Obesity, Prediabetes
Conditions
Brief summary
Time-restricted eating (TRE) is a dietary manipulation that involves restricting food intake to 6-12 h/day with no food intake during the rest of the day. In animals, TRE improves metabolic function without caloric restriction. However, an understanding of the effect of TRE on cardiometabolic health in people is not clear and few studies have evaluated this issue. This study is a randomized controlled trial in people with obesity and prediabetes/insulin resistance. The overall goal of the study is to determine the effect of 9 h TRE for 12 weeks on key metabolic outcomes that are risk factors for cardiovascular disease (CVD): The goal of this study is to answer the following questions: 1) 24-hour metabolic homeostasis 2) 24h diurnal rhythm and appetite regulation.
Interventions
BEHAVIORALTime restricted eating
Participants assigned to the TRE group will have to consume all their daily meals and snacks during a 9-hour window for 12 weeks.
BEHAVIORALHealthy Eating
Participants will be provided nutrition education and counselling to follow a diet consistent with the existing guidelines for chronic disease prevention.
BEHAVIORALExtended eating window
Participants assigned to the control group will have to consume all their daily meals and snacks during a 14-hour window for 12 weeks.
BEHAVIORALHealthy diet
Participants will be provided nutrition education and counselling to follow a diet consistent with the existing guidelines for chronic disease prevention.
Sponsors
Cambridge University Hospitals NHS Foundation Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
35 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* willing and able to give informed consent for participation in the study * aged 35-75 years * men and women * body mass index 27-45 kg/m2 * fasting plasma glucose 5.6-6.9 mmol/L, or 2h OGTT plasma glucose 7.8-11.1 mmol/L or haemoglobin A1C 39-46 mmol/mol, homeostasis model assessment-insulin resistance (HOMA-IR) score ≥2.73 * self-reported habitual eating period ≥ 13 h per day
Exclusion criteria
* shift worker * fasting \>12 h/day more than once a week * vegan * \> once a week no food intake after \~1800 h * habitually waking up before \~0400 h and sleeping before \~2100 h * unstable weight (\>5% change the last 2 months) * type 1 or 2 diabetes * sleep disorder (individuals with well-controlled sleep apnoea) * eating disorder * cancer in last 5 years * conditions that render subject unable to complete all testing procedures (including individuals with known allergies or contraindications to the medications used in this study) * use of medications that affect the study outcome measures or increase the risk of study procedures and that cannot be temporarily discontinued (e.g., steroids, alpha- or beta-adrenergic blockers or agonists, etc.) * smoking and illegal drug use * pregnant or lactating * gastrointestinal or bariatric surgery (except cholecystectomy and appendectomy) * unable to grant voluntary informed consent or comply with the study instructions * individuals with electromedical devices * prisoners * alcohol abuse
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood glucose concentration using a YSI analyzer | 3 months (pre-post intervention) | Changes in 24-h area under the curve for blood glucose concentration will be assessed during a 24h metabolic test day. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum insulin concentration using a chemiluminescent assay | 3 months (pre-post intervention) | Changes in s24-h area under the curve for serum insulin concentration will be assessed during a 24h metabolic test day. |
| Serum C-peptide concentration using an ELISA assay | 3 months (pre-post intervention) | Changes in 24-h area under the curve for serum C-peptide concentration will be assessed during a 24h metabolic test day. |
| Plasma FFA concentration using a colorimetric assay | 3 months (pre-post intervention) | Changes in plasma 24-h area under the curve for plasma FFA concentration will be assessed during a 24h metabolic test day. |
| Plasma TG concentration using a colorimetric assay | 3 months (pre-post intervention) | Changes in 24-h area under the curve for plasma TG concentration will be assessed during a 24h metabolic test day. |
| Serum GLP1 concentration using a V-plex assay | 3 months (pre-post intervention) | Changes in 24-h area under the curve for serum GLP1 concentration will be assessed during a 24h metabolic test day. |
| Serum GIP concentration using a V-plex assay | 3 months (pre-post intervention) | Changes in 24-h area under the curve for serum GIP concentration will be assessed during a 24h metabolic test day. |
| Hunger sensation using a standardised questionnaire (visual analog scale) | 3 months (pre-post intervention) | Changes in subjective evaluations hunger during a 24h metabolic test day using standardised visual analog scales of hunger satiety |
Countries
United Kingdom
Contacts
CONTACTMaria Chondronikola
Outcome results
None listed