Dataset Information

Effect of Date Fruit Consumption on the Glycemic Control of Patients with Type 2 Diabetes: A Randomized Clinical Trial.

ABSTRACT:

Objective

Date fruit has been reported to have benefits in type 2 diabetes (T2D), though there is a concern, given the high sugar content, about its effects on glycemic control.

Design and setting

Prospective, interventional, randomized, parallel study.

Participants

In total, 79 patients with T2D (39 male and 40 female).

Intervention

Participants were randomly allocated to either 60 g date fruit or 60 g raisins daily of the equivalent glycemic index (amount split, given as midmorning and midafternoon snack) for 12 weeks.

Main outcome measures

The primary outcome was to investigate the effect of date fruit on HbA1c and fasting blood glucose, and their variability, in patients with T2D in comparison to the same glycemic load of raisins. The secondary outcomes were to determine whether date fruit affected cardiovascular risk by measuring fasting lipids, C-reactive protein (CRP), blood pressure, and insulin resistance (IR) as measured by Homeostatic Model Assessment (HOMA-IR).

Results

In total, 61 (27 female and 34 male) of 79 patients completed the study. There was no difference between or within groups for HbA1c or HbA1c variability, fasting glucose or glucose variability, insulin resistance (HOMA-IR), insulin sensitivity (HOMA-S), beta cell function (HOMA-B), the disposition index, lipids, systolic (SBP) or diastolic blood pressure (DBP), or C-reactive protein (CRP) (p > 0.05).

Conclusion

No improvement in glycemic indices was seen following supplementation of 60 g daily date fruit or raisins, though neither had a deleterious effect on glycemic control over a 12-week period, indicating their safety when consumed in T2D. Additionally, no beneficial therapeutic effects of date fruit on other cardiovascular indices in T2D were seen.

SUBMITTER: Butler AE

PROVIDER: S-EPMC9458144 | biostudies-literature | 2022 Aug

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Effect of Date Fruit Consumption on the Glycemic Control of Patients with Type 2 Diabetes: A Randomized Clinical Trial.

Butler Alexandra E AE Obaid Jenan J Wasif Pearl P Varghese Jean V JV Abdulrahman Rawan R Alromaihi Dalal D Atkin Stephen L SL Alamuddin Naji N

Nutrients 20220825 17

Objective. Date fruit has been reported to have benefits in type 2 diabetes (T2D), though there is a concern, given the high sugar content, about its effects on glycemic control. Design and Setting. Prospective, interventional, randomized, parallel study. Participants. In total, 79 patients with T2D (39 male and 40 female). Intervention. Participants were randomly allocated to either 60 g date fruit or 60 g raisins daily of the equivalent glycemic index (amount split, given as midmorning and mid ...[more]

PMID: 36079749

Similar Datasets

Project description:BackgroundMedical nutrition therapy is recognized as an important treatment option in type 2 diabetes. Most guidelines recommend eating a diet with a high intake of fiber-rich food including fruit. This is based on the many positive effects of fruit on human health. However some health professionals have concerns that fruit intake has a negative impact on glycemic control and therefore recommend restricting the fruit intake. We found no studies addressing this important clinical question. The objective was to investigate whether an advice to reduce the intake of fruit to patients with type 2 diabetes affects HbA1c, bodyweight, waist circumference and fruit intake.MethodsThis was an open randomized controlled trial with two parallel groups. The primary outcome was a change in HbA1c during 12 weeks of intervention. Participants were randomized to one of two interventions; medical nutrition therapy + advice to consume at least two pieces of fruit a day (high-fruit) or medical nutrition therapy + advice to consume no more than two pieces of fruit a day (low-fruit). All participants had two consultations with a registered dietitian. Fruit intake was self-reported using 3-day fruit records and dietary recalls. All assessments were made by the "intention to treat" principle.ResultsThe study population consisted of 63 men and women with newly diagnosed type 2 diabetes. All patients completed the trial. The high-fruit group increased fruit intake with 125 grams (CI 95%; 78 to 172) and the low-fruit group reduced intake with 51 grams (CI 95%; -18 to -83). HbA1c decreased in both groups with no difference between the groups (diff.: 0.19%, CI 95%; -0.23 to 0.62). Both groups reduced body weight and waist circumference, however there was no difference between the groups.ConclusionsA recommendation to reduce fruit intake as part of standard medical nutrition therapy in overweight patients with newly diagnosed type 2 diabetes resulted in eating less fruit. It had however no effect on HbA1c, weight loss or waist circumference. We recommend that the intake of fruit should not be restricted in patients with type 2 diabetes.Trial registrationhttp://www.clinicaltrials.gov; Identifier: NCT01010594.

Project description:ImportanceIt is unclear whether a lifestyle intervention can maintain glycemic control in patients with type 2 diabetes.ObjectiveTo test whether an intensive lifestyle intervention results in equivalent glycemic control compared with standard care and, secondarily, leads to a reduction in glucose-lowering medication in participants with type 2 diabetes.Design, setting, and participantsRandomized, assessor-blinded, single-center study within Region Zealand and the Capital Region of Denmark (April 2015-August 2016). Ninety-eight adult participants with non-insulin-dependent type 2 diabetes who were diagnosed for less than 10 years were included. Participants were randomly assigned (2:1; stratified by sex) to the lifestyle group (n = 64) or the standard care group (n = 34).InterventionsAll participants received standard care with individual counseling and standardized, blinded, target-driven medical therapy. Additionally, the lifestyle intervention included 5 to 6 weekly aerobic training sessions (duration 30-60 minutes), of which 2 to 3 sessions were combined with resistance training. The lifestyle participants received dietary plans aiming for a body mass index of 25 or less. Participants were followed up for 12 months.Main outcomes and measuresPrimary outcome was change in hemoglobin A1c (HbA1c) from baseline to 12-month follow-up, and equivalence was prespecified by a CI margin of ±0.4% based on the intention-to-treat population. Superiority analysis was performed on the secondary outcome reductions in glucose-lowering medication.ResultsAmong 98 randomized participants (mean age, 54.6 years [SD, 8.9]; women, 47 [48%]; mean baseline HbA1c, 6.7%), 93 participants completed the trial. From baseline to 12-month follow-up, the mean HbA1c level changed from 6.65% to 6.34% in the lifestyle group and from 6.74% to 6.66% in the standard care group (mean between-group difference in change of -0.26% [95% CI, -0.52% to -0.01%]), not meeting the criteria for equivalence (P = .15). Reduction in glucose-lowering medications occurred in 47 participants (73.5%) in the lifestyle group and 9 participants (26.4%) in the standard care group (difference, 47.1 percentage points [95% CI, 28.6-65.3]). There were 32 adverse events (most commonly musculoskeletal pain or discomfort and mild hypoglycemia) in the lifestyle group and 5 in the standard care group.Conclusions and relevanceAmong adults with type 2 diabetes diagnosed for less than 10 years, a lifestyle intervention compared with standard care resulted in a change in glycemic control that did not reach the criterion for equivalence, but was in a direction consistent with benefit. Further research is needed to assess superiority, as well as generalizability and durability of findings.Trial registrationclinicaltrials.gov Identifier: NCT02417012.

Project description:ObjectiveThe purpose of this study was to systematically determine the effect of dragon fruit on glycemic control in prediabetes and type 2 diabetes.MethodsElectronic databases including MEDLINE, CENTRAL, CINAHL, Scopus, ScienceDirect®, Proquest, Web of Science®, LILACS, NAPRALERT, SciFinder, Clinicalkey, Herbmed, NCCIH and Google Scholar were searched from their earliest inception up to March 2017 for relevant randomized controlled trials (RCTs) which compared dragon fruit with placebo or no treatment in prediabetes or type 2 diabetes. Clinicaltrials.gov, clinicaltrialresults.org, and ISRCTN registry were also searched. Personal contact with experts and historical search of related articles was undertaken. Outcome of interest were fasting plasma glucose (FPG) and 2 hours post-prandial glucose (2HPP). Study selection, data extraction and study quality assessment were performed independently by two investigators. Disagreements were resolved by a third reviewer. Treatment effect was estimated with mean difference (MD). Effect estimates were pooled using inverse-variance weighted method. Heterogeneity was assessed with the Q statistic and quantified with the I2 statistic. DerSimonian and Laird random-effects model was used when the Q-statistic was significant at the level of 0.1, otherwise a fixed-effects model was used.ResultsAmong 401 studies identified from literature search, 4 RCTs involving 36 prediabetes subjects and 109 type 2 diabetes patients were included in the analysis. In prediabetes, FPG reduction was significant with MD of -15.1 mg/dL (95% CI: -23.8 to -6.5 mg/dL, P-value = 0.0006). Meta-analysis in type 2 diabetes showed no effect of dragon fruit on FPG (MD -26.5 mg/dL, 95% CI: -72.6 mg/dL to 19.6 mg/dL) and in 2HPP (MD -30.5 mg/dL, 95% CI: -80.9 mg/dL to 19.9 mg/dL).ConclusionThe available evidence in prediabetes is interesting. This will shed some light on diabetes prevention. The effect in T2DM was not significant. However, a trend towards greater blood glucose reduction with higher dose was observed.

Project description:ImportanceNear normalization of glucose levels instituted immediately after diagnosis of type 1 diabetes has been postulated to preserve pancreatic beta cell function by reducing glucotoxicity. Previous studies have been hampered by an inability to achieve tight glycemic goals.ObjectiveTo determine the effectiveness of intensive diabetes management to achieve near normalization of glucose levels on preservation of pancreatic beta cell function in youth with newly diagnosed type 1 diabetes.Design, setting, and participantsThis randomized, double-blind, clinical trial was conducted at 6 centers in the US (randomizations from July 20, 2020, to October 13, 2021; follow-up completed September 15, 2022) and included youths with newly diagnosed type 1 diabetes aged 7 to 17 years.InterventionsRandom assignment to intensive diabetes management, which included use of an automated insulin delivery system (n = 61), or standard care, which included use of a continuous glucose monitor (n = 52), as part of a factorial design in which participants weighing 30 kg or more also were assigned to receive either oral verapamil or placebo.Main outcomes and measuresThe primary outcome was mixed-meal tolerance test-stimulated C-peptide area under the curve (a measure of pancreatic beta cell function) 52 weeks from diagnosis.ResultsAmong 113 participants (mean [SD] age, 11.8 [2.8] years; 49 females [43%]; mean [SD] time from diagnosis to randomization, 24 [5] days), 108 (96%) completed the trial. The mean C-peptide area under the curve decreased from 0.57 pmol/mL at baseline to 0.45 pmol/mL at 52 weeks in the intensive management group, and from 0.60 to 0.50 pmol/mL in the standard care group (treatment group difference, -0.01 [95% CI, -0.11 to 0.10]; P = .89). The mean time in the target range of 70 to 180 mg/dL, measured with continuous glucose monitoring, at 52 weeks was 78% in the intensive management group vs 64% in the standard care group (adjusted difference, 16% [95% CI, 10% to 22%]). One severe hypoglycemia event and 1 diabetic ketoacidosis event occurred in each group.Conclusions and relevanceIn youths with newly diagnosed type 1 diabetes, intensive diabetes management, which included automated insulin delivery, achieved excellent glucose control but did not affect the decline in pancreatic C-peptide secretion at 52 weeks.Trial registrationClinicalTrials.gov Identifier: NCT04233034.

Project description:ImportanceAdolescents and young adults with type 1 diabetes exhibit the worst glycemic control among individuals with type 1 diabetes across the lifespan. Although continuous glucose monitoring (CGM) has been shown to improve glycemic control in adults, its benefit in adolescents and young adults has not been demonstrated.ObjectiveTo determine the effect of CGM on glycemic control in adolescents and young adults with type 1 diabetes.Design, setting, and participantsRandomized clinical trial conducted between January 2018 and May 2019 at 14 endocrinology practices in the US including 153 individuals aged 14 to 24 years with type 1 diabetes and screening hemoglobin A1c (HbA1c) of 7.5% to 10.9%.InterventionsParticipants were randomized 1:1 to undergo CGM (CGM group; n = 74) or usual care using a blood glucose meter for glucose monitoring (blood glucose monitoring [BGM] group; n = 79).Main outcomes and measuresThe primary outcome was change in HbA1c from baseline to 26 weeks. There were 20 secondary outcomes, including additional HbA1c outcomes, CGM glucose metrics, and patient-reported outcomes with adjustment for multiple comparisons to control for the false discovery rate.ResultsAmong the 153 participants (mean [SD] age, 17 [3] years; 76 [50%] were female; mean [SD] diabetes duration, 9 [5] years), 142 (93%) completed the study. In the CGM group, 68% of participants used CGM at least 5 days per week in month 6. Mean HbA1c was 8.9% at baseline and 8.5% at 26 weeks in the CGM group and 8.9% at both baseline and 26 weeks in the BGM group (adjusted between-group difference, -0.37% [95% CI, -0.66% to -0.08%]; P = .01). Of 20 prespecified secondary outcomes, there were statistically significant differences in 3 of 7 binary HbA1c outcomes, 8 of 9 CGM metrics, and 1 of 4 patient-reported outcomes. The most commonly reported adverse events in the CGM and BGM groups were severe hypoglycemia (3 participants with an event in the CGM group and 2 in the BGM group), hyperglycemia/ketosis (1 participant with an event in CGM group and 4 in the BGM group), and diabetic ketoacidosis (3 participants with an event in the CGM group and 1 in the BGM group).Conclusions and relevanceAmong adolescents and young adults with type 1 diabetes, continuous glucose monitoring compared with standard blood glucose monitoring resulted in a small but statistically significant improvement in glycemic control over 26 weeks. Further research is needed to understand the clinical importance of the findings.Trial registrationClinicalTrials.gov Identifier: NCT03263494.

Dataset Information

Effect of Date Fruit Consumption on the Glycemic Control of Patients with Type 2 Diabetes: A Randomized Clinical Trial.

Objective

Design and setting

Participants

Intervention

Main outcome measures

Results

Conclusion

Publications

Effect of Date Fruit Consumption on the Glycemic Control of Patients with Type 2 Diabetes: A Randomized Clinical Trial.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets