CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 4 enrolled
Drug / intervention
Regular meal pattern +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05569837
NCT05569837N/ACompleted

The Effect of Irregular Meal Pattern Providing Hypo-energetic Diet on Energy Expenditure, Metabolism and Circadian Rhythm: a Randomized Controlled Trial

University of Nottingham·interventional·Posted Oct 6, 2022·Updated Nov 2, 2022

In Brief

A clinical study evaluating Regular meal pattern and Irregular meal pattern for Metabolic Disturbance and Obesity. Completed, enrolled 4 participants across 1 site.

Detailed Summary

In this study we will compare the effect of two different meal patterns. Firstly, participants will consume a diet providing their estimated energy requirement for a 7 day standardisation period (6 meals per day). After a one day laboratory visit, this will be followed by a 14 day intervention period when participants will randomly follow a regular meal pattern (6 meals/d) or an irregular meal pattern (3-9 meals/d). Following a further laboratory visit day, they will then consume the previous standardisation diet for a further 3 days. The energy intake provided will be calculated to provide less energy than subjects are using which may result in approximately 2kg of weight loss. Participants will attend a screening visit in which they will complete questionnaires on medical health, eating habits and physical activity. In the laboratory visit, participants will be fasting and for 3 h after intake of a test drink, measurements will be taken of energy expenditure, fasting glucose, fasting gut hormones, fasting lipids and fasting insulin. A test meal will be offered. A questionnaire of subjective appetite ratings will be assessed while fasting, after the test drink, after the test meal, and during the intervention. Continuous interstitial glucose monitoring will be undertaken during the whole study period, Core body temperature will be measured before and after the intervention period. Also, wrist temperature will be measured during the whole study period.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited Kingdom
Collaborators--

Timeline

N/ACompletedFinished
20222023202420252026
First PostedOct 6, 2022
Enrollment StartDec 15, 2021
Primary CompletionSep 30, 2022
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 3.7 years ago

Interventions

Regular meal patternother

6 meals every day

Irregular meal patternother

It consists of consuming a different number of meals every day (between 3 and 9).