An interventional study of Lipid Intake and Glucose intake in Atherosclerosis, sponsored by King Saud Bin Abdulaziz University for Health Sciences. Completed. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-06-02.
Sponsored by King Saud Bin Abdulaziz University for Health Sciences · Not applicable, Interventional, and Basic science
Macrophages can exhibit distinct phenotypes and functions in response to stimuli and can polarize into one of three distinct phenotypes: a pro-inflammatory (M1), an anti-inflammatory pro-tissue (M2) and metabolically-activated (MMe) macrophage phenotypes. Thirty-six healthy volunteers were recruited and randomized into one of three macronutrient intake groups (glucose, lipids, proteins). This study measured the effects of macronutrient intake on the macrophage differentiation.
Thirty-six normal healthy adult volunteers of normal weight were recruited into the study. All were normotensive, had a normal lipid profile, normal renal and liver function tests, and were not on any medications. All subjects gave their written, informed consent. Institutional Review Board (IRB) of the Ministry of National Guard Health Affairs (MNGHA) approved the study protocol. The 36 participants were randomly assigned by the primary investigator (PI) following simple randomization procedure (computerized random numbers) to three different groups, each received one type of macronutrient (Glucose, whey proteins or lipids). Following an overnight fast, a baseline blood sample was taken. Subjects were then given either 300 calories of glucose (NERL Trutol 75) or lipids (90 grams whipping cream, 31.5 grams fat, 1.7 grams protein and 2.25 grams carbohydrate) or protein (Isopure unflavored Whey proteins isolate (WPI) powder containing 26 grams per serving of 100% WPI, stripped of fat, carbs, fillers, sugars and lactose) solution over 5 minutes. Cream and protein preparations were diluted with water up to 300 mL solutions. Further blood samples were obtained at 1, 2 and 3 hours after the macronutrient intake. Subjects, either one week before or after the macronutrient challenge, were given 300 mL of water to drink in the fasting state. Blood samples were obtained before and at 1, 2 and 3 h after water intake as well. Each subject served as his/her own control and was randomly given macronutrient or water intake.
1,596 studies on the registry are indexed under Atherosclerosis; 262 are open to participants now.
This study's enrollment of 36 is below the median of 105 across 898 interventional studies indexed under Atherosclerosis.
Browse Atherosclerosis studies →King Saud Bin Abdulaziz University for Health Sciences is the lead sponsor of 4 studies on the registry; none are open to participants now.
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Exclusion Criteria:
12 subjects had 300 Calories of lipids or 300 mL of water. Blood samples were drawn at 0, 1, 2, and 3 hrs post intake. There was a one week period between the 2 intakes.
Dietary Supplement: Lipid Intake
12 subjects had 300 Calories of glucose or 300 mL of water. Blood samples were drawn at 0, 1, 2, and 3 hrs post intake. There was a one week period between the 2 intakes.
Dietary Supplement: Glucose intake
12 subjects had 300 Calories Whey protein intake or 300 mL of water. Blood samples were drawn at 0, 1, 2, and 3 hrs post intake. There was a one week period between the 2 intakes.
Dietary Supplement: Protein intake
90 grams whipping cream, 31.5 grams fat, 1.7 grams protein, and 2.25 grams carbohydrate
300 calories of glucose
Isopure unflavored Whey proteins isolate (WPI) powder containing 26 grams per serving of 100% WPI, stripped of fat, carbs, fillers, sugars, and lactose
Detection of markers of M1 and M2 macrophages
The following markers were used to detect M1 and M2 macrophages (M1:CD86, IL-6, CD11c, and CD169, and M2: CD206, CD163, and CD36)
Time frame: Subject recruitment, enrollment and sample collection were carried out in a period of 3 months. Baseline blood samples were drawn before the caloric or water intake, and subsequent blood samples were drawn at 1-, 2- and 3-hour intervals post the intake
No study locations are listed for this record.
Plan to share: No
Ran from Feb 2016 to primary completion in Apr 2016, 2 months.
Of 187 non-industry interventional studies with no phase under Atherosclerosis, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 55. This study's 2 months is below that.
Counting every sponsor, half of 209 studies reached it within 27 months; a quarter within 16 and three quarters within 56.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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King Saud Bin Abdulaziz University for Health Sciences