Low-carbohydrate Diet and Low-Density Lipoprotein - Cholesterol (LDL-c) Interindividual Variability (REPETO)
2026년 6월 25일 업데이트: Bruno Spellanzon, University of Bath
Exploring True Interindividual Heterogeneity of Cardiovascular Disease (CVD) Risk Factors in Response to Low-carbohydrate Diets Using a Replicate Crossover Randomised Controlled Trial
Ketogenic diets are very low-carbohydrate diets that increase hepatic production of ketone bodies, which have several effects as substrates and signals.
Ketogenic diets are used to manage some conditions (e.g., drug-resistant epilepsy), and their potential for managing many other conditions (e.g., cancer) is being actively explored.
Indeed, the British Dietetic Association acknowledge the potential for ketogenic diets to improve glycaemic control to a greater extent than some other diets in people with type 2 diabetes.
A lower fasting glucose is also relevant to future mortality in people without diabetes.
Ketogenic diets are popular in the general population, with up to 15% of the UK following a low-carbohydrate diet.
There is, therefore, great interest in ketogenic diets amongst people with and without health conditions.
However, although the diet shows promising results in improving blood sugar levels, it has also shown to increase low-density lipoprotein-cholesterol (LDL-c) in some individuals, which has been linked to increased cardiovascular health risks.
The aim of this project is to find the potential for personalised use of (or guidance to avoid) ketogenic diets for cardiovascular disease risk.
To do that the investigators will ask participants to replicate 24 hours of a ketogenic diet and a control diet thrice each.
This will allow the investigators to find variability between responses and have a better idea of individuals who could benefit (or not) from following the ketogenic diet.
연구 개요
상세 설명
The study will be a controlled feeding replicate randomised controled trial with 3 cycles, each involving the pair of diets [low carbohydrate (K) and control (C) diets]. There will be 6 x 1-day periods (3 days low carbohydrate and 3 days control). Twenty individuals (body mass index: 18.5-35 kg/m2) will be recruited and randomised into one of the 8 possible sequences:
- KC KC KC
- KC KC CK
- KC CK KC
- KC CK CK
- CK CK CK
- CK CK KC
- CK KC CK
- CK KC KC A week before the interventions start, participants will visit the laboratory so that the investigators can perform indirect calorimetry and collect a blood sample for genotyping. During the week before the interventions, participants will wear activity monitors to determine habitual physical activity. Before each visit, participants will be asked to come to the lab in a rested and overnight fasted state. During the first trial visit, participants will have a dual-energy X-ray absorptiometry (DEXA) body scan to determine body composition. During all 12 study visits the investigators will perform a venepuncture in an antecubital vein and will collect 20 mL of blood.
Additionally, the investigators will also collect urine samples. After odd visits (1st, 3rd, 5th, 7th, 9th and 11th), participants will be supplied with their respective meals for the day (low carbohydrate or control) and will be asked to not eat anything else during the day.
Finally there will be a wash-out period of 6 days between laboratory visits. To keep consistency between trial days, participants will be asked to replicate physical activity levels performed during the 24 hours before the first trial, and during diet day (before second visit), so that these can be replicated for the following visits.
연구 유형
중재적
등록 (추정된)
20
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Bruno Spellanzon, PhD candidate
- 전화번호: 447769407954
- 이메일: bs954@bath.ac.uk
연구 장소
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Bath and North East Somerset
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Bath, Bath and North East Somerset, 영국, BA2 7AY
- 모병
- University of Bath
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수석 연구원:
- Javier Gonzalez, PhD
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연락하다:
- Bruno Spellanzon, PhD candidate
- 전화번호: 447769407954
- 이메일: bs954@bath.ac.uk
-
연락하다:
- Javier Gonzalez, PhD
- 이메일: jg833@bath.ac.uk
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-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
예
설명
Inclusion Criteria:
- Age: >18 years
- Body mass index: 18.5-35 kg·m-2
- Low-Density Lipoprotein-cholesterol <4.9 mmol/L
- Non-fasting triglycerides <2.3 mmol/L
Exclusion Criteria:
- weight instability (>5% change in body mass within last 3 months)
- smoker
- diagnosis of hypercholesterolaemia or any other lipid-related disease
- diagnosis of diabetes
- diagnosis of atherosclerotic cardiovascular disease
- elevated fasting glucose (>5.4 mmol/L)
- dietary intolerances or allergies or to other study procedures
- diagnosis of gastrointestinal disorders
- any other condition/medication that could introduce bias to the study
- already following a ketogenic diet
- not willing to follow a ketogenic diet
- unable to understand English language
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
다른: Sequence 1
Participants will follow a 1) low-carbohydrate diet, wash-out, 2) control diet, wash-out, 3) low-carbohydrate diet, wash-out, 4) control diet, wash-out, 5) low-carbohydrate diet, wash-out, 6) control diet
|
Diet will have macronutrients split with 50% carbohydrates, 15% protein and 35% fat.
Also there will be a 0.66 ratio saturated:unsaturated fat
Diet will have macronutrients split with 8% carbohydrates, 15% protein and 77% fat.
Also there will be a 0.66 ratio saturated:unsaturated fat
|
|
다른: Sequence 2
Participants will follow a 1) low-carbohydrate diet, wash-out, 2) control diet, wash-out, 3) low-carbohydrate diet, wash-out, 4) control diet, wash-out, 5) control diet, wash-out, 6) low-carbohydrate diet
|
Diet will have macronutrients split with 50% carbohydrates, 15% protein and 35% fat.
Also there will be a 0.66 ratio saturated:unsaturated fat
Diet will have macronutrients split with 8% carbohydrates, 15% protein and 77% fat.
Also there will be a 0.66 ratio saturated:unsaturated fat
|
|
다른: Sequence 3
Participants will follow a 1) low-carbohydrate diet, wash-out, 2) control diet, wash-out, 3) control diet, wash-out, 4) low-carbohydrate diet, wash-out, 5) control diet, wash-out, 6) low-carbohydrate diet
|
Diet will have macronutrients split with 50% carbohydrates, 15% protein and 35% fat.
Also there will be a 0.66 ratio saturated:unsaturated fat
Diet will have macronutrients split with 8% carbohydrates, 15% protein and 77% fat.
Also there will be a 0.66 ratio saturated:unsaturated fat
|
|
다른: Sequence 4
Participants will follow a 1) low-carbohydrate diet, wash-out, 2) control diet, wash-out, 3) control diet, wash-out, 4) low-carbohydrate diet, wash-out, 5) low-carbohydrate diet, wash-out, 6) control diet
|
Diet will have macronutrients split with 50% carbohydrates, 15% protein and 35% fat.
Also there will be a 0.66 ratio saturated:unsaturated fat
Diet will have macronutrients split with 8% carbohydrates, 15% protein and 77% fat.
Also there will be a 0.66 ratio saturated:unsaturated fat
|
|
다른: Sequence 5
Participants will follow a 1) control diet, wash-out, 2) low-carbohydrate diet, wash-out, 3) control diet, wash-out, 4) low-carbohydrate diet, wash-out, 5) control diet, wash-out, 6) low-carbohydrate diet
|
Diet will have macronutrients split with 50% carbohydrates, 15% protein and 35% fat.
Also there will be a 0.66 ratio saturated:unsaturated fat
Diet will have macronutrients split with 8% carbohydrates, 15% protein and 77% fat.
Also there will be a 0.66 ratio saturated:unsaturated fat
|
|
다른: Sequence 6
Participants will follow a 1) control diet, wash-out, 2) low-carbohydrate diet, wash-out, 3) control diet, wash-out, 4) low-carbohydrate diet, wash-out, 5) low-carbohydrate diet, wash-out, 6) control diet
|
Diet will have macronutrients split with 50% carbohydrates, 15% protein and 35% fat.
Also there will be a 0.66 ratio saturated:unsaturated fat
Diet will have macronutrients split with 8% carbohydrates, 15% protein and 77% fat.
Also there will be a 0.66 ratio saturated:unsaturated fat
|
|
다른: Sequence 7
Participants will follow a 1) control diet, wash-out, 2) low-carbohydrate diet, wash-out, 3) low-carbohydrate diet, wash-out, 4) control diet, wash-out, 5) control diet, wash-out, 6) low-carbohydrate diet
|
Diet will have macronutrients split with 50% carbohydrates, 15% protein and 35% fat.
Also there will be a 0.66 ratio saturated:unsaturated fat
Diet will have macronutrients split with 8% carbohydrates, 15% protein and 77% fat.
Also there will be a 0.66 ratio saturated:unsaturated fat
|
|
다른: Sequence 8
Participants will follow a 1) control diet, wash-out, 2) low-carbohydrate diet, wash-out, 3) low-carbohydrate diet, wash-out, 4) control diet, wash-out, 5) low-carbohydrate diet, wash-out, 6) control diet
|
Diet will have macronutrients split with 50% carbohydrates, 15% protein and 35% fat.
Also there will be a 0.66 ratio saturated:unsaturated fat
Diet will have macronutrients split with 8% carbohydrates, 15% protein and 77% fat.
Also there will be a 0.66 ratio saturated:unsaturated fat
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Fasted plasma Low-density lipoprotein cholesterol (LDL-C) concentrations
기간: Pre and post following each intervention/control diet for 24 hours
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Variable will be used to establish whether there is true inter-individual heterogeneity in response to 24 hours of a low-carbohydrate diet. Measured in mmol/L. |
Pre and post following each intervention/control diet for 24 hours
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Fasted glucose plasma glucose concentration
기간: Pre and post following each intervention/control diet for 24 hours
|
Variable measured to establish whether there is true inter-individual heterogeneity in response to 24 hours of a low-carbohydrate diet. Measured in mmol/L |
Pre and post following each intervention/control diet for 24 hours
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Javier Gonzalez, PhD, University of Bath
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2026년 2월 5일
기본 완료 (추정된)
2027년 3월 1일
연구 완료 (추정된)
2027년 3월 1일
연구 등록 날짜
최초 제출
2026년 5월 5일
QC 기준을 충족하는 최초 제출
2026년 6월 25일
처음 게시됨 (실제)
2026년 6월 30일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 30일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 6월 25일
마지막으로 확인됨
2026년 6월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 8791-12081
약물 및 장치 정보, 연구 문서
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아니
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