Obesity Prevention Clinical Trial
Official title:
The Effect of Acute Time-Restricted Eating on Energy Intake, Subjective Appetite and Glycaemic Control in Young Healthy Males
Verified date | March 2022 |
Source | Nottingham Trent University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study compared the metabolic response to three different eating windows (morning fast,12pm-8pm; evening fast, 8am-4pm; control, 8am-8pm).
Status | Completed |
Enrollment | 18 |
Est. completion date | December 13, 2019 |
Est. primary completion date | December 13, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 30 Years |
Eligibility | Inclusion Criteria: - recreationally active - non-smokers - non-dieting - weight stable (self-reported for >6 months) - were not consuming any medication known to affect appetite or physical activity Exclusion Criteria: - Smokers - >10 hours per week physical activity - Have dieted within the past 6 months - Excessive alcohol consumption (>14 units/week) - Use of medication or supplements that may affect hormone concentrations. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Nottingham Trent University | Nottingham | Nottinghamshire |
Lead Sponsor | Collaborator |
---|---|
Nottingham Trent University | Loughborough University |
United Kingdom,
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. Review. — View Citation
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. do — View Citation
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). pii: E1234. doi: — View Citation
Popkin BM. The nutrition transition and obesity in the developing world. J Nutr. 2001 Mar;131(3):871S-873S. Review. — View Citation
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.2251 — View Citation
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 Cardio — View Citation
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. — View Citation
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. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Glycaemic Control | 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'. | 0 hour (Pre breakfast), 1 hour, 2 hour, 3.5 hour | |
Secondary | Energy Intake | 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. | 3.5 hour following breakfast | |
Secondary | Energy expenditure | Energy expenditure will be measured via a chest-worn device (Actiheart) which combines heart rate and accelerometry to gauge calories expended. | Activity recorded across day 1 standardisation and day 2 (lab visit and post lab visit) | |
Secondary | Visual analogue scale for subjective ratings of appetite | Subjective appetite will be measured on mobile devices via a software which replicates a 100mm visual analogue scale. The scale is divided into subscales of different appetite perceptions including: hunger, fullness, desire to eat and prospective food consumption. This will be measured on a scale of 0-100 (0 - none at all) (100 - a lot). | 0 hour (pre-breakfast), 1 hour, 2 hour, 3 hour, 4 hour (post breakfast during lab visit) | |
Secondary | Acylated Ghrelin (Appetite hormone) | Acylated Ghrelin will be measured from the venous samples taken during the post-prandial period following the standardised meal. | 0 hour (pre breakfast), 1 hour, 2 hour, and 3 hour post breakfast | |
Secondary | PYY (Appetite hormone) | Acylated Ghrelin will be measured from the venous samples taken during the post-prandial period following the standardised meal. | 0 hour (pre-breakfast), 1 hour, 2 hour, and 3 hour post breakfast | |
Secondary | Carbohydrate Oxidation | Investigators will be collecting expired air into Douglas bags, and measuring the VO2 and VCO2 concentration to calculate carbohydrate oxidation. | 0 hour (pre breakfast), 1 hour, 2 hour, 3 hour post breakfast | |
Secondary | Fat Oxidation | Investigators will be collecting expired air into Douglas bags, and measuring the VO2 and VCO2 concentration to calculate fat oxidation. | 0 hour (pre breakfast), 1 hour, 2 hour, 3 hour |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02147496 -
Fluid Dairy Products Consumed Before and Within a Pizza Meal on Glycemic Response, Food Intake and Satiety in Children
|
Phase 1/Phase 2 | |
Completed |
NCT01025557 -
Isovolumetric and Isocaloric Preloads of Various Types of Milk on Food Intake, Subjective Appetite and Glycemic Response
|
Phase 1/Phase 2 | |
Completed |
NCT00593749 -
Healthy Corner Store Initiative
|
N/A | |
Completed |
NCT03850821 -
Social Mechanisms for Promoting Physical Activity in After School Programs for Underserved Middle School Youth
|
N/A | |
Completed |
NCT02385890 -
PERFECT Project - Part 1 - Study 3
|
N/A | |
Completed |
NCT02365363 -
PERFECT Project - Part 2 - Study 3
|
N/A | |
Completed |
NCT01042418 -
Appetite Profile After Intake of Rye Breakfast Meal
|
N/A | |
Completed |
NCT01196351 -
Activity at Ventilation Threshold on Appetite and Food Intake in Boys
|
N/A | |
Completed |
NCT01206413 -
A Randomized Clinical Trial of Home-based Exercise Combined With a Slight Caloric Restriction on Obesity Prevention Among Women
|
Phase 4 | |
Completed |
NCT01996514 -
Food Advertisements, Satiety and Food Intake in Children
|
N/A | |
Completed |
NCT02370927 -
PERFECT Project - Part 2 - Study 2
|
N/A | |
Completed |
NCT02366598 -
A FINEH Protein Trial - Part 1
|
N/A | |
Completed |
NCT00988377 -
The Effect of Whey Protein on Short-Term Food Intake and Post-Meal Blood Glucose Response in Young Men
|
N/A | |
Completed |
NCT02366572 -
PERFECT Project - Part 1 - Study 2
|
N/A | |
Completed |
NCT02402504 -
PERFECT Project - Part 1 - Study 1
|
N/A | |
Active, not recruiting |
NCT01117363 -
Effect of Three Weeks Consumption of Rye Porridge Breakfast
|
N/A | |
Completed |
NCT00456911 -
Family Dietary Coaching to Improve Nutritional Intakes and Body Weight Control
|
N/A | |
Completed |
NCT04445740 -
The i Heart Rhythm Project: Healthy Sleep and Behavioral Rhythms for Obesity Prevention
|
N/A | |
Completed |
NCT00988689 -
Types of Starch and Their Effect on Blood Glucose, Appetite and Food Intake
|
N/A | |
Completed |
NCT02458027 -
Acute Food INtake Effect of Hemp Protein (A FINEH Protein) Trial - Part 2
|
N/A |