Acute Metabolic Effects of Carbohydrate Restriction at Varying Energy Levels

Healthy Clinical Trial

Official title:

Investigation Into the Postprandial Effects of Varying Calorie Content of Low-Carbohydrate Diets on Human Metabolic Health

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06387940
• Other study ID #: UEC 2019 008 FHMS
• Status: Completed
• Phase: N/A
• Start date: November 5, 2019
• Est. completion date: November 20, 2022

Study information

• Verified date: April 2024
• Source: University of Surrey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: November 20, 2022
• Est. primary completion date: April 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• nEB Diet, followed for 36 hours
nEB diet first, then LC25 and LCEB in random order with a 5 days washout between each diet
• LC25 Diet, followed for 36 hours
LC25 diet first, then nEB and LCEB in random order with a 5 days washout between each diet
• LCEB Diet, followed for 36 hours
LCEB diet first, then LC25 and nEB in random order with a 5 days washout between each diet

Locations

Country	Name	City	State
United Kingdom	University of Surrey	Guildford

Sponsors (1)

Lead Sponsor	Collaborator
University of Surrey

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biomarkers in blood Measured	Measured with ELISA assay and clinical analyser (INDIKO)	8 hours (fasting and post-meal)
Primary	Resting metabolic rate	Measured with indirect calorimetry (GEM)	8 hours (fasting and post-meal)
Secondary	Perceived Appetite Scores	Measured with a Visual Analog Scale	8 hours (fasting and post-meal)
Secondary	Food intake	Measured using food diaries	baseline and after each diet arm for 1 day