Do Precision and Personalised Nutrition Interventions Improve Risk Factors in Adults with Prediabetes or Metabolic Syndrome? A Systematic Review of Randomised Controlled Trials
Abstract
:1. Introduction
2. Materials and Methods
2.1. Protocol and Registration
2.2. Database and Search
2.3. Study Selection Criteria
2.4. Study Selection
2.5. Risk of Bias and Study Quality Assessment
2.6. Data Extraction
2.7. Synthesis of Results
3. Results
3.1. Search Results
3.2. Characteristics of the Included Studies
3.3. Quality Assessment of Studies
3.4. Interventions
3.5. Comparators
3.6. Outcome Measures
3.6.1. Glycaemic Control Outcomes
3.6.2. Anthropometric Outcomes
3.6.3. Blood Lipids
3.6.4. Blood Pressure
3.6.5. Dietary Outcomes
4. Discussion
4.1. Strengths and Limitations
4.2. Recommendations
5. Conclusions
Supplementary Materials
Funding
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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Category | Inclusion Criteria | Exclusion Criteria |
---|---|---|
Population | Adults (≥18 yrs) diagnosed with prediabetes or metabolic syndrome | Study participants diagnosed with a chronic disease (e.g., type 1 or 2 diabetes, cardiovascular disease, chronic kidney disease, or gestational diabetes) |
Intervention | MNT (provided by a registered or accredited practising dietitian) or PPN | If the intervention included medications, surgeries, supplements, physical activity, or another lifestyle component, where the impact of the PPN intervention could not be isolated |
Comparison | Standard care, habitual diet, or non-personalised dietary intervention | If the comparator or control was anything other than standard care or non-personalised/individualised dietary intervention |
Outcome | Measures of glycaemic control [HbA1c, fasting blood glucose levels, post-prandial glucose/OGTT, Homeostatic Model Assessment for Insulin Resistance (HOMA-IR), insulin levels, and insulin sensitivity], anthropometry [weight, waist circumference, body mass index (BMI)], blood lipids, blood pressure, and reporting of dietary outcomes (nutrients, food groups, dietary patterns, diet quality) | Did not measure any outcome of interest relating to glycaemic control |
Study design | Randomised control trials (RCTs) published after the year 2000 | Studies that were not an RCT; studies not published in English |
First Author, Year, Country | Primary Risk | Participant Characteristics | RCT Design and Study Duration | Outcomes Measured | Intervention Prescribed By | Intervention Group(s) Conditions | Comparison Group(s) Conditions | Glycaemic Control Outcomes | Anthropometry Outcomes | Blood Lipids | Blood Pressure | Diet |
---|---|---|---|---|---|---|---|---|---|---|---|---|
Ben-Yacov et al., 2021, Israel [24] | Prediabetes | N = 225 (35–70 yrs; 41% male) | Parallel, 1 year | Glycaemic control (FBGL, 2-h and 5-h PPG (CGM), mean CGM glucose, HbA1c, HOMA-IR, insulin, and fructosamine), anthropometry (weight, BMI, waist circumference [WC]), blood lipids, blood pressure (SBP, DBP), and diet (daily food log via smartphone app) | Intervention: one-on-one counselling with a dietitian Control: one-on-one counselling with a dietitian | A tailored diet was created based on the participant’s personal predicted glucose responses using an algorithm that integrated clinical and gut microbiome features. Monthly in-person meetings with a dietitian during 6 months of follow-up and interim contact via telephone or email with a dietitian as needed. Diet recommendations were administered as menus | Monthly in-person meetings with a dietitian during 6 months of follow-up and interim contact via telephone or email with a dietitian as needed. The participants were encouraged to consume a Mediterranean diet consisting of whole foods and discouraged from consuming processed foods. Diet recommendations were administered as menus | Greater improvements in CGM mean above 140 (95% CI −1.29 to −0.66 h/day, p < 0.001), HbA1c (−0.14 to −0.02% [−1.5 to −0.2 mmol/mol], p = 0.007), 5-h PPG excursions (95% CI −12.3 to −7.6 mg/dL × h, p < 0.001), and mean CGM glucose (95% CI −7.0 to −3.22 mg/dL [−0.39 to −0.18 mmol/L], p < 0.001) in intervention group compared to control at 6 months. No significant difference between groups for fasting BGL, insulin, HOMA-IR, and 2-h PG (OGTT) | No significant difference between groups for BMI, weight, and fat (%) at 6 months | Greater improvements in triglycerides (95% CI −0.36 to −0.07 mmol/L [−31.51 to −6.11 mg/dL], p < 0.003) and HDL (95% CI 0.02–0.13 mmol/L [0.77–4.9 mg/dL], p = 0.003) in intervention group compared to control at 6 months. No significant difference for LDL and total cholesterol | No significant difference between groups | Significant difference between groups, with lower carbohydrate intake (−93.2, 95% CI −101.9 g to −84.4 g/d, p < 0.001), fibre intake (−10.8, 95% CI −12.9 to −8.7 g/day, p < 0.01), greater protein intake (+5.1, 95% CI +0.5 to +10.8 g/d, p < 0.001), and fat intake (+37.1, 95% CI +32.1 to +42.1 g/d, p < 0.001) and saturated fat intake (+11.5, 95% CI +9.7 to +13.2 g/d, p < 0.001) observed in the intervention group compared to the control group at 6 months. No significant difference between groups for energy intake. Reported participants’ top 10 most popular logged foods for the intervention and control diets, which differed; however, the authors did not report statistical between-group differences. |
Cole et al., 2013, USA [28] | Prediabetes | N = 65 (≥18 yrs; 54% male) | Parallel, 1 year | Glycaemic control (FBGL, HbA1c), anthropometry (weight, BMI), blood lipids, and blood pressure (SBP, DBP) | Intervention: one-on-one counselling session with a dietitian Control: small medical appointments (SMA) with a dietitian, diabetes educator, and behaviour specialist or nurse | Participants attended at least one 45–60-min individualised counselling session with a dietitian following an initial 3-h prediabetes class. The dietitian discussed patients’ clinical outcomes and progress made in achieving lifestyle medication since the initial class, assisted in the development of SMART goals, and scheduled follow-up appointments if the patient desired | Participants participated in 3 90-min SMA that accommodated 6–8 participants and were supported by dietitians, diabetes educators, and behaviour specialists or nurses. Each participant also received 10 min of individual time to discuss clinical and biochemical measures, challenges, and smart goals | No significant difference between groups for FBGL and HbA1c | No significant difference between groups for weight and BMI | No significant difference between groups for total cholesterol, HDL, LDL, and triglycerides | No significant difference between groups for systolic and diastolic BP | n/a |
Dorans et al., 2022, USA [27] | HbA1c 6.0–6.9% | N = 150 (40–70 yrs; 28% male) | Parallel, 6 months | Glycaemic control (FBGL, mean 24-h CGM glucose, HbA1c, HOMA-IR, and fasting insulin), anthropometry (weight, waist circumference [WC]), blood lipids, blood pressure (SBP, DBP), and diet (24-h recall) | Intervention: one-on-one counselling from an interventionist Control: received written information from the interventionist | Phase 1: The participant received behavioural counselling and key supplemental food with a carbohydrate target of less than 40 g. This phase involved weekly individual sessions for 4 weeks, followed by 4 small group sessions every other week and 4 telephone follow-ups. Phase 2: net carbohydrate target was less than 60 g. During this phase, participant attended three monthly group sessions and three telephone follow-ups | Participants received written information with standard dietary advice and did not receive ongoing recommendations. Participants were offered optional monthly educational sessions on topics unrelated to diet | Greater improvements in HbA1c (−0.23, 95% CI −0.32 to −0.14%, <0.001), FBGL (−10.3, 95% CI −15.6 to −4.9 mg/dL, p = 0.001), fasting insulin (−6.2, 95% CI −10.5 to −2 µIU/mL, p = 0.004), HOMA-IR (−2.4, 95% CI −3.7 to −1.1, p < 0.001) and mean 24-h CGM glucose (−7, 95% CI −13.8 to −0.1 mg/dL, p < 0.05) in intervention group compared to control at 6 months | Greater improvements in weight (−5.9, 95% CI −7.4 to −4.4 kg, p < 0.001) and waist circumference (−4.7, 95% CI −6.7 to −2.6 cm, p < 0.001) in intervention group compared to control at 6 months | No significant difference in HDL, LDL, and total-to-HDL between groups | No significant difference between groups for systolic and diastolic blood pressure | Did not report on difference between groups |
Esposito et al., 2004, Italy [25] | Metabolic syndrome | N = 180 (≥18 yrs; 55% male) | Parallel, 2 years | Glycaemic control (BGL, HOMA-IR, fasting insulin), anthropometry (weight, BMI, waist circumference [WC]), blood lipids, blood pressure (SBP, DBP), and diet (3-day food record) | Intervention: one-on-one counselling provided by nutritionist Control: One-on-one visits with study personnel | Patients were given detailed advice through monthly group sessions. Received education on reducing dietary calories, goal-setting, and self-monitoring using food diaries. Behavioural and psychological counselling was also offered. The dietary advice was tailored to each patient on the basis of 3-day food records. The recommended composition of the dietary regimen was as follows: carbohydrates, 50% to 60%; proteins, 15% to 20%; total fat, less than 30%; saturated fat, less than 10%; and cholesterol consumption, less than 300 mg per day. Patients were advised to increase intake of fruit, vegetables, whole grains, walnuts, and olive oil. Received guidance on increasing their level of physical activity | Patients were given general oral and written information about health food choices at visits but were offered no specific individualized program. The general recommendation for macronutrient composition of the diet was carbohydrates, 50–60%; proteins, 15–20%; and total fat, <30%. Received guidance on increasing their level of physical activity | Greater improvements in BGL (−6, 95% CI −11 to −2 mg/dL. p < 0.001), insulin (−3.5, 95% CI −6.1 to −1.7 µIU/mL, p = 0.01), and HOMA score (−1.1, 95% CI −1.9 to −0.3, p < 0.001) in intervention group compared to control at 2 years | Greater improvements in weight (−2.8, 95% CI −5.1 to −0.5 kg, p < 0.001), BMI (−0.8, 95% CI −1.4 to −0.2 kg/m2, p = 0.01), and waist circumference (−2, 95% CI −3.5 to −0.5 cm, p = 0.01) in intervention group compared to control at 2 years | Greater improvements in total cholesterol (−9, 95% CI −17 to −1 mg/dL, p = 0.02), HDL (+3, 95% CI 0.8 to 5.2 mg/dL, p = 0.03), and triglycerides (−19, 95% CI −32 to −6 mg/dL, p = 0.001) in intervention group compared to control at 2 years | Greater improvement in systolic blood pressure (−3, 95% CI −5 to −1 mmHg, p = 0.01) and diastolic blood pressure (−2, 95% CI −3.5 to −0.5 mmHg, p = 0.03) in intervention group compared to control at 2 years | Greater reductions in energy intakes (−100, 95% CI −178 to −21 kcal/d, p < 0.001), fat (−1.4, 95% CI −2.8 to −0.2%, p = 0.02), SFA (−5.3, 95% CI −9.5 to −2.0%, p < 0.001), omega 6/3 ratio (−4.3, 95% CI −8.3 to −1, p < 0.001), and dietary cholesterol (−80, 95% CI −135 to −25 mg/d, p < 0.001) in intervention group compared to control. Greater increases in carbohydrate intake (+0.6, 95% CI +0.1 to +1.1%, p = 0.02), complex carbohydrate (+7, 95% CI +4 to +12%, p < 0.001), fibre (+16, 95% CI +4 to +30 g/day, p < 0.001), MUFA (+3, 95% CI +1.0 to +5.0%, p < 0.001), PUFA (+0.9, 95% CI +0.3 to +1.5, p = 0.01), and Omega 3 FA (+0.86, +0.25 to +1.4 g/day, p < 0.001) in intervention group compared to control at 2 years. No significant differences between groups for protein intake. At the food group level, significant improvement in olive oil (+8.2, 95% CI +3.3 to +12.4 g/d, p < 0.001), fruits, vegetables, nuts and legumes (+274, 95% CI +176 to +372 g/d, p < 0.001), and wholegrains (+103, 95% CI +45 to +159 g/d, p < 0.001) reported in the intervention group compared to the control group at 2 years. No significant between-group differences for alcohol consumption |
Kolehmainen et al., 2007, Finland [26] | Impaired fasting glycemia or impaired glucose tolerance and features of metabolic syndrome | N = 46 (40–70 yrs; 43% male) | Parallel, 33 weeks | Glycaemic control (FBGL, fasting insulin, insulin sensitivity index, acute insulin response, glucose effectiveness index), anthropometry (weight, BMI, waist circumference [WC]), and diet (4-day food record) | Intervention: One-on-one counselling provided by a nutritionist Control: instructions by research personnel | Subjects underwent 12-week intensive weight reduction program followed by ~20-week weight maintenance. Received individual counselling from nutritionist based on food records, aiming to decrease energy intake. Follow-up meeting with nutritionist to check food record and discuss any difficulties. Subjects asked to maintain physical activity levels | Subjects were advised to continue normal lifestyle and to keep diet and exercise habits unchanged | No significant difference between groups for fasting FBGL, fasting insulin, insulin sensitivity index, acute insulin response, and glucose effectiveness index | Greater improvements in weight (p = 0.0002), BMI (p = 0.0002), and waist circumference (p = 0.0001) in intervention group compared to control at 33 weeks. Paper did not report mean difference/change between groups but reported mean change within groups from baseline | n/a | n/a | Significant decrease in MUFA intake (% energy) in the intervention versus the control (p = 0.013). No significant between-group difference for energy, protein, fat, SFA, PUFAs, carbohydrates, dietary cholesterol, fibre, and calcium intake |
Pimentel et al., 2010, Brazil [29] | Impaired glucose tolerance and one other risk factor for T2DM | N = 51 (≥18 yrs 33–38% male at baseline) | Parallel, 1 year | Glycaemic control (FBGL, PPG and post-prandial insulin, HbA1c, HOMA-IR, fasting insulin), anthropometry (weight, BMI), blood lipids, and diet (7-day food record) | Intervention: one-on-one counselling and group counselling from nutritionist Control: no information provided | Participants received individual and group counselling from team of nutritionists. Consisted of discussion-format group sessions twice a month and individual sessions one per month. Instructions to improve diet quality provided orally and in written form | Control: No information provided. | Greater improvements in HbA1c (p < 0.05), PPG (p < 0.05), post-prandial insulin (p < 0.05), and FBGL (p < 0.05) in the intervention group compared to control at 1 year. No significant difference between groups for fasting insulin and HOMA-IR. Paper did not report mean difference/change between groups but reported significance | No significant difference between groups for weight and BMI | Greater improvements in total cholesterol (p < 0.05) in intervention group compared to control at 1 year. No significant difference reported between groups for HDL, LDL, and triglycerides Paper did not report mean difference/change between groups but reported significance | n/a | Greater improvements in dietetic (dietary) cholesterol (p < 0.05) in intervention group compared to control at 1 year. No significant difference between groups for energy, carbohydrate, protein, fat, and saturated fat. Paper did not report mean difference/change between groups but reported significance |
Watanabe et al., 2003, Japan [23] | Borderline diabetes (patients with 1-h PG ≥10 mmol/L) | N = 156 (35–70 yrs; 100% male) | Parallel, 1 year | Glycaemic control (FBGL, 1-h, and 2-h PPG) and diet (FFQW65) | Intervention: one-on-one counselling was provided by a nutritionist, and additional resources were sent via post Control: Provided with oral and written information by the interventionist | Phase 1: Individualised counselling was received using a booklet explaining the concepts of the new dietary education (NDE) program. Information was provided on dietary intake based on a food frequency questionnaire and motivation to improve dietary practices. Phase 2: The following resources were sent via post: letter encouraging the subject to improve dietary habits, examples of menus corresponding to the subject’s RDA and information to confirm the necessity of blood glucose control | General oral and written information about results of health examination and food frequency questionnaire without detailed explanation. Received conventional group counselling using leaflet with general information on prevention of lifestyle-related diseases | Greater improvement in 2-h PPG (−15.2%, 95% CI −22.0 to −8.4%, p < 0.001) in the intervention group compared to control at 1 year. No significant difference for fasting BGL and 1-h PPG between groups | n/a Measured at baseline but not reported at follow-up visit | n/a Measured at baseline but not reported at follow-up visit | n/a Measured at baseline but not reported at follow-up visit | Greater improvement in daily absolute value of “overintake/underintake fraction” for total energy intake (%) (−6.0%, 95% CI −9.8 to −2.2%, p = 0.002) and dinner (−15.3%, 95% CI −24.6 to −6.0%, p = 0.002) in the intervention group compared to control at 1 year. No significant difference for absolute value of “overintake/underintake fraction” for total energy intake (%) during breakfast and lunch between groups |
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Robertson, S.; Clarke, E.D.; Gómez-Martín, M.; Cross, V.; Collins, C.E.; Stanford, J. Do Precision and Personalised Nutrition Interventions Improve Risk Factors in Adults with Prediabetes or Metabolic Syndrome? A Systematic Review of Randomised Controlled Trials. Nutrients 2024, 16, 1479. https://doi.org/10.3390/nu16101479
Robertson S, Clarke ED, Gómez-Martín M, Cross V, Collins CE, Stanford J. Do Precision and Personalised Nutrition Interventions Improve Risk Factors in Adults with Prediabetes or Metabolic Syndrome? A Systematic Review of Randomised Controlled Trials. Nutrients. 2024; 16(10):1479. https://doi.org/10.3390/nu16101479
Chicago/Turabian StyleRobertson, Seaton, Erin D. Clarke, María Gómez-Martín, Victoria Cross, Clare E. Collins, and Jordan Stanford. 2024. "Do Precision and Personalised Nutrition Interventions Improve Risk Factors in Adults with Prediabetes or Metabolic Syndrome? A Systematic Review of Randomised Controlled Trials" Nutrients 16, no. 10: 1479. https://doi.org/10.3390/nu16101479
APA StyleRobertson, S., Clarke, E. D., Gómez-Martín, M., Cross, V., Collins, C. E., & Stanford, J. (2024). Do Precision and Personalised Nutrition Interventions Improve Risk Factors in Adults with Prediabetes or Metabolic Syndrome? A Systematic Review of Randomised Controlled Trials. Nutrients, 16(10), 1479. https://doi.org/10.3390/nu16101479