from baseline. Assessed at all four visits (Baseline and after 6, 12, and 26 weeks)
Self-reported physical activity
Assessed from questionnaire International Physical Activity Questionnaire
Measured: Changes from baseline. Assessed at all four visits (Baseline and after 6, 12, and 26 weeks)
Self-reported overall health and wellbeing
Assessed from the questionnaire Self-reported health (SF-36 health survey)
Measured: Changes from baseline. Assessed at all four visits (Baseline and after 6, 12, and 26 weeks)
Self-reported eating behavior
Assessed from The Dutch Eating Behavior Questionnaire
Measured: Changes from baseline. Assessed at all four visits (Baseline and after 6, 12, and 26 weeks)
Self-reported night eating
Assessed from The Night Eating Questionnaire
Measured: Changes from baseline. Assessed at all four visits (Baseline and after 6, 12, and 26 weeks)
Daily eating/drinking window (hh:min)
Time of first and last meal/beverage
Measured: Registrered every day (13 weeks intervention and 13 weeks follow-up period)
Microbiome content and diversity
Determined from stool samples. Bacterial DNA and RNA will be purified from the stool samples and changes in the microbiome composition and function will be estimated based on sequencing of the microbiomes' DNA and RNA. Includes but is not limited to the Firmicute/Bacteroidete ratio.
Measured: Changes from baseline. Collected before or during test days at visits at baseline and after 12 weeks
Motivation for participation (qualitative methods)
Themes and aspects related to motivation for participation will be assessed based on interviews with the participants including completers and potential drop-outs.
Measured: Visits at baseline and after 12 and 26 weeks. Potential drop-outs will be interviewed at the specific time point.
Feasibility of the intervention (qualitative methods)
Themes and aspects related to feasibility of the intervention will be assessed based on interviews with the participants including completers and potential drop-outs.
Measured: Visits at baseline and after 12 and 26 weeks. Potential drop-outs will be interviewed at the specific time point.
Satisfaction with the intervention (qualitative methods)
Themes and aspects related to satisfaction with the intervention will be assessed based on interviews with the participants including completers and potential drop-outs.
Measured: Visits at baseline and after 12 and 26 weeks. Potential drop-outs will be interviewed at the specific time point.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2019
- Study start25 Feb 2019
- Primary completion2 Mar 2022
- Study completion2 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kristine Færch
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen, Aalborg University Hospital, IMotions A/S, University of Leeds, Salk Institute for Biological Studies
- Responsible party
- Sponsor-investigator, Kristine Færch, Steno Diabetes Center Copenhagen
- Investigators
- Kristine Færch, PhD, Principal investigator, Steno Diabetes Center Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03854656
- Sponsor's protocol ID
- NNF17OC0027822
- Acronym
- RESET
- Status last verified
- Mar 2022
- First submitted
- 18 Feb 2019
- Last updated
- 18 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Quist JS, Pedersen HE, Jensen MM, Clemmensen KKB, Bjerre N, Ekblond TS, Uldal S, Storling J, Wewer Albrechtsen NJ, Holst JJ, Torekov SS, Nyeland ME, Vistisen D, Jorgensen ME, Panda S, Brock C, Finlayson G, Blond MB, Faerch K. Effects of 3 months of 10-h per-day time-restricted eating and 3 months of follow-up on bodyweight and cardiometabolic health in Danish individuals at high risk of type 2 diabetes: the RESET single-centre, parallel, superiority, open-label, randomised controlled trial. Lancet Healthy Longev. 2024 May;5(5):e314-e325. doi: 10.1016/S2666-7568(24)00028-X. Epub 2024 Apr 5.
PubMed 38588687Jensen MM, Pedersen HE, Clemmensen KKB, Ekblond TS, Ried-Larsen M, Faerch K, Brock C, Quist JS. Associations Between Physical Activity and Gastrointestinal Transit Times in People with Normal Weight, Overweight, and Obesity. J Nutr. 2024 Jan;154(1):41-48. doi: 10.1016/j.tjnut.2023.06.005. Epub 2023 Jun 12.
PubMed 37315794Quist JS, Jensen MM, Clemmensen KKB, Pedersen H, Bjerre N, Storling J, Blond MB, Wewer Albrechtsen NJ, Holst JJ, Torekov SS, Vistisen D, Jorgensen ME, Panda S, Brock C, Finlayson G, Faerch K. Protocol for a single-centre, parallel-group, randomised, controlled, superiority trial on the effects of time-restricted eating on body weight, behaviour and metabolism in individuals at high risk of type 2 diabetes: the REStricted Eating Time (RESET) study. BMJ Open. 2020 Aug 26;10(8):e037166. doi: 10.1136/bmjopen-2020-037166.
PubMed 32847912
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Time-restricted Eating on Behaviour and Metabolism in Overweight Individuals at High Risk of Type 2 Diabetes - the RESET Study
- ClinicalTrials.gov ID
- NCT03854656
- Acronym / sponsor ID
- RESET / NNF17OC0027822
- Conditions
- Overweight and Obesity, PreDiabetes
- Keywords
- Overweight, Obesity, Time-restricted eating, Prediabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Kristine FærchUniversity, hospital or other
- Collaborators
- University of Copenhagen, Aalborg University Hospital, IMotions A/S, University of Leeds, Salk Institute for Biological Studies
- Study start
- 25 Feb 2019 (actual)
- Primary completion
- 2 Mar 2022 (actual)
- Study completion
- 2 Mar 2022 (actual)
- First posted
- 26 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the present study is to investigate effects of 12 weeks time-restricted eating on behaviour and metabolism in individuals with overweight or obesity at high risk of type 2 diabetes.
Detailed description
Overweight and obese individuals with pre-diabetes or with a family history of diabetes or cardiovascular disease (CVD) are at high risk for developing type 2 diabetes (T2D) and CVD. Current prevention and treatment of obesity and T2D include energy restricted diets and increased levels of physical activity; however, adequate adherence to such strategies is difficult, and maintenance is challenging for most individuals, which stresses the need for feasible and sustainable interventions.
Circadian rhythms of behaviour and metabolism are closely related to the daily light/dark cycle and sleep-wake patterns and timing of food intake and fasting periods may affect the circadian rhythms of metabolic organs. In an evolutionary perspective, the pattern of food consumption has been characterised by periods of caloric intake when food was available and subsequent periods of fasting 9. This cyclic pattern leads to cycles of absorption and storage of energy and utilisation of the energy for e.g. tissue repair, stress resistance and vitality where expression of metabolic regulators coordinates with cellular processes, leading to efficient metabolism 10. Factors including the 24-hour availability of energy-dense foods, busy time schedules, different eating and sleep patterns during weekdays and weekends (i.e. 'social jetlag') challenge the feeding-fasting paradigm. Recent data suggest that an erratic diurnal eating pattern characterised by food intake largely spread throughout hours awake (≥15 h) and a concomitant short fasting period is highly prevalent in humans and animal suggest that circadian misalignment of food intake is associated with adverse metabolic effects. A number of animal studies and a few small studies in humans have reported promising effects of time-restricted eating (TRE), without concomitant dietary restrictions, on body weight and other cardiometabolic risk factors. There is a lack of randomized controlled trials investigating effect of TRE in individuals at high risk of type 2 diabetes and cardiovascular diseases.
The aim of the present study is to investigate effects of 12 weeks TRE on behaviour and metabolism in individuals with overweight or obesity at high risk of type 2 diabetes. Maintenance will be assessed at a follow-up visit 13 weeks after completion of the trial (26 weeks). Testing will be conducted at baseline and after 6, 12, and 26 weeks. Participants are instructed to follow randomization during one week assessment periods after testing at 6 and 12 weeks. Therefore, the total duration of the intervention is 13 weeks.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Control group for 13 weeks (n=50). Participants will receive advice about a healthy lifestyle according to the national dietary recommendations from the Danish Health Authority. |
| Time-restricted eating | Experimental | Other: Time-restricted eatingTime-restricted eating for 13 weeks (n=50). In addition to the intervention, participants will receive advice about a healthy lifestyle according to the national dietary recommendations from the Danish Health Authority. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- BMI ≥30 kg/m2 or BMI ≥25 kg/m2 in combination with pre-diabetes (HbA1c ≥39-<48 mmol/mol)
- Habitual eating/drinking window ≥12 hours (including foods/snacks and energy containing beverages e.g. soft drinks (except of water)) and an eating/drinking window of ≥14 hours minimum one day per week
Key exclusion criteria (22 listed)
- Daily smoking
- For women: pregnancy, planned pregnancy (within the study period) or lactating
- Frequent travels over time zones (max one return trip/travel over times zones (˃one hour time difference) during the 13 weeks intervention).
- Shift work or partner engaged in shift work (if it affects the person's sleep and eating pattern)
- Unable to understand the informed consent and the study procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Time-restricted eatingParticipants will be instructed to eat within a self-selected 10-hour timeframe between 6AM and 8PM every day. All food/beverages except water must be consumed within the time-interval. Staff will help participants select a time-interval that fits into their daily life and optimally fulfil the following guiding principles: 1. The first food item/beverage of the day should optimally be ingested at least 2 hours after usual wake-up time 2. The last food item/beverage of the day should optimally be ingested at least 3 hours before usual bed time Diet is ad libitum and with no further dietary restrictions. Participants will receive advice about a healthy lifestyle according to the national dietary recommendations from the Danish Health Authority. | Other | Time-restricted eating |
Primary outcome
Change in body weight (kg)
Time frame: Change from baseline to the end of the intervention (after 12 weeks)
Measured in fasted state on a digital scale
72 secondary outcomes
Body weight (kg)
Time frame: Changes from baseline. Fasted state at all four visits (Baseline and after 6, 12, and 26 weeks)
Body mass index (kg/m^2)
Time frame: Changes from baseline. Fasted state at all four visits (Baseline and after 6, 12, and 26 weeks)
Fat mass (kg)
Time frame: Changes from baseline. Fasted state at all four visits (Baseline and after 6, 12, and 26 weeks)
Fat free mass (kg)
Time frame: Changes from baseline. Fasted state at all four visits (Baseline and after 6, 12, and 26 weeks)
Fat percentage (%)
Time frame: Changes from baseline. Fasted state at all four visits (Baseline and after 6, 12, and 26 weeks)
Waist circumference (cm)
Time frame: Changes from baseline. Fasted state at all four visits (Baseline and after 6, 12, and 26 weeks)
Hip circumference (cm)
Time frame: Changes from baseline. Fasted state at all four visits (Baseline and after 6, 12, and 26 weeks)
HbA1c (mmol/mol and %)
Time frame: Changes from baseline. All four visits (Baseline and after 6, 12, and 26 weeks)
Systolic blood pressure (mmHg)
Time frame: Changes from baseline. Measured at all four visits (Baseline and after 6, 12, and 26 weeks)
Diastolic blood pressure (mmHg)
Time frame: Changes from baseline. Measured at all four visits (Baseline and after 6, 12, and 26 weeks)
Heart rate (bpm)
Time frame: Changes from baseline. Measured at all four visits (Baseline and after 6, 12, and 26 weeks)
Resting energy expenditure (kcal/day)
Time frame: Changes from baseline. Measured at visits at baseline and after 12 weeks
Substrate oxidation (respiratory exchange ratio)
Time frame: Changes from baseline. Measured at visits at baseline and after 12 weeks
Metabolites
Time frame: Changes from baseline. Measured in the blood in the fasted state at all four visits (Baseline and after 6, 12, and 26 weeks) and during a mixed meal test (4 hours) at baseline and end of the intervention (after 12 weeks)
Hormones
Time frame: Changes from baseline. Measured in the blood in the fasted state at all four visits (Baseline and after 6, 12, and 26 weeks) and during a mixed meal test (4 hours) at baseline and end of the intervention (after 12 weeks)
Circulating proteins that associate with low-grade inflammation and lipid metabolism
Time frame: Changes from baseline. Fasted state at all four visits (Baseline and after 6, 12, and 26 weeks)
Respiratory and glycolytic capacities of isolated peripheral blood mononuclear cells (PBMCs)
Time frame: Changes from baseline. Fasted state at all four visits (Baseline and after 6, 12, and 26 weeks) and during a mixed meal test at baseline and end of the intervention (after 12 weeks)
Heart rate response to standing up from the supine position
Time frame: Changes from baseline. Measured at visits at baseline and end of the intervention (after 12 weeks)
Heart rate response to inhalation and exhalation
Time frame: Changes from baseline. Measured at visits at baseline and end of the intervention (after 12 weeks)
Heart rate response to forced exhalation during rest (valsalva maneuver)
Time frame: Changes from baseline. Measured at visits at baseline and end of the intervention (after 12 weeks)
Gastric emptying time (hours and minutes)
Time frame: Changes from baseline. Time after consumption of the standard mixed meal at baseline and end of the intervention (after 12 weeks).
Small bowel transit time (hours and minutes)
Time frame: Changes from baseline. Time after consumption of the standard mixed meal at baseline and end of the intervention (after 12 weeks).
Large bowel transit time (hours and minutes)
Time frame: Changes from baseline. Time after consumption of the standard mixed meal at baseline and end of the intervention (after 12 weeks).
Total gastrointestinal transit time (hours and minutes)
Time frame: Changes from baseline. Time after consumption of the standard mixed meal at baseline and end of the intervention (after 12 weeks).
Motility index
Time frame: Changes from baseline. Time after consumption of the standard mixed meal at baseline and end of the intervention (after 12 weeks).
Attention measured using eye tracking
Time frame: Changes from baseline. Fasted state at all four visits (Baseline and after 6, 12, and 26 weeks) and during a mixed meal test at baseline and end of the intervention (after 12 weeks)
Emotions measured using facial expression analyses
Time frame: Changes from baseline. Fasted state at all four visits (baseline and after 6, 12, and 26 weeks) and during a mixed meal test at baseline and end of the intervention (after 12 weeks)
Arousal measured using galvanic skin response
Time frame: Changes from baseline. Fasted state at all four visits (Baseline and after 6, 12, and 26 weeks) and during a mixed meal test at baseline and end of the intervention (after 12 weeks)
Food choice
Time frame: Changes from baseline. Fasted state at all four visits (Baseline and after 6, 12, and 26 weeks) and during a mixed meal test at baseline and end of the intervention (after 12 weeks)
Implicit wanting
Time frame: Changes from baseline. Fasted state at all four visits (Baseline and after 6, 12, and 26 weeks) and during a mixed meal test at baseline and end of the intervention (after 12 weeks)
Explicit liking
Time frame: Changes from baseline. Fasted state at all four visits (Baseline and after 6, 12, and 26 weeks) and during a mixed meal test at baseline and end of the intervention (after 12 weeks)
Explicit wanting
Time frame: Changes from baseline. Fasted state at all four visits (Baseline and after 6, 12, and 26 weeks) and during a mixed meal test at baseline and end of the intervention (after 12 weeks)
Insulin sensitivity (indices)
Time frame: At all four visits (Baseline and after 6, 12, and 26 weeks)
Insulin resistance (indices)
Time frame: At all four visits (Baseline and after 6, 12, and 26 weeks)
Subjective appetite
Time frame: Changes from baseline. Fasted state at all four visits (Baseline and after 6, 12, and 26 weeks) and during a mixed meal test at baseline and end of the intervention (after 12 weeks)
Mean amplitude of glycaemic excursions (MAGE)
Time frame: Changes from baseline. Measured 7 days after the test days at baseline and after 6 and 12 weeks
Continuous overall net glycaemic action (CONGA)
Time frame: Changes from baseline. Measured 7 days after the test days at baseline and after 6 and 12 weeks
Daily time spent above different glucose concentrations (e.g. >6.1 mmol/L, >7.0 mmol/L, >7.8 mmol/L, and >11.1 mmol/L)
Time frame: Changes from baseline. Measured 7 days after the test days at baseline and after 6 and 12 weeks
Mean glucose concentrations
Time frame: Changes from baseline. Measured 7 days after the test days at baseline and after 6 and 12 weeks
Standard deviation of glucose concentrations
Time frame: Changes from baseline. Measured 7 days after the test days at baseline and after 6 and 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2022.
- Derived from this study: PubMed 38588687Quist JS, Pedersen HE, Jensen MM, Clemmensen KKB, Bjerre N, Ekblond TS, Uldal S, Storling J, Wewer Albrechtsen NJ, Holst JJ, Torekov SS, Nyeland ME, Vistisen D, Jorgensen ME, Panda S, Brock C, Finlayson G, Blond MB, Faerch K. Effects of 3 months of 10-h per-day time-restricted eating and 3 months of follow-up on bodyweight and cardiometabolic health in Danish individuals at high risk of type 2 diabetes: the RESET single-centre, parallel, superiority, open-label, randomised controlled trial. Lancet Healthy Longev. 2024 May;5(5):e314-e325. doi: 10.1016/S2666-7568(24)00028-X. Epub 2024 Apr 5.
- Derived from this study: PubMed 37315794Jensen MM, Pedersen HE, Clemmensen KKB, Ekblond TS, Ried-Larsen M, Faerch K, Brock C, Quist JS. Associations Between Physical Activity and Gastrointestinal Transit Times in People with Normal Weight, Overweight, and Obesity. J Nutr. 2024 Jan;154(1):41-48. doi: 10.1016/j.tjnut.2023.06.005. Epub 2023 Jun 12.
- Derived from this study: PubMed 32847912Quist JS, Jensen MM, Clemmensen KKB, Pedersen H, Bjerre N, Storling J, Blond MB, Wewer Albrechtsen NJ, Holst JJ, Torekov SS, Vistisen D, Jorgensen ME, Panda S, Brock C, Finlayson G, Faerch K. Protocol for a single-centre, parallel-group, randomised, controlled, superiority trial on the effects of time-restricted eating on body weight, behaviour and metabolism in individuals at high risk of type 2 diabetes: the REStricted Eating Time (RESET) study. BMJ Open. 2020 Aug 26;10(8):e037166. doi: 10.1136/bmjopen-2020-037166.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristine Færch, PhD principal investigator
Steno Diabetes Center Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Time-restricted eating in people with Overweight and Obesity and PreDiabetes, run by Kristine Færch at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in body weight (kg) (time frame: Change from baseline to the end of the intervention (after 12 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03854656, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2022.