Effect of Plant Sterol Enriched Milk on Plasma Lipid Levels of Humans Breast-fed During Infancy
Effect of a Plant Sterol-Fortified Low-fat Milk Product on Plasma Lipid Levels of Humans in Relation to Different Infant Feeding Practices and Later Life Cholesterol Metabolism
調査の概要
詳細な説明
Hypothesis 1: To determine the responsiveness of plasma lipid profile including Total cholesterol and LDL cholesterol concentrations to high and low cholesterol diets in adults who been breast-fed as infants for different durations
Hypothesis 2: To determine if differences exist in rates of cholesterol absorption and synthesis in adults, and whether such differences respond to variations in cholesterol intake, between individuals who were breast for different durations.
Hypothesis 3: Consumption of a plant sterol formulation in low-fat milk product will favorably alter lipid profiles compared with control in the study population.
This is a free-living, randomized, crossover trial. This trial is modeled after previously successful functional food trial at the investigators clinic, consistent with current recommendations to decrease Cardiovascular diseases (CVD) risk and improve circulating lipid profiles. The proposed study will include three treatment phases of 4 weeks each, separated by 4-week washout intervals:
Phase 1: Study diets with placebo (240 ml of 2% milk shake; 50 mg cholesterol).
Phase 2: Study diets with enriched cholesterol (240ml of 2% milk shake; 600 mg cholesterol).
Phase 3: A study diet with plant sterols (240 ml of 2% milk shake;2.0 g/d of plant sterols/240 ml serving; 50 mg cholesterol).
During each treatment period participants will consume their supper time meal along with assigned test product. Consumption of the suppertime meals and the test products will be monitored by a clinical coordinator to ensure compliance. Participants will be asked to fill out a 3-day food diary at the beginning and end of each experimental period.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Manitoba
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Winnipeg、Manitoba、カナダ、R3T 2N2
- Richardson Centre for Functional Foods and Nutraceuticals
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Triglycerides (TG) <3.0 mmol/L
- Body mass index (BMI) between 20 and 30 kg/m2
- Participants must have been breast-fed at least during the first 6 months of their life
Exclusion Criteria:
- History of recent (i.e. less than 1 month) or chronic use of oral hypolipidemic therapy, including fish oils, or probucol within the last 3 months
- History of chronic use of alcohol (>2 drinks/d), smoking, systemic antibodies, corticosteroids, androgens, or phenytoin
- Myocardial infarction, coronary artery bypass, kidney disease, liver disease or other major surgical procedures within the last six months,
- Sitosterolemic patients
- Recent onset of angina, congestive heart failure, inflammatory bowel disease, pancreatitis, diabetes, or significant current (i.e. onset within past three months) gastrointestinal, renal, pulmonary, hepatic or biliary disease, or cancer (evidence of active lesions, chemotherapy or surgery in the past year)
- Exercise greater than walking or running 15 miles/wk or 4,000 kcal/wk
- Participants who have not been breast-fed at all
- Pregnant or planning for pregnancy during the next 5 month period
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 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：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：High cholesterol
600 mg cholesterol/day in 240 ml milk shake
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実験的：Plant sterols
2.0 g of plant sterols/day in 240 ml milk shake containing 50 mg cholesterol
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プラセボコンパレーター：Placebo
50 mg cholesterol/day in 240 ml of milk shake
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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 |
時間枠 |
|---|---|
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Change in LDL-cholesterol
時間枠：Day 1,2 & 29,30 of each of the 3 phases. Each phase duration is 1 month
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Day 1,2 & 29,30 of each of the 3 phases. Each phase duration is 1 month
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Cholesterol Absorption
時間枠：Day 26-30 of each of the 3 phases. Each phase duration is 1 month
|
On day 26 of each dietary phase,a 12-hr fasting blood sample will be obtained to represent stable isotope baseline, after which participants will ingest 75 mg of the stable carbon isotope [3,4-13C] cholesterol stable isotope (13C-cholesterol)dissolved in 5 g of margarine and spread on half of an English muffin.
Fasting blood samples will be taken also on days 27, 28, and 29 to monitor isotopic enrichment/decay levels.
Free cholesterol extracted from the Red Blood Cell (RBC) fraction of blood will be used to determine 13C-cholesterol enrichment using on-line gas chromatography (GC)/combustion/isotope ratio mass spectrometry (IRMS)using previously established methods.
Carbon-di-oxide (CO2) gas will be analyzed for 13C cholesterol enrichment against the Pee Dee Belemnite (PDB).
From 24 to 96 hr, cholesterol absorption will be presented as area under the 13C cholesterol RBC enrichment curve calculated by the Number cruncher statistical system (NCSS) statistical software.
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Day 26-30 of each of the 3 phases. Each phase duration is 1 month
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Change in Cholesterol Synthesis
時間枠：Day 26-30 of each of the 3 phases. Each phase duration is 1 month
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On day 29 prior to breakfast, participants will consume 0.7 g/kg estimated body water (estimated at 60% of total body weight) of deuterium oxide (2H) as a tracer to measure cholesterol synthesis.
Fasting blood sample will be collected after 24 hr (96 h after initial isotope administration) in order to monitor the change in deuterium enrichment within red blood cell (RBC) free cholesterol as an index of cholesterol synthesis.Free cholesterol will be extracted from RBC and water from plasma will be isolated using the blood samples collected from day 26-30 each phase.
Cholesterol deuterium enrichment will be determined through being expressed relative to a series of standards using a GC/pyrolysis/IRMS using previously established methods.
Cholesterol fractional synthesis rate (FSR) (% per day)will be calculated as the rate of incorporation of deuterium within the body water pool into RBC cholesterol pools by measuring the deuterium RBC enrichment over 24 hr.
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Day 26-30 of each of the 3 phases. Each phase duration is 1 month
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Peter JH Jones, PhD、University of Manitoba
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- B2013:019
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