Low-carbohydrate Diet and Low-Density Lipoprotein - Cholesterol (LDL-c) Interindividual Variability (REPETO)
2026年6月25日 更新者：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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (推定)
20
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Bruno Spellanzon, PhD candidate
- 電話番号：447769407954
- メール：bs954@bath.ac.uk
研究場所
-
-
Bath and North East Somerset
-
Bath、Bath and North East Somerset、イギリス、BA2 7AY
- 募集
- University of Bath
-
主任研究者：
- Javier Gonzalez, PhD
-
コンタクト：
- Bruno Spellanzon, PhD candidate
- 電話番号：447769407954
- メール：bs954@bath.ac.uk
-
コンタクト：
- Javier Gonzalez, PhD
- メール：jg833@bath.ac.uk
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
はい
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：基礎科学
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
他の：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
|
|
他の：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
|
|
他の：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
|
|
他の：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
|
|
他の：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
|
|
他の：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
|
|
他の：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
|
|
他の：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
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Fasted plasma Low-density lipoprotein cholesterol (LDL-C) concentrations
時間枠：Pre and post following each intervention/control diet for 24 hours
|
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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Fasted glucose plasma glucose concentration
時間枠：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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Javier Gonzalez, PhD、University of Bath
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年2月5日
一次修了 (推定)
2027年3月1日
研究の完了 (推定)
2027年3月1日
試験登録日
最初に提出
2026年5月5日
QC基準を満たした最初の提出物
2026年6月25日
最初の投稿 (実際)
2026年6月30日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月30日
QC基準を満たした最後の更新が送信されました
2026年6月25日
最終確認日
2026年6月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。