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Completed

NCT Number: NCT06387940

Acute Metabolic Effects of Carbohydrate Restriction at Varying Energy Levels

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

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Key information

Conditions

Healthy

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Surrey

Guildford, GU2 7XH, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

nEB Diet, followed for 36 hours

Other

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

LC25 Diet, followed for 36 hours

Other

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

LCEB Diet, followed for 36 hours

Other

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

Primary outcomes

  1. Biomarkers in blood Measured

    Time frame: 8 hours (fasting and post-meal)

    Measured with ELISA assay and clinical analyser (INDIKO)

  2. Resting metabolic rate

    Time frame: 8 hours (fasting and post-meal)

    Measured with indirect calorimetry (GEM)

Secondary outcomes

  1. Perceived Appetite Scores

    Time frame: 8 hours (fasting and post-meal)

    Measured with a Visual Analog Scale

  2. Food intake

    Time frame: baseline and after each diet arm for 1 day

    Measured using food diaries

Sponsors and collaborators

Lead sponsor

University of Surrey

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2022
First posted
Apr 29, 2024
Registry last updated
Apr 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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