NCT07805291

Brief Summary

Obesity is one of the largest worldwide health problems. There are increasing rates of overweight and obesity, and in recent years, worldwide the percentage of overweight and obesity among adults now exceeds 1.9 billion and 650 million, respectively. Overweight and obesity are associated with an increase risk of type 2 diabetes (T2D), coronary heart disease, hypertension and other non-communicable diseases. There are multiple nutritional causes for obesity, including both the type and amount of food consumed. Other non-nutritional factors can be just as important to influence body mass, such as the number of meals eaten, which is termed meal frequency. The changing food environment influences calorie consumption, such as increased food variety, increased availability and food processing, a nocturnal lifestyle that disrupts the circadian clock, meal timing and frequency, irregular meal patterns, and prolonged duration of eating during the day. This results in increased food and beverage consumption throughout the day. Meal frequency is commonly defined as, 'the number of foods or drinks a person consumes in one day. Meals and snacks are less clearly defined. Meal is defined as any food providing≥ 50 kcal and separated by more than one hour. In most cultures, the name meal is given to the three eating episodes in a day: breakfast, lunch, and dinner; or breakfast, brunch, lunch, supper, and dinner. In this study, the investigators will use the definition of "breakfast, brunch, lunch, supper, and dinner", but it will be on restricted time: 10 hours eating and 14 hours fasting (from 7:00 to 17:00) and one type of diet (high protein diet). Other researchers have defined meals by the time of the day, such as early and late breakfast, lunch and dinner intake. These definitions differ according to culture. Other researchers have defined meals based on timing, such as (6:00 am -10:00 am), (12:00 pm - 3:00 pm), and (6:00 pm - 9:00 pm). Some studies have highlighted that there are factors that affect the number of meals which a person consumes. Eating a high amount of energy during breakfast helps to feel full for a longer period. Time of eating and duration of eating or not eating. The type of macronutrient intake; for example, high protein (HP) intake reduces ad libitum energy intake. The number of meals eaten per day; some studies have confirmed that consuming small frequent meals is better for healthy weight and appetite control in the general population, compared to consuming one huge meal a day. This can assist control of appetite and plasma glucose concentrations. On the other hand, recent research has indicated that consuming (≥6 meals/day) increases disease risk significantly more than consuming (1-2 meals/day). Some researchers believe that there is no relationship between meal frequency and body weight.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Sep 2024

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 12, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 14, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2025

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 20, 2026

Completed
4 months until next milestone

First Posted

Study publicly available on registry

September 4, 2026

Completed
Last Updated

September 4, 2026

Status Verified

February 1, 2025

Enrollment Period

7 months

First QC Date

May 20, 2026

Last Update Submit

September 2, 2026

Conditions

Keywords

ObesityMeal FrequencyAppetiteBody CompositionGlycaemic ResponseTime-restricted Eating

Outcome Measures

Primary Outcomes (1)

  • The participant's appetite response on the test day (day 3rd, 7th, 17th, and 21st)

    Measured with visual analogue scales (VAS).

    On test days recorded at timepoints 0, 30, 60, 90, 120, 150 and 180 minutes. On all study days recorded hourly during waking hours. The straight line is 100 mm long, left side indicates low symptoms.

Secondary Outcomes (14)

  • Plasma blood glucose on the test day (day 3rd, 7th, 17th, and 21st)

    The blood samples will be collected by multiple venepuncture before breakfast (T0 minutes) and post prandial (T180 minutes).

  • Plasma blood insulin on the test day (day 3rd, 7th, 17th, and 21st)

    The blood samples will be collected by multiple venepuncture before breakfast (T0 minutes) and post prandial (T180 minutes).

  • Continuous glucose monitoring System (CGMS)

    Day 1-7 and day 15-21 which correspond to weight loss diet periods.

  • Resting Metabolic Rate (RMR) on test day (day 3rd, 7th, 17th, and 21st)

    Resting metabolic rate (RMR, 30 minutes before eating breakfast) on screening visit and Test Day (3, 7, 17, and 21).

  • Thermic Effect of Food (TEF ) on test day (day 3rd, 7th, 17th, and 21st)

    Thermic effect of food (TEF post prandial 180 minutes, measured 10 minutes, every 30 minutes by ventilated hood; at 30, 60, 90, 10, 150, and 180 minutes) on Test Day 3, 7, 17, and 21.

  • +9 more secondary outcomes

Study Arms (2)

weight loss diet 1 (2MPD)

EXPERIMENTAL

Intervention weight loss diet 1 (2MPD, 2 meals/day) for 4 days

Other: MT1Other: MT2

weight loss diet2 (5MPD)

EXPERIMENTAL

Intervention weight loss diet 2 (5MPD, 5 meals/day) for 4 days

Other: MT1Other: MT2

Interventions

MT1OTHER

\- On days 1-2 (MT1) 15:30:55% of energy from protein, fat and carbohydrate respectively).

weight loss diet 1 (2MPD)weight loss diet2 (5MPD)
MT2OTHER

\- On days 16-17 (MT2) 15:30:55% of energy from protein, fat and carbohydrate respectively).

weight loss diet 1 (2MPD)weight loss diet2 (5MPD)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults (males and females), age 18-65 years
  • Who are healthy but overweight or obese (BMI 25+ Kg/m2)
  • With no history of kidney disease or bariatric surgery
  • Not following any specific type of medical or religious diet
  • Not taking any drugs that affect the rate of physical activity or metabolic circulating
  • Not pregnant or breastfeeding.
  • With a fluent understanding of the English language

You may not qualify if:

  • Anyone with a BMI (in kg/m2) under 25
  • Anyone under 18 years or above 65 years.
  • Anyone taking the statins (current), aspirin or anti-coagulants (current).
  • Anyone with chronic inflammatory disorders such as rheumatoid arthritis or inflammatory bowel disease
  • Anyone with cardiovascular disease
  • Anyone with diabetes
  • Anyone who is are planning to be pregnant, are pregnant or breastfeeding
  • Anyone with food allergy, self-reported food sensitivity or intolerance
  • Anyone with coeliac disease or gluten intolerance
  • Anyone with a gastrointestinal disorder, kidney disease, liver disease or gout
  • Anyone taking medication which may affect appetite or circadian rhythm.
  • Anyone with an eating disorder
  • Anyone suffering from unregulated thyroid disease.
  • Anyone using Beta Blockers which can affect the rate of physical activity.
  • Anyone using some anti-depressants such as mirtazapine can affect the appetite.
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Aberdeen, The Rowett Institute, Foresterhill

Aberdeen, Aberdeen City, AB25 2ZD, United Kingdom

Location

Related Publications (30)

  • 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: 31339000BACKGROUND
  • St-Onge MP, Pizinger T, Kovtun K, RoyChoudhury A. Sleep and meal timing influence food intake and its hormonal regulation in healthy adults with overweight/obesity. Eur J Clin Nutr. 2019 Jul;72(Suppl 1):76-82. doi: 10.1038/s41430-018-0312-x.

    PMID: 30487565BACKGROUND
  • Ruddick-Collins LC, Flanagan A, Johnston JD, Morgan PJ, Johnstone AM. Circadian Rhythms in Resting Metabolic Rate Account for Apparent Daily Rhythms in the Thermic Effect of Food. J Clin Endocrinol Metab. 2022 Jan 18;107(2):e708-e715. doi: 10.1210/clinem/dgab654.

    PMID: 34473293BACKGROUND
  • Perrigue MM, Drewnowski A, Wang CY, Neuhouser ML. Higher Eating Frequency Does Not Decrease Appetite in Healthy Adults. J Nutr. 2016 Jan;146(1):59-64. doi: 10.3945/jn.115.216978. Epub 2015 Nov 11.

    PMID: 26561409BACKGROUND
  • Onder G, Marengoni A, Russo P, Degli Esposti L, Fini M, Monaco A, Bonassi S, Palmer K, Marrocco W, Pozzi G, Sangiorgi D, Buda S, Marchionni N, Mammarella F, Bernabei R, Pani L, Pecorelli S; Geriatrics Working Group of the Italian Medicines Agency (Agenzia Italiana del Farmaco, AIFA); Medicines Utilization Monitoring Center Health Database Network. Advanced Age and Medication Prescription: More Years, Less Medications? A Nationwide Report From the Italian Medicines Agency. J Am Med Dir Assoc. 2016 Feb;17(2):168-72. doi: 10.1016/j.jamda.2015.08.009.

    PMID: 26441359BACKGROUND
  • Chen YF, Dewey ME, Avery AJ; Analysis Group of The MRCCFA Study. The Medical Research Council Cognitive Function and Ageing Study (MRC CFAS). Self-reported medication use for older people in England and Wales. J Clin Pharm Ther. 2001 Apr;26(2):129-40. doi: 10.1046/j.1365-2710.2001.00333.x.

    PMID: 11350536BACKGROUND
  • O'Connor SG, Reedy J, Graubard BI, Kant AK, Czajkowski SM, Berrigan D. Circadian timing of eating and BMI among adults in the American Time Use Survey. Int J Obes (Lond). 2022 Feb;46(2):287-296. doi: 10.1038/s41366-021-00983-3. Epub 2021 Oct 20.

    PMID: 34671108BACKGROUND
  • Hampl JS, Heaton CL, Taylor CA. Snacking patterns influence energy and nutrient intakes but not body mass index. J Hum Nutr Diet. 2003 Feb;16(1):3-11. doi: 10.1046/j.1365-277x.2003.00417.x.

    PMID: 12581404BACKGROUND
  • Oyeyemi AL, Moss SJ, Monyeki MA, Kruger HS. Measurement of physical activity in urban and rural South African adults: a comparison of two self-report methods. BMC Public Health. 2016 Sep 22;16(1):1004. doi: 10.1186/s12889-016-3693-6.

    PMID: 27658580BACKGROUND
  • Smeets AJ, Westerterp-Plantenga MS. Acute effects on metabolism and appetite profile of one meal difference in the lower range of meal frequency. Br J Nutr. 2008 Jun;99(6):1316-21. doi: 10.1017/S0007114507877646. Epub 2007 Dec 6.

    PMID: 18053311BACKGROUND
  • Anderson GH, Catherine NL, Woodend DM, Wolever TM. Inverse association between the effect of carbohydrates on blood glucose and subsequent short-term food intake in young men. Am J Clin Nutr. 2002 Nov;76(5):1023-30. doi: 10.1093/ajcn/76.5.1023.

    PMID: 12399274BACKGROUND
  • Alhussain MH, Macdonald IA, Taylor MA. Impact of isoenergetic intake of irregular meal patterns on thermogenesis, glucose metabolism, and appetite: a randomized controlled trial. Am J Clin Nutr. 2022 Jan 11;115(1):284-297. doi: 10.1093/ajcn/nqab323.

    PMID: 34555151BACKGROUND
  • Ohkawara K, Cornier MA, Kohrt WM, Melanson EL. Effects of increased meal frequency on fat oxidation and perceived hunger. Obesity (Silver Spring). 2013 Feb;21(2):336-43. doi: 10.1002/oby.20032.

    PMID: 23404961BACKGROUND
  • Speechly DP, Buffenstein R. Greater appetite control associated with an increased frequency of eating in lean males. Appetite. 1999 Dec;33(3):285-97. doi: 10.1006/appe.1999.0265.

    PMID: 10625522BACKGROUND
  • Speechly DP, Rogers GG, Buffenstein R. Acute appetite reduction associated with an increased frequency of eating in obese males. Int J Obes Relat Metab Disord. 1999 Nov;23(11):1151-9. doi: 10.1038/sj.ijo.0801046.

    PMID: 10578205BACKGROUND
  • Correia JM, Santos I, Pezarat-Correia P, Minderico C, Mendonca GV. Effects of Intermittent Fasting on Specific Exercise Performance Outcomes: A Systematic Review Including Meta-Analysis. Nutrients. 2020 May 12;12(5):1390. doi: 10.3390/nu12051390.

    PMID: 32408718BACKGROUND
  • Jones R, Pabla P, Mallinson J, Nixon A, Taylor T, Bennett A, Tsintzas K. Two weeks of early time-restricted feeding (eTRF) improves skeletal muscle insulin and anabolic sensitivity in healthy men. Am J Clin Nutr. 2020 Oct 1;112(4):1015-1028. doi: 10.1093/ajcn/nqaa192.

    PMID: 32729615BACKGROUND
  • Paoli A, Tinsley G, Bianco A, Moro T. The Influence of Meal Frequency and Timing on Health in Humans: The Role of Fasting. Nutrients. 2019 Mar 28;11(4):719. doi: 10.3390/nu11040719.

    PMID: 30925707BACKGROUND
  • Leech RM, Worsley A, Timperio A, McNaughton SA. Understanding meal patterns: definitions, methodology and impact on nutrient intake and diet quality. Nutr Res Rev. 2015 Jun;28(1):1-21. doi: 10.1017/S0954422414000262. Epub 2015 Mar 19.

    PMID: 25790334BACKGROUND
  • Garaulet M, Gomez-Abellan P, Alburquerque-Bejar JJ, Lee YC, Ordovas JM, Scheer FA. Timing of food intake predicts weight loss effectiveness. Int J Obes (Lond). 2013 Apr;37(4):604-11. doi: 10.1038/ijo.2012.229. Epub 2013 Jan 29.

    PMID: 23357955BACKGROUND
  • Murakami K, Livingstone MB. Associations between Meal and Snack Frequency and Diet Quality in US Adults: National Health and Nutrition Examination Survey 2003-2012. J Acad Nutr Diet. 2016 Jul;116(7):1101-13. doi: 10.1016/j.jand.2015.12.012. Epub 2016 Feb 2.

    PMID: 26847912BACKGROUND
  • Berg C, Forslund HB. The Influence of Portion Size and Timing of Meals on Weight Balance and Obesity. Curr Obes Rep. 2015 Mar;4(1):11-8. doi: 10.1007/s13679-015-0138-y.

    PMID: 26627086BACKGROUND
  • Bachman JL, Phelan S, Wing RR, Raynor HA. Eating frequency is higher in weight loss maintainers and normal-weight individuals than in overweight individuals. J Am Diet Assoc. 2011 Nov;111(11):1730-4. doi: 10.1016/j.jada.2011.08.006.

    PMID: 22027056BACKGROUND
  • Zimmerman AR, Johnson L, Brunstrom JM. Assessing "chaotic eating" using self-report and the UK Adult National Diet and Nutrition Survey: No association between BMI and variability in meal or snack timings. Physiol Behav. 2018 Aug 1;192:64-71. doi: 10.1016/j.physbeh.2018.03.024. Epub 2018 Mar 24.

    PMID: 29580954BACKGROUND
  • Ha K, Song Y. Associations of Meal Timing and Frequency with Obesity and Metabolic Syndrome among Korean Adults. Nutrients. 2019 Oct 13;11(10):2437. doi: 10.3390/nu11102437.

    PMID: 31614924BACKGROUND
  • Flanagan A, Bechtold DA, Pot GK, Johnston JD. Chrono-nutrition: From molecular and neuronal mechanisms to human epidemiology and timed feeding patterns. J Neurochem. 2021 Apr;157(1):53-72. doi: 10.1111/jnc.15246. Epub 2020 Dec 10.

    PMID: 33222161BACKGROUND
  • Zeron-Rugerio MF, Diez-Noguera A, Izquierdo-Pulido M, Cambras T. Higher eating frequency is associated with lower adiposity and robust circadian rhythms: a cross-sectional study. Am J Clin Nutr. 2021 Jan 4;113(1):17-27. doi: 10.1093/ajcn/nqaa282.

    PMID: 33094802BACKGROUND
  • Sjöholm, M., 2017. Does eating frequency correlate with overweight and obesity among Swedish men and women?

    BACKGROUND
  • Sharma, Sarit, Sharma, Sumita, 2020. Obesity epidemic: Striking the younger age group. Med. J. Dr Patil Vidyapeeth 13, 333. https://doi.org/10.4103/mjdrdypu.mjdrdypu_307_19

    BACKGROUND
  • Windisch, L., Andrade, J., 2017. The Effects a Traditional Meal Pattern vs. Small Frequent Meals has on Body Composition in Overweight and Obese Adults: A Systematic Review 1, 8.

    BACKGROUND

MeSH Terms

Conditions

ObesityIntermittent Fasting

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsFastingFeeding BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Model Details: Within subject design
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2026

First Posted

September 4, 2026

Study Start

September 12, 2024

Primary Completion

April 14, 2025

Study Completion

August 31, 2025

Last Updated

September 4, 2026

Record last verified: 2025-02

Locations