- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT04608136
Egg Yolk and Underlying Metabolisms on Modifying HDL Levels in Individuals With Metabolic Syndrome
7 april 2022 uppdaterad av: Mahidol University
Egg Yolk and Underlying Metabolisms on Modifying HDL Levels and Associated Genetics in Individuals With Metabolic Syndrome
This research compare the effects of low carbohydrate intake and consumption of 3 eggs per day, and low energy diet on diabetes control and biomarkers of CVD in obese people.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
This research study examines the effects of changes in weight, metabolism of glucose and cholesterol in the blood through diet and behavior modification.
The main objective of this study was to compare the effects of low carbohydrate intake and consumption of 3 eggs per day, and low energy diet on diabetes control and biomarkers of CVD in obese people.
In addition, HDL quantity and size as well as HDL function was compared between the group who ate the whole egg and the group who did not eat the yolk.
Studietyp
Interventionell
Inskrivning (Faktisk)
76
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Bangkok
-
Bangkok Noi, Bangkok, Thailand, 10700
- Faculty of Medicine Siriraj Hospital, Mahidol University
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 60 år (Vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- weight stable > 3 months (changing < 5%)
- three or more of the following five criteria are met 2.1 waist circumference ≥ 90 cm (men) or ≥ 80 cm (women) 2.2 fasting blood sugar ≥ 100 mg/dl 2.3 fasting triglyceride (TG) level ≥ 150 mg/dl 2.4 fasting high-density lipoprotein (HDL) cholesterol level ≤ 40 mg/dl (men) or ≤ 50 mg/dl (women) 2.5 blood pressure over 130/85 mmHg
- can consume food that provided in project
- healthy
Exclusion Criteria:
- consume drugs i.e. weight loss drugs, herbal pills, asthma drugs, steroid drugs, thyroid drugs, insulin injections, SGLT1 inhibitors drugs, SGLT2 inhibitors drugs, sulfonylurea drugs, blood lipid-lowering drugs
- people who exercise vigorously (> 150 minutes per week)
- people who are or have weight loss by consuming less than 30% of carbohydrates, or are losing weight by other methods or who have eaten a specific diet as prescribed by a doctor within the past 6 months
- people who drink alcohol more than once a week
- people who had a LDL level within 6 months > 190 mg/dl
- fasting blood glucose levels > 250 mg/dl and using diabetes drugs other than metformin
- people with heart disease, type 1 diabetes, renal impairment > level 3A
- history of cancer, lung disease, gastrointestinal disease
- people who smoke, people with eating disorder, people who have received psychiatric drugs
- become a volunteer in a research project that is conducting a study related to food consumption
- people who are unable to keep up with the treatment or are expected to be absent in this area for the next 4 months
- pregnancy or breastfeeding
- egg allergy
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Yolk ketogenic diet
consume carbohydrate < 10% and 3 whole eggs supplement per day in 12 weeks
|
Volunteers will be instructed on dietary recommendation throughout the research program to achieve a stable daily energy intake.
|
|
Experimentell: White ketogenic diet
consume carbohydrate < 10% and 6 white eggs supplement per day in 12 weeks
|
Volunteers will be instructed on dietary recommendation throughout the research program to achieve a stable daily energy intake.
|
|
Aktiv komparator: Control group
decrease consumption of diet from typical (decreased energy 20%) but consume carbohydrate in normal level
|
Volunteers will be instructed on dietary recommendation throughout the research program to achieve a stable daily energy intake.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Changes in weight following dietary intervention
Tidsram: Baseline and after 12 weeks
|
weight (kg) analysis
|
Baseline and after 12 weeks
|
|
Changes in body mass index following dietary intervention
Tidsram: Baseline and after 12 weeks
|
body mass index (kg/m^2) analysis
|
Baseline and after 12 weeks
|
|
Changes in waist circumference following dietary intervention
Tidsram: Baseline and after 12 weeks
|
waist circumference (cm) analysis
|
Baseline and after 12 weeks
|
|
Changes in lipid profiles concentration following dietary intervention
Tidsram: Baseline and after 12 weeks
|
Triglycerides (mg/dl), Cholesterol (mg/dl), HDL-cholesterol (mg/dl) and LDL-cholesterol (mg/dl) concentration analysis
|
Baseline and after 12 weeks
|
|
Changes in blood glucose and insulin concentration following dietary intervention
Tidsram: Baseline and after 12 weeks
|
HbA1C (%), glucose (mg/dl) and insulin (mg/dl) concentration analysis
|
Baseline and after 12 weeks
|
|
Changes in betahydroxybutirate concentration following dietary intervention
Tidsram: Baseline and after 12 weeks
|
betahydroxybutirate (mmol/L) concentration analysis
|
Baseline and after 12 weeks
|
|
Changes in electrolytes concentration following dietary intervention
Tidsram: Baseline and after 12 weeks
|
Na+ (mg/dl), K+ (mg/dl), Cl- (mg/dl) and HCO3- (mg/dl) concentration analysis
|
Baseline and after 12 weeks
|
|
Changes in physical activity
Tidsram: Baseline and after 12 weeks
|
physical activity (MET-minutes/week) collect data by using questionnaires
|
Baseline and after 12 weeks
|
|
Change from baseline Glycemia at 180 minutes
Tidsram: Minutes after intake of 75 g glucose: 0, 30, 60, 90, 120, 180
|
glucose (mg/dl)
|
Minutes after intake of 75 g glucose: 0, 30, 60, 90, 120, 180
|
|
Change from baseline Insulin at 180 minutes
Tidsram: Minutes after intake of 75 g glucose: 0, 30, 60, 90, 120, 180
|
insulin (μU/ml)
|
Minutes after intake of 75 g glucose: 0, 30, 60, 90, 120, 180
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Changes in blood pressure
Tidsram: Baseline and after 12 weeks
|
systolic and diastolic blood pressure (mmHg)
|
Baseline and after 12 weeks
|
|
Changes in fasting leptin levels
Tidsram: Baseline and after 12 weeks
|
leptin (mg/dl) concentration analysis
|
Baseline and after 12 weeks
|
|
Changes in energy intake following dietary intervention
Tidsram: Baseline and after 12 weeks
|
energy (kcal)
|
Baseline and after 12 weeks
|
|
Changes in carbohydrate following dietary intervention
Tidsram: Baseline and after 12 weeks
|
carbohydrate (g)
|
Baseline and after 12 weeks
|
|
Changes in protein intake following dietary intervention
Tidsram: Baseline and after 12 weeks
|
protein (g)
|
Baseline and after 12 weeks
|
|
Changes in fat intake following dietary intervention
Tidsram: Baseline and after 12 weeks
|
fat (g)
|
Baseline and after 12 weeks
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
21 september 2020
Primärt slutförande (Faktisk)
31 maj 2021
Avslutad studie (Faktisk)
31 december 2021
Studieregistreringsdatum
Först inskickad
21 september 2020
Först inskickad som uppfyllde QC-kriterierna
28 oktober 2020
Första postat (Faktisk)
29 oktober 2020
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
8 april 2022
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
7 april 2022
Senast verifierad
1 april 2022
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- MU-CIRB 2019/255.0310
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