Acute Metabolic Effects of Carbohydrate Restriction at Varying Energy Levels

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Other: nEB Diet, followed for 36 hours; Other: LCEB Diet, followed for 36 hours; Other: LC25 Diet, followed for 36 hours

• Registration Number: NCT06387940
• Lead Sponsor: University of Surrey

Brief Summary

This study investigates how different low-carbohydrate diets affect metabolism and hunger in overweight adults. We will measure metabolic rates and blood metabolites.

Detailed Description

Participants will engage in three distinct eating plans: a standard diet with usual carbohydrate and calorie levels, a low-carb diet with typical calories, and a low-carb diet with reduced calories. Each diet is followed for a single day, with subsequent monitoring to assess how the body processes food and manages hunger after a meal. The goal is to understand the potential metabolic benefits of reducing carbohydrate intake, either alone or in combination with calorie reduction. This research aims to identify simpler dietary strategies that could improve heart health and assist in weight management without the need for severe calorie restriction or fasting, offering valuable insights for enhancing health outcomes in overweight individuals.

Study Timeline

• Study Start: 2019-11-05
• Primary Completion: 2020-04-01
• Study Completion: 2022-11-20
• Status Verified: 2024-04
• Study First Submitted: 2024-04-17
• Study First Submitted QC: 2024-04-23
• Last Update Submitted: 2024-04-23
• Study First Posted: 2024-04-29
• Last Update Posted: 2024-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• stable weight within ±3 kg over the past three months
• no significant medical history.

Exclusion Criteria

• pregnancy
• breastfeeding,
• using medications that could affect the study's outcomes
• high intake of caffeine and alcohol
• existing eating or psychiatric disorders
• adherence to strict dietary regimens like veganism
• high BMI resulting from significant muscle mass

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
normal carbohydrate, energy-balanced diet, (nEB)	nEB Diet, followed for 36 hours	provided participants' 100% daily energy needs, following the balanced Eatwell Guide recommendations.
low-carbohydrate, energy-balanced diet, (LCEB)	LCEB Diet, followed for 36 hours	diet contained just 50g of carbohydrates but still met 100% of the participants' estimated daily energy needs.
low-carbohydrate, energy-restricted diet, (LC25)	LC25 Diet, followed for 36 hours	The diet consisted of only 50g of carbohydrates and provided 25% of the estimated daily energy needs.

Primary Outcome Measures

Name	Time	Method
Biomarkers in blood Measured	8 hours (fasting and post-meal)	Measured with ELISA assay and clinical analyser (INDIKO)
Resting metabolic rate	8 hours (fasting and post-meal)	Measured with indirect calorimetry (GEM)

Secondary Outcome Measures

Name	Time	Method
Perceived Appetite Scores	8 hours (fasting and post-meal)	Measured with a Visual Analog Scale
Food intake	baseline and after each diet arm for 1 day	Measured using food diaries

Trial Locations

Locations (1)

University of Surrey; 🇬🇧 Guildford, United Kingdom