Extended Evening Fasting: Metabolic Health and Energy Balance

NCT04924517 | Unknown

• 1 other identifier: WM_EEF_2021
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This study will compare metabolic and feeding behaviour responses to 4 days of extended evening fasting vs. a control trial

Conditions

Obesity

Keywords

Chrononutrition; Energy balance; Intermittent fasting; Appetite hormones

Outcome Measures

Primary Outcomes (4)

• Glycaemic control (Baseline)

  A metabolic assessment lasting 3.5 hours will take place following a standardised, laboratory-based meal. The investigators will be taking periodic capillary and venous blood samples to measure post-prandial glucose and insulin, which together comprise 'glycaemic control'.

  3.5 hours following the standardised breakfast meal on day 1.

• Glycaemic control (Post intervention)

  A metabolic assessment lasting 3.5 hours will take place following a standardised, laboratory-based meal. The investigators will be taking periodic capillary and venous blood samples to measure post-prandial glucose and insulin, which together comprise 'glycaemic control'.

  3.5 hours following the standardised breakfast meal on day 4.

• Energy Intake (Kilocalories)

  Energy intake will be measured both during lab and outside of the laboratory when the participants are free-living. During lab, energy intake will be measured through ad-libitum feeding buffet where 20 minutes will be permitted to eat as much or as little as they desire, until 'comfortably full and satisfied', followed by post-feeding measurement of the remaining food. Outside of laboratory feeding will also be monitored through food diary's and weighing any investigator issued meals.

  Day 1 to day 4.

• Energy expenditure

  Energy expenditure will be measured via a chest-worn device (Actiheart) which combines heart rate and accelerometry to gauge calories expended.

  Day 1 to day 4.

Secondary Outcomes (6)

• Cortisol awakening response

  Five samples will be collected by the participant within the first hour of waking on day 5.

• Visual Analogue Scale for Subjective Ratings of Appetite

  Every 2 hours between 8am-10pm from day 1 to day 4.

• Acylated Ghrelin (appetite hormone)

  3.5 hours following the standardised breakfast meal on day 1 and day 4.

• PYY (appetite hormone)

  3.5 hours following the standardised breakfast meal on day 1 and day 4.

• Carbohydrate oxidation

  During laboratory visits on day 1 and day 4 [baseline, 60min, 120min, 180min]

Study Arms (2)

Extended Evening Fasting

EXPERIMENTAL

Participants will eat between 8am-4pm

Behavioral: Extended Evening Fasting

Control

ACTIVE COMPARATOR

Participants will eat between 8am-8pm

Behavioral: Control

Interventions

Extended Evening Fasting BEHAVIORAL

Participants will undertake 4 days of extended evening fasting (feeding between 8am-4pm). The participants will visit the laboratory on day 1, following a 16 h fast, where baseline measures will be taken and the response to a standardised meal will take place. The participant will also have an opportunity to feed ad-libitum before they leave the laboratory. The participant will continue to adhere to the feeding window on day 2 and day 3, although this will be in free-living conditions. On day 4, the participant will arrive back to the lab for post-intervention assessment, identical in format to day 1 with a metabolic assessment and energy intake assessment via a ad-libitum meal.

Extended Evening Fasting

Control BEHAVIORAL

Participants will undertake 4 days of a standard western feeding pattern (feeding between 8am-8pm). The participants will visit the laboratory on day 1, following a 12 h fast, where baseline measures will be taken and the response to a standardised meal will take place. The participant will also have an opportunity to feed ad-libitum before they leave the laboratory. The participant will continue to adhere to the feeding window on day 2 and day 3, although this will be in free-living conditions. On day 4, the participant will arrive back to the lab for post-intervention assessment, identical in format to day 1 with a metabolic assessment and energy intake assessment via a ad-libitum meal.

Control

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Non-smokers.
• Have maintained a stable weight for 6 months (self-reported).
• No history of gastric, digestive, cardiovascular or renal disease (self reported).
• Female specific: must be using a monophasic, low dose combined OCP (containing less than 50μg oestradiol and a synthetic progestin) OR females with regular menstrual cycles (self-reported).

You may not qualify if:

• Severe food allergies, dislike or intolerance of study foods or drinks.
• Currently undergoing a lifestyle intervention (structured diet or exercise)
• Diagnosis of a condition or currently undergoing treatment therapy known to affect glucose or lipid metabolism (e.g., type-2 diabetes, taking statins), or contraindications to exercise.
• Use of medication or supplements that may affect hormone concentrations.
• Excessive alcohol consumption (\>14 units/week).
• Intensive training schedule (\>10 hours/week).
• Female specific: currently pregnant or breastfeeding, the use of any hormonal contraception, and the self-reporting of short (\<24 d), long (\>35 d), or irregular menstrual cycles.

Sponsors & Collaborators

• Nottingham Trent University: lead

Study Sites (1)

Nottingham Trent University

Nottingham, Greater London, NG11 8NS, United Kingdom

RECRUITING

Related Publications (8)

• Sutton EF, Beyl R, Early KS, Cefalu WT, Ravussin E, Peterson CM. Early Time-Restricted Feeding Improves Insulin Sensitivity, Blood Pressure, and Oxidative Stress Even without Weight Loss in Men with Prediabetes. Cell Metab. 2018 Jun 5;27(6):1212-1221.e3. doi: 10.1016/j.cmet.2018.04.010. Epub 2018 May 10.

  PMID: 29754952 BACKGROUND

• Jamshed H, Beyl RA, Della Manna DL, Yang ES, Ravussin E, Peterson CM. Early Time-Restricted Feeding Improves 24-Hour Glucose Levels and Affects Markers of the Circadian Clock, Aging, and Autophagy in Humans. Nutrients. 2019 May 30;11(6):1234. doi: 10.3390/nu11061234.

  PMID: 31151228 BACKGROUND

• Ravussin E, Beyl RA, Poggiogalle E, Hsia DS, Peterson CM. Early Time-Restricted Feeding Reduces Appetite and Increases Fat Oxidation But Does Not Affect Energy Expenditure in Humans. Obesity (Silver Spring). 2019 Aug;27(8):1244-1254. doi: 10.1002/oby.22518.

  PMID: 31339000 BACKGROUND

• Hutchison AT, Regmi P, Manoogian ENC, Fleischer JG, Wittert GA, Panda S, Heilbronn LK. Time-Restricted Feeding Improves Glucose Tolerance in Men at Risk for Type 2 Diabetes: A Randomized Crossover Trial. Obesity (Silver Spring). 2019 May;27(5):724-732. doi: 10.1002/oby.22449. Epub 2019 Apr 19.

  PMID: 31002478 BACKGROUND

• Templeman I, Gonzalez JT, Thompson D, Betts JA. The role of intermittent fasting and meal timing in weight management and metabolic health. Proc Nutr Soc. 2020 Feb;79(1):76-87. doi: 10.1017/S0029665119000636. Epub 2019 Apr 26.

  PMID: 31023390 BACKGROUND

• Popkin BM. The nutrition transition and obesity in the developing world. J Nutr. 2001 Mar;131(3):871S-873S. doi: 10.1093/jn/131.3.871S.

  PMID: 11238777 BACKGROUND

• Allison KC, Goel N. Timing of eating in adults across the weight spectrum: Metabolic factors and potential circadian mechanisms. Physiol Behav. 2018 Aug 1;192:158-166. doi: 10.1016/j.physbeh.2018.02.047. Epub 2018 Feb 24.

  PMID: 29486170 BACKGROUND

• St-Onge MP, Ard J, Baskin ML, Chiuve SE, Johnson HM, Kris-Etherton P, Varady K; American Heart Association Obesity Committee of the Council on Lifestyle and Cardiometabolic Health; Council on Cardiovascular Disease in the Young; Council on Clinical Cardiology; and Stroke Council. Meal Timing and Frequency: Implications for Cardiovascular Disease Prevention: A Scientific Statement From the American Heart Association. Circulation. 2017 Feb 28;135(9):e96-e121. doi: 10.1161/CIR.0000000000000476. Epub 2017 Jan 30.

  PMID: 28137935 BACKGROUND

MeSH Terms

Conditions

Obesity; Intermittent Fasting

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Fasting; Feeding Behavior; Behavior

Central Study Contacts

William Mode, MRes

CONTACT

+447484751219; william_mode@hotmail.co.uk

David Clayton, PhD

CONTACT

(+44) 115 848 5514; David.Clayton@ntu.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: The study design is a randomised, controlled, crossover design in which participants undertake two conditions in a randomised order with at least four weeks in between trials.

Study Record Dates

• First Submitted: May 24, 2021
• First Posted: June 14, 2021
• Study Start: September 14, 2021
• Primary Completion: June 14, 2022
• Study Completion: June 14, 2022
• Last Updated: March 31, 2022

Record last verified: 2022-03

Locations

GB (1)