Effects of Two Weeks of 5:2 Intermittent Energy Restriction on Basal and Postprandial Metabolism

NCT04138160 | Completed

• 1 other identifier: 121-1809
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

Worldwide, a third of adults were overweight in 2016, and 13% were obese. Excess energy intake results in weight gain. Excess fat increases the risk of disease (eg. cardiovascular diseases, type 2 diabetes mellitus (T2DM), hypertension, dyslipidemia, dementia, certain cancers). Modest weight reduction (\>5% of body weight) decreases the incidence and progression of many of these diseases. Daily energy restriction or continuous energy restriction (CER) involves diets that have a 500-600 kcal deficit per day resulting in sustainable weight loss. However, adherence is difficult. Diets following a 5:2 intermittent energy restriction (5:2 IER) pattern may be better. Approximately 75% energy restriction is maintained for 2 non-consecutive days/week and normal energy intake is consumed on the remaining 5 days of the week. Significantly reduced fasting insulin concentration and insulin resistance were shown in the 5:2 IER regimen compared with the CER regimen. In this study, normal-weight young participants will be recruited and 5:2 IER and CER will be compared over 2 week periods. Subcutaneous continuous glucose monitoring (CGM) devices will be undertaken. An ad libitum pasta meal will be consumed by participants three hours after the ingestion of breakfast to evaluate the energy intake. Postprandial thermogenesis in response to the test drink will be evaluated.

Conditions

Weight Loss

Keywords

obesity dietary restriction

Outcome Measures

Primary Outcomes (1)

• Incremental area under the curve for insulin

  Incremental area under the curve for serum insulin will be calculated using samples at 20 minute intervals between baseline and three hours.

  Over three hours from baseline

Secondary Outcomes (6)

• Incremental area under the curve for arterialised whole blood glucose

  Over four hours post baseline

• Incremental area under the curve for composite appetite score

  Over four hour from baseline

• Weight of consumption of a pasta meal three hours after baseline

  Three hours post baseline

• Incremental area under the curve for free fatty acid

  Over three hours from baseline

• Incremental area under the curve for TAG

  Over three hours from baseline

Study Arms (2)

5:2 intermittent energy restriction

EXPERIMENTAL

The 5:2 intermittent energy restriction (IER) of 70% restriction (\~600 kcal) delivered for two non-consecutive days/week and no restriction (so sufficient energy to meet the requirement of participants) on the other 5 days/week.

Other: 5:2 Intermittent energy restriction

Continuous energy restriction

OTHER

The continuous energy restriction (CER) of 20% restriction below the estimated requirement of participants (\~1600 kcal) 7 days/week.

Other: Continuous energy restriction

Interventions

5:2 Intermittent energy restriction OTHER

Substantial (70%) energy restriction for 2 non-consecutive days/week interspersed with normal energy intake (isoenergetic) on the remaining 5 days of the week.

Also known as: 5:2 IER

5:2 intermittent energy restriction

Continuous energy restriction OTHER

20% energy restriction each day relative to the energy requirement.

Also known as: CER

Continuous energy restriction

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• ages between 20 - 35 years;
• healthy with a body mass index (BMI) between 20 and 27 kg·m-2;
• a waist circumference \< 94 cm for males and \< 80 cm for females;
• ability to give informed consent

You may not qualify if:

• smoking (including vaping);
• regularly skipping breakfast;
• any metabolic (e.g. diabetes), endocrine (e.g. hyperthyroidism) or cardiovascular (e.g. heart or blood) abnormalities including hypertension or heart failure;
• clinically significant abnormalities on screening including ECG abnormalities;
• taking routine medication that may alter cardiovascular function and blood flow (e.g. blood pressure-lowering drugs or drugs that cause hypertension);
• taking medication for diabetes or having diabetes;
• a history of substance abuse in the last six months;
• well-trained individuals with PAL\>2.00;
• on an energy-restricted diet;
• high alcohol consumption (\<3-4 units/d for men; \<2-3 units/d for women);
• females who are pregnant or lactating and with irregular menstrual cycles;
• self-reported allergy, intolerance or strong dislike of foods or drinks to be offered for the test breakfast, pasta meal or during the intervention period;
• Beck Depression Inventory (BDI) score \>10, and Eating Attitudes Test (EAT-26) score \>20 as self-reported markers of symptoms and concerns characteristic of depression and eating disorders, respectively.

Sponsors & Collaborators

• University of Nottingham: lead

Study Sites (1)

University of Nottingham

Nottingham, Select State..., NG7 2UH, United Kingdom

Location

MeSH Terms

Conditions

Weight Loss

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ian Macdonald, PhD

  University of Nottingham

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2019
• First Posted: October 24, 2019
• Study Start: October 18, 2018
• Primary Completion: May 22, 2019
• Study Completion: May 22, 2019
• Last Updated: November 21, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: When requested.
• Access Criteria: On receipt of requests, data will be made accessible if agreed by both the University of Nottingham.

Locations

GB (1)