PMID- 36650599
OWN - NLM
STAT- MEDLINE
DCOM- 20230119
LR  - 20230120
IS  - 1745-6215 (Electronic)
IS  - 1745-6215 (Linking)
VI  - 24
IP  - 1
DP  - 2023 Jan 17
TI  - The effect of bitter almond (Amygdalus communis L. var. Amara) gum as a 
      functional food on metabolic profile, inflammatory markers, and mental health in 
      type 2 diabetes women: a blinded randomized controlled trial protocol.
PG  - 35
LID - 10.1186/s13063-023-07085-7 [doi]
LID - 35
AB  - BACKGROUND: Using functional foods in the prevention and treatment of type 2 
      diabetes mellitus (T2DM) has increased across the world owing to their 
      availability, cultural acceptability, and lower side effects. The present study 
      will aim to examine the impact of bitter almond (Amygdalus communis L. var. 
      Amara) gum as a functional food on metabolic profile, inflammatory markers, and 
      mental health in women with T2DM. METHODS: We will conduct a randomized, 
      triple-blind, placebo-controlled trial. A total of 44 women with T2DM will be 
      randomly allocated into two groups: an intervention group (n = 20) and a placebo 
      group (n = 20). Patients will receive either 5 g/d of bitter melon gum or a 
      placebo for 8 weeks. Clinical and biochemical outcome parameters which include 
      glycemic indices, lipid profile, inflammatory markers, oxidative stress indices, 
      tryptophan (Trp), kynurenine (KYN), cortisol, glucagon-like peptide 1 (GLP-1), 
      leptin, adiponectin, ghrelin, peroxisome proliferator-activated receptor (PPAR) 
      gene expression, brain-derived neurotrophic factor (BDNF), endothelial cell 
      adhesion molecules, plasminogen, cluster deference 4 (CD4), cluster deference 8 
      (CD8), anthropometric indices, blood pressure, dietary intake, and mental health 
      will be measured at the baseline and end of the study. Statistical analysis will 
      be conducted using the SPSS software (version 24), and P value less than 0.05 
      will be considered statistically significant. DISCUSSION: The present randomized 
      controlled trial will aim to investigate any beneficial effects of bitter almond 
      gum supplementation on the cardio-metabolic, immune-inflammatory, and oxidative 
      stress biomarkers, as well as mental health in women with T2DM. ETHICS AND 
      DISSEMINATION: The study protocol was approved by the Ethical Committee of the 
      Tabriz University of Medical Sciences (IR.TBZMED.REC.1399.726). TRIAL 
      REGISTRATION: Iranian Registry of Clinical Trials ( 
      www.irct.ir/IRCT20150205020965N7 ).
CI  - (c) 2023. The Author(s).
FAU - Saati, Saba
AU  - Saati S
AD  - Student Research Committee, Faculty of Nutrition and Food Science, Tabriz 
      University of Medical Sciences, Tabriz, Iran.
FAU - Dehghan, Parvin
AU  - Dehghan P
AD  - Nutrition Research Center, Department of Biochemistry and Diet Therapy Faculty of 
      Nutrition and Food Science, Tabriz University of Medical Sciences, Tabriz, 
      5166614711, Iran. dehghan.nut@gmail.com.
FAU - Azizi-Soleiman, Fatemeh
AU  - Azizi-Soleiman F
AD  - Department of Nutrition, School of Health, Arak University of Medical Sciences, 
      Arak, Iran.
FAU - Mobasseri, Majid
AU  - Mobasseri M
AD  - Department of Internal Medicine, School of Medicine, Tabriz University of Medical 
      Sciences, Tabriz, Iran.
LA  - eng
GR  - IR.TBZMED.REC.1399.726/Tabriz University of Medical Sciences/
PT  - Clinical Trial Protocol
PT  - Journal Article
DEP - 20230117
PL  - England
TA  - Trials
JT  - Trials
JID - 101263253
SB  - IM
MH  - Humans
MH  - Female
MH  - *Diabetes Mellitus, Type 2/diagnosis/drug therapy
MH  - Functional Food
MH  - *Prunus dulcis
MH  - Mental Health
MH  - Iran
MH  - Metabolome
MH  - Double-Blind Method
MH  - Dietary Supplements
MH  - Randomized Controlled Trials as Topic
PMC - PMC9847170
OTO - NOTNLM
OT  - Bitter almond
OT  - Inflammation
OT  - Oxidative stress
OT  - Type 2 diabetes
COIS- The authors declare that they have no competing interests.
EDAT- 2023/01/18 06:00
MHDA- 2023/01/20 06:00
PMCR- 2023/01/17
CRDT- 2023/01/17 23:35
PHST- 2022/11/19 00:00 [received]
PHST- 2023/01/09 00:00 [accepted]
PHST- 2023/01/17 23:35 [entrez]
PHST- 2023/01/18 06:00 [pubmed]
PHST- 2023/01/20 06:00 [medline]
PHST- 2023/01/17 00:00 [pmc-release]
AID - 10.1186/s13063-023-07085-7 [pii]
AID - 7085 [pii]
AID - 10.1186/s13063-023-07085-7 [doi]
PST - epublish
SO  - Trials. 2023 Jan 17;24(1):35. doi: 10.1186/s13063-023-07085-7.