NCT07250191

Brief Summary

Most individuals spend the majority of the day in a fed state, making postprandial blood glucose and lipid regulation a central component of metabolic health. Short periods of fasting or reduced carbohydrate intake can occur frequently in daily life, whether through intentional dietary practices (e.g. intermittent fasting), cultural or religious traditions, or unstructured eating patterns. These periods can induce measurable metabolic changes, but the acute effects of a single 24-hour period of fasting or carbohydrate restriction on postprandial metabolism upon refeeding remain poorly characterised. This study will examine how 24 hours of either complete fasting or low carbohydrate intake without energy restriction influence postprandial blood glucose and lipid concentrations, as well as related metabolic markers, in healthy adults, in comparison to a habitual high carbohydrate control diet. Participants will complete all three conditions in a randomised order, consuming a standardised meal test after each 24-hour condition. Repeated blood sampling and gas exchange measurements will be carried out to assess postprandial metabolic responses. The aim of this study is to characterise whether acute periods of fasting and low carbohydrate restriction elicit distinct or comparable alterations in postprandial metabolic responses. A clearer understanding of these acute physiological effects can help inform how variations in eating patterns influence glucose and lipid handling in individuals without metabolic disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2023

Typical duration for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 16, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2024

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 6, 2025

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

November 18, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 26, 2025

Completed
Last Updated

November 26, 2025

Status Verified

November 1, 2025

Enrollment Period

3 months

First QC Date

November 18, 2025

Last Update Submit

November 18, 2025

Conditions

Keywords

carbohydrate restrictionfastingintermittent energy restriction

Outcome Measures

Primary Outcomes (2)

  • Triglyceride Concentration

    Plasma triglyceride concentrations assessed at baseline and postprandially for 2 hours after a mixed meal test

    After each 24-hour dietary condition

  • Glucose Concentration

    Plasma glucose concentrations assessed at baseline and postprandially for 2 hours after a mixed meal test

    After each 24-hour dietary condition

Secondary Outcomes (4)

  • Insulin Concentration

    After each 24-hour dietary condition

  • Non-esterified Fatty Acid Concentration

    After each 24-hour dietary condition

  • Beta-hydroxybutyrate Concentration

    After each 24-hour dietary condition

  • Substrate Oxidation

    After each 24-hour dietary condition

Study Arms (3)

Habital control diet

NO INTERVENTION

100% of energy requirements, ≥150 carbohydrate/day

Fasting

EXPERIMENTAL

No energy intake

Behavioral: Fasting

Carbohydrate Restriction

EXPERIMENTAL

100% of energy requirements, ≤20g carbohydrate

Behavioral: Carbohydrate restriction

Interventions

FastingBEHAVIORAL

No food intake for 24 hours

Fasting

Restriction of dietary carbohydrate to ≤5% of total energy intake for 24 hours

Also known as: Ketogenic diet
Carbohydrate Restriction

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Aged between 18-40 years
  • Have a BMI of 18.5-29.9 kg/m2

You may not qualify if:

  • Diagnosed with any major chronic conditions (e.g. type 2 diabetes, coronary heart disease, cancer, chronic kidney disease, etc.)
  • Use of medication that may interfere with study outcomes (e.g. glucose or lipid-lowering medications)
  • Currently or recently pregnant (within last 6 months), planning to get pregnant or currently lactating
  • Has a habitually low carbohydrate intake (\<150g carbohydrates/day)
  • Current or previous eating disorder
  • Has donated more than 500ml of blood in the last 3 months prior to the initial laboratory visit
  • Insufficient mental capacity or language skills to independently understand and follow the study protocol
  • Has an irregular sleeping pattern (e.g. due to undertaking night-shift work)
  • Any other condition, concurrent intervention or behaviour deemed either to pose undue personal risk to the participant or to introduce bias into the experiment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Bath

Bath, BA2 7AY, United Kingdom

Location

MeSH Terms

Conditions

Fasting

Interventions

Angptl4 protein, mouseDiet, Ketogenic

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Intervention Hierarchy (Ancestors)

Diet, Carbohydrate-RestrictedDiet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctoral Researcher

Study Record Dates

First Submitted

November 18, 2025

First Posted

November 26, 2025

Study Start

October 16, 2023

Primary Completion

January 20, 2024

Study Completion

November 6, 2025

Last Updated

November 26, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations