Acute Metabolic Effects of Carbohydrate Restriction at Varying Energy Levels

NCT ID: NCT06387940

Last Updated: 2024-04-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-05
• Study Completion Date: 2022-11-20

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

normal carbohydrate, energy-balanced diet, (nEB)

provided participants' 100% daily energy needs, following the balanced Eatwell Guide recommendations.

Group Type: ACTIVE_COMPARATOR

nEB Diet, followed for 36 hours

Intervention Type: OTHER

nEB diet first, then LC25 and LCEB in random order with a 5 days washout between each diet

low-carbohydrate, energy-balanced diet, (LCEB)

diet contained just 50g of carbohydrates but still met 100% of the participants' estimated daily energy needs.

Group Type: ACTIVE_COMPARATOR

LCEB Diet, followed for 36 hours

Intervention Type: OTHER

LCEB diet first, then LC25 and nEB in random order with a 5 days washout between each diet

low-carbohydrate, energy-restricted diet, (LC25)

The diet consisted of only 50g of carbohydrates and provided 25% of the estimated daily energy needs.

Group Type: ACTIVE_COMPARATOR

LC25 Diet, followed for 36 hours

Intervention Type: OTHER

LC25 diet first, then nEB and LCEB in random order with a 5 days washout between each diet

Interventions

nEB Diet, followed for 36 hours

nEB diet first, then LC25 and LCEB in random order with a 5 days washout between each diet

Intervention Type: OTHER

LC25 Diet, followed for 36 hours

LC25 diet first, then nEB and LCEB in random order with a 5 days washout between each diet

Intervention Type: OTHER

LCEB Diet, followed for 36 hours

LCEB diet first, then LC25 and nEB in random order with a 5 days washout between each diet

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Surrey

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hayriye Biyikoglu

Role: PRINCIPAL_INVESTIGATOR

University of Surrey

Locations

University of Surrey

Guildford, , United Kingdom

Countries

United Kingdom

Other Identifiers

UEC 2019 008 FHMS

Identifier Type: -

Identifier Source: org_study_id